- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00042289
Pharmacokinetic Study of Antiretroviral Drugs and Related Drugs During and After Pregnancy
Pharmacokinetic Properties of Antiretroviral and Related Drugs During Pregnancy and Postpartum
Study Overview
Status
Conditions
Intervention / Treatment
- Drug: darunavir/ritonavir dosage #1
- Drug: darunavir/ritonavir dosage #2
- Drug: darunavir/ritonavir dosage #3
- Drug: dolutegravir
- Drug: tenofovir alafenamide fumarate (TAF)
- Drug: TAF w/cobicistat
- Drug: TAF w/cobicistat or ritonavir
- Drug: elvitegravir/cobicistat
- Drug: darunavir/cobicistat
- Drug: atazanavir/cobicistat
- Drug: efavirenz
- Drug: rifampicin
- Drug: ethambutol
- Drug: isoniazid
- Drug: pyrazinamide
- Drug: lopinavir/ritonavir dosage #1
- Drug: kanamycin
- Drug: amikacin
- Drug: capreomycin
- Drug: moxifloxacin
- Drug: levoflaxacin
- Drug: ofloxacin
- Drug: ethionamide/prothionamide
- Drug: terizidone/cycloserine
- Drug: para-aminosalicylic acid (PAS)
- Drug: high dose INH
- Drug: bedaquiline
- Drug: clofazamine
- Drug: delamanid
- Drug: linezolid
- Drug: pretomanid
- Drug: ethinyl estradiol
- Drug: etonogestrel implant
- Drug: atazanavir/ritonavir/tenofovir dosage #1
- Drug: nevirapine
- Drug: amprenavir
- Drug: abacavir
- Drug: lopinavir/ritonavir dosage #2
- Drug: indinavir/ritonavir dosage #1
- Drug: fosamprenavir/ritonavir
- Drug: lopinavir/ritonavir dosage #3
- Drug: atazanavir/ritonavir dosage #1
- Drug: didanosine delayed release (Videx® EC)
- Drug: emtricitabine
- Drug: tenofovir
- Drug: nelfinavir dosage #1
- Drug: tipranavir/ritonavir
- Drug: lopinavir/ritonavir dosage #4
- Drug: raltegravir
- Drug: etravirine
- Drug: maraviroc
- Drug: darunavir/ritonavir dosage #4
- Drug: atazanavir/ritonavir dosage #2
- Drug: tenofovir/atazanavir/ritonavir dosage #2
- Drug: nelfinavir dosage #2
- Drug: indinavir/ritonavir dosage #2
- Drug: rilpivirine
Detailed Description
Pregnant women experience unique physiological changes that may result in clinically significant alterations in drug PKs. Unfortunately, there have been few clinical trials to study the PKs of ARV, TB, and hormonal contraceptive drugs in pregnant women. The development of appropriate dosing regimens for the HIV-infected pregnant woman is critical to the health of both mother and fetus. Overdosing may lead to maternal adverse events and increased risk of fetal toxicity, while underdosing may lead to inadequate virologic control, increased risk of developing drug resistance mutations, and a higher rate of perinatal HIV transmission. This study evaluated the PKs of ARVs used during pregnancy; the PKs of TB drugs used during pregnancy, both in women who are HIV-positive and also taking ARVs and in women who are HIV-negative and not taking ARVs; and the PKs of hormonal contraceptive medications taken along with ARVs.
P1026s is a Phase IV clinical study. Participants were not assigned to the drugs under study, but were already receiving the drugs for clinical care by prescription of their clinical care providers. They were enrolled into study arms according to the drugs they were receiving through clinical care, and if on multiple drugs of interest, were able to enroll into multiple arms simultaneously. No drugs were provided as part of this study. This observational study was added to an existing investigational new drug (IND) number because several of the drugs were studied at a higher does than the approved dose after the PK results for the approved dose were found to be inadequate.
P1026s went through 10 protocol versions, with the first and last versions of the protocol finalized in 2002 and 2016, respectively. New study arms were added and analyzed separately with each update of the protocol version. In general, there were five main groups of study arms: HIV-infected pregnant women taking ARVs without TB treatment, HIV-infected pregnant women taking ARVs with first-line TB treatment, HIV-uninfected pregnant women taking no ARVs with first-line TB treatment, HIV-infected and HIV-uninfected pregnant women with or without ARVs with second-line TB treatment for drug-resistant TB, and HIV-infected postpartum women taking ARVs and hormonal contraceptives. The primary analysis of each arm was designed and conducted as a separate single arm evaluation of the drug (or combination of drugs) of interest.
Women who were 20 0/7 weeks to 37 6/7 weeks pregnant were enrolled in this study and remained in the study for up to 12 weeks after delivery. Postpartum women were enrolled at 2 to 12 weeks after delivery and followed until 6 to 7 weeks after starting contraceptives. Infants were enrolled in-utero and followed for 16 to 24 weeks of life. At all study visits, participants underwent a medical history, a physical exam, and blood collection. At some visits, women in some arms underwent a vaginal swab. Blood collection from the mother and the detached umbilical cord occurred during delivery. Intensive PK sampling was performed at study visits during the second and third trimester of pregnancy and/or postpartum, depending on the study arm. Additional study visits may have occurred depending on the ARV drug regimen prescribed. Infant washout PK samples were collected at 2-10, 18-28, 36-72 hours after birth, and 5-9 days of life.
There are a total of 49 study arms across all versions of P1026s protocols. Out of the 49 study arms, 2 did not have PK data* [didanosine delayed release (DDI) and lopinavir/ritonavir (LPV/RTV) African sites only]; 2 never enrolled any participants [amprenavir (APV) and nevirapine/rifampicin (NVP/RIF) with at least one first line TB drug]; 9 are in the line to be tested/analyzed due to batched analysis which has to be done after the end of the study, the lengthy process of development, validation and approval (regulatory burdens), and laboratory delays related to the COVID-19 pandemic [all TB arms and all but 3 contraceptive arms (atazanavir/ritonavir/tenofovir (ATV/RTV/TFV) with etonogestrel (ENG), efavirenz (EFV) with ENG, and LPV/RTV with ENG)]; and 8 had completion dates earlier than December 26, 2007 [nevirapine (NVP), abacavir (ABC), LPV/RTV 400/100 mg twice daily (b.i.d.), LPV/RTV 400/100mg then 533/133mg b.i.d, nelfinavir (NFV), emtricitabine (FTC), indinavir/ritonavir (IDV/RTV), and tipranavir/ritonavir]. In this submission, the Results Section presents participant flow, baseline characteristics and adverse events for all study arms (except the 2 arms that never enrolled), and outcome measure results for the 28 remaining study arms that have been completed and have final results available. For study arms completed prior to December 26, 2007, refer to the study publications in the References section for outcome measures.
For arms with very low enrollment (N<3), some results throughout the record (e.g. baseline characteristics and outcome measures) were not reported in order to avoid making individual participant data identifiable.
In the Outcome Measures section, there could be multiple outcome measures for same PK parameters (e.g. AUC12) depending on different units or summary statistics used in the analyses (such as median with range vs. median with interquartile range (IQR)).
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Buenos Aires
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Ciudad de Buenos Aires, Buenos Aires, Argentina, C1221ADC
- Hosp. General de Agudos Buenos Aires Argentina NICHD CRS
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Gaborone, Botswana
- Molepolole CRS
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South-East District
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Gaborone, South-East District, Botswana
- Gaborone CRS
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Rio de Janeiro, Brazil, 20221-903
- Hospital Federal dos Servidores do Estado NICHD CRS
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Rio de Janeiro, Brazil, 21941-612
- Instituto de Puericultura e Pediatria Martagao Gesteira - UFRJ NICHD CRS
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Rio de Janeiro, Brazil, 26030
- Hosp. Geral De Nova Igaucu Brazil NICHD CRS
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Rio de Janeiro, Brazil, 20221-903
- Hosp. dos Servidores Rio de Janeiro NICHD CRS
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Sao Paulo, Brazil, 14049-900
- Univ. of Sao Paulo Brazil NICHD CRS
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Minas Gerais
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Belo Horizonte, Minas Gerais, Brazil, 30.130-100
- SOM Federal University Minas Gerais Brazil NICHD CRS
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Rio Grande Do Sul
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Porto Alegre, Rio Grande Do Sul, Brazil, 90020-090
- Hosp. Santa Casa Porto Alegre Brazil NICHD CRS
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San Juan, Puerto Rico, 00936
- San Juan City Hosp. PR NICHD CRS
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San Juan, Puerto Rico, 00935
- IMPAACT/ Gamma Project/ UPR Pediatric HIV/AIDS Research CRS
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Gauteng
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Johannesburg, Gauteng, South Africa, 2001
- Wits RHI Shandukani Research Centre CRS
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Western Cape Province
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Cape Town, Western Cape Province, South Africa, 7505
- Desmond Tutu TB Centre - Stellenbosch University (DTTC-SU) CRS
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Tygerberg, Western Cape Province, South Africa, 7505
- Famcru Crs
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Moshi, Tanzania
- Kilimanjaro Christian Medical Centre (KCMC)
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Chanthaburi, Thailand, 22000
- Prapokklao Hosp. CRS
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Chiang Mai, Thailand, 50200
- Chiang Mai University HIV Treatment (CMU HIV Treatment) CRS
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Chiang Mai, Thailand, 50100
- Chiangrai Prachanukroh Hospital NICHD CRS
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Chon Buri, Thailand, 20000
- Chonburi Hosp. CRS
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Bangkok
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Sai Mai, Bangkok, Thailand, 10220
- Bhumibol Adulyadej Hosp. CRS
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Bangkoknoi
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Bangkok, Bangkoknoi, Thailand, 10700
- Siriraj Hospital ,Mahidol University NICHD CRS
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Phayao
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T.Tom, Muang, Phayao, Thailand, 56000
- Phayao Provincial Hosp. CRS
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Alabama
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Birmingham, Alabama, United States, 35233
- UAB Pediatric Infectious Diseases CRS
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California
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La Jolla, California, United States, 92093-0672
- University of California, UC San Diego CRS- Mother-Child-Adolescent HIV Program
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Long Beach, California, United States, 90806
- Miller Children's Hosp. Long Beach CA NICHD CRS
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Los Angeles, California, United States, 90089
- Usc La Nichd Crs
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Los Angeles, California, United States, 90095-1752
- David Geffen School of Medicine at UCLA NICHD CRS
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San Francisco, California, United States, 94143
- Univ. of California San Francisco NICHD CRS
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Torrance, California, United States, 90502
- Harbor UCLA Medical Ctr. NICHD CRS
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Colorado
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Aurora, Colorado, United States, 80045
- Univ. of Colorado Denver NICHD CRS
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Connecticut
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New Haven, Connecticut, United States, 06510
- Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease
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District of Columbia
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Washington, District of Columbia, United States, 20010
- Washington Hosp. Ctr. NICHD CRS
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Florida
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Jacksonville, Florida, United States, 32209
- Univ. of Florida Jacksonville NICHD CRS
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Miami, Florida, United States, 33136
- Pediatric Perinatal HIV Clinical Trials Unit CRS
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Tampa, Florida, United States, 33606
- USF - Tampa NICHD CRS
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Georgia
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Atlanta, Georgia, United States, 30322
- Emory University School of Medicine NICHD CRS
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Augusta, Georgia, United States, 30912
- Med. College of Georgia School of Medicine, Dept. of Peds., Div. of Infectious Diseases
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Illinois
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Chicago, Illinois, United States, 60608
- Mt. Sinai Hosp. Med. Ctr. - Chicago, Womens & Childrens HIV Program
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Chicago, Illinois, United States, 60612
- Rush Univ. Cook County Hosp. Chicago NICHD CRS
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Chicago, Illinois, United States, 60614-3393
- Lurie Children's Hospital of Chicago (LCH) CRS
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Chicago, Illinois, United States, 60612
- Univ. of Illinois College of Medicine at Chicago, Dept. of Peds.
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Louisiana
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New Orleans, Louisiana, United States, 70112
- Tulane Univ. New Orleans NICHD CRS
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Maryland
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Baltimore, Maryland, United States, 21201
- Univ. of Maryland Baltimore NICHD CRS
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Baltimore, Maryland, United States, 21287
- Johns Hopkins Univ. Baltimore NICHD CRS
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Massachusetts
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Boston, Massachusetts, United States, 02118
- Boston Medical Center Ped. HIV Program NICHD CRS
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Boston, Massachusetts, United States, 02115
- Children's Hosp. of Boston NICHD CRS
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Springfield, Massachusetts, United States, 01199
- Baystate Health, Baystate Med. Ctr.
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Worcester, Massachusetts, United States, 01605
- WNE Maternal Pediatric Adolescent AIDS CRS
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Michigan
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Detroit, Michigan, United States, 48201
- Children's Hospital of Michigan NICHD CRS
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New Jersey
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Newark, New Jersey, United States, 07103
- Rutgers - New Jersey Medical School CRS
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New York
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Bronx, New York, United States, 10461
- Jacobi Med. Ctr. Bronx NICHD CRS
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Bronx, New York, United States, 10457
- Bronx-Lebanon Hospital Center NICHD CRS
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New York, New York, United States, 10016
- Nyu Ny Nichd Crs
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New York, New York, United States, 10032
- Columbia IMPAACT CRS
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New York, New York, United States, 10029
- Metropolitan Hosp. NICHD CRS
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Stony Brook, New York, United States, 11794
- SUNY Stony Brook NICHD CRS
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North Carolina
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Durham, North Carolina, United States, 27710
- DUMC Ped. CRS
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Philadelphia IMPAACT Unit CRS
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Tennessee
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Memphis, Tennessee, United States, 38105-3678
- St. Jude Children's Research Hospital CRS
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Memphis, Tennessee, United States, 38103
- Regional Med. Ctr. at Memphis
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Washington
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Seattle, Washington, United States, 98101
- Seattle Children's Research Institute CRS
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Maternal Inclusion Criteria:
Participant must belong to one of the following 5 groups:
- HIV-infected pregnant women greater than or equal to 20 weeks gestation NOT on TB treatment receiving one or more of the ARV drugs/drug combinations specified in the protocol
- HIV-infected pregnant women greater than or equal to 20 weeks gestation receiving one of the ARV drugs/drug combinations specified in the protocol and TB treatment with at least one of the TB drugs, specified in the protocol, at study entry
- HIV-uninfected pregnant women greater than or equal to 20 weeks gestation receiving at least two of the first-line TB drugs, specified in the protocol, at study entry
- HIV-infected and HIV-uninfected pregnant women greater than or equal to 20 weeks gestation receiving at least two of the second-line TB drugs, specified in the protocol, at study entry
- HIV-infected women 2 to 12 weeks (14 to 84 days) post-delivery receiving one of the ARV drug combinations listed in the protocol AND starting postpartum contraceptives as listed in the protocol
- The woman must be stable on the ARV drug/drug combination and/or TB drug combination for at least 2 weeks prior to PK sampling
- If a woman is receiving a specific generic ARV formulation, the protocol team has approved this formulation
- HIV-infected pregnant women must be planning to continue on current ARV regimen until postpartum PK sampling is completed. HIV-infected postpartum women on hormonal contraceptives must be planning to continue on ARV and contraceptive regimens until final PK sampling is completed
- For HIV-infected women: confirmed HIV infection, documented by positive results from two samples collected at different time points prior to study entry. More information on this criterion can be found in the protocol.
- HIV-uninfected pregnant women must have documented negative HIV antibody test during current pregnancy. Note: adequate source documentation, including the date of specimen collection, date of testing, test performed, and test result, must be available.
- Participants enrolling in the 3rd trimester must enroll by 37 6/7 weeks gestation
- Participant can provide legal informed consent per local regulations
- If a woman has completed this study and becomes pregnant again, she may re-enroll in the study only if she is enrolled in a different arm than that studied during her initial enrollment
Maternal Exclusion Criteria:
- Women on medicines known to interfere with absorption, metabolism, or clearance of the drug being evaluated (see protocol for more information). Rifampicin is permitted for women being evaluated for TB and ARV drug interactions
- If pregnant, carrying multiple fetuses
- Clinical or laboratory toxicity that, in the opinion of the site investigator, would be likely to require a change in the medicine regimen during the period of study
Infant Enrollment Criteria:
- All infants of mothers enrolled during pregnancy (meeting criteria specified above) are enrolled, in utero, immediately after maternal enrollment.
Infant Requirements for Washout Pharmacokinetic Sampling:
- Born to HIV-infected mother enrolled during pregnancy in an ARV arm (does not include infants born to HIV-uninfected mothers receiving TB drugs)
- Birth weight greater than 1000 grams
- Is NOT receiving disallowed medications described in Section 7 of the protocol
- Does not have any severe congenital malformation or other medical condition not compatible with life or that would interfere with study participation or interpretation, as judged by the site investigator
- Born after singleton delivery (not after multiple birth)
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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DRV/RTV 600 or 800 or 900/100mg b.i.d. then 800 or 900/100mg b.i.d. then 600/100mg b.i.d.
HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received: darunavir/ritonavir (DRV/RTV) 600/100 mg twice daily (b.i.d.) or 800/100 mg b.i.d. until 30 weeks gestation; then 800/100 mg b.i.d. until postpartum hospital discharge; then 600/100 mg b.i.d. after postpartum hospital discharge until 2 week postpartum PK samples are drawn. OR darunavir/ritonavir twice daily 600/100 mg b.i.d. or 900/100 mg b.i.d. until 30 weeks gestation; then 900/100 mg b.i.d. until postpartum hospital discharge; then 600/100 mg b.i.d. after postpartum hospital discharge until 2 week postpartum PK samples are drawn. |
darunavir/ritonavir twice daily 600/100 mg b.i.d.
darunavir/ritonavir twice daily 800/100 mg b.i.d.
darunavir/ritonavir twice daily 900/100 mg b.i.d.
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DTG 50mg q.d.
HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received dolutegravir (DTG) 50 mg once a day (q.d.).
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dolutegravir 50 mg q.d.
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TAF 25mg q.d.
HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received tenofovir alafenamide fumarate (TAF) 25 mg q.d.
without cobicistat or ritonavir boosting.
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TAF 25 mg q.d.
without cobicistat or ritonavir boosting
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TAF 10mg q.d. w/COBI
HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received tenofovir alafenamide fumarate (TAF) 10 mg q.d. with cobicistat (COBI).
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TAF 10 mg q.d. with cobicistat
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TAF 25mg q.d. w/COBI or RTV boosting
HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received tenofovir alafenamide fumarate (TAF) 25 mg q.d. with cobicistat (COBI) or ritonavir (RTV) boosting.
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TAF 25 mg q.d. with cobicistat or ritonavir boosting
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EVG/COBI 150/150mg q.d.
HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received elvitegravir/cobicistat (EVG/COBI) 150/150 mg q.d
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elvitegravir/cobicistat 150/150 mg q.d.
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DRV/COBI 800/150 mg q.d.
HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received darunavir/cobicistat (DRV/COBI) 800/150 mg q.d.
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darunavir/cobicistat 800/150 mg q.d.
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ATV/COBI 300/150 mg q.d.
HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received atazanavir/cobicistat (ATV/COBI) 300/150 mg q.d.
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atazanavir/cobicistat 300/150 mg q.d.
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EFV 600 mg q.d. (outside THA)
HIV-infected pregnant women ≥ 20 weeks gestation NOT on tuberculosis treatment who received efavirenz (EFV) 600 mg q.d.
(Participants outside of Thailand only)
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efavirenz 600 mg q.d.
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EFV 600mg q.d. and at least one 1st line TB drug
HIV-infected pregnant women ≥ 20 weeks gestation who received efavirenz (EFV) 600mg q.d.and TB treatment with at least one of the following TB drugs at study entry:
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efavirenz 600 mg q.d.
rifampicin 8-12 mg/kg (max 600 mg) q.d.; 8-12 mg/kg (max 900 mg) t.i.w.
ethambutol 15-20 mg/kg q.d., 25-35 mg/kg t.i.w.
isoniazid 4-6 mg/kg (max 300 mg) q.d.; 8-12 mg/kg (max 900 mg) t.i.w.
pyrazinamide 20-30mg/kg q.d.; 30-40mg/kg t.i.w.
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LPV/RTV 800/200mg b.i.d. and at least one 1st line TB drug
HIV-infected pregnant women ≥ 20 weeks gestation who received lopinavir/ritonavir (LPV/RTV) 800/200mg b.i.d. and TB treatment with at least one of the following TB drugs at study entry:
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rifampicin 8-12 mg/kg (max 600 mg) q.d.; 8-12 mg/kg (max 900 mg) t.i.w.
ethambutol 15-20 mg/kg q.d., 25-35 mg/kg t.i.w.
isoniazid 4-6 mg/kg (max 300 mg) q.d.; 8-12 mg/kg (max 900 mg) t.i.w.
pyrazinamide 20-30mg/kg q.d.; 30-40mg/kg t.i.w.
lopinavir/ritonavir 800/200mg b.i.d.
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No ARVs and at least two 1st line TB drugs
HIV-uninfected pregnant women ≥ 20 weeks gestation who received at least two of the following first line TB drugs at study entry:
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rifampicin 8-12 mg/kg (max 600 mg) q.d.; 8-12 mg/kg (max 900 mg) t.i.w.
ethambutol 15-20 mg/kg q.d., 25-35 mg/kg t.i.w.
isoniazid 4-6 mg/kg (max 300 mg) q.d.; 8-12 mg/kg (max 900 mg) t.i.w.
pyrazinamide 20-30mg/kg q.d.; 30-40mg/kg t.i.w.
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At least two 2nd line TB drugs w/ or w/out ARVs
HIV-infected and HIV-uninfected pregnant women ≥ 20 weeks gestation who received at least two of the following second line TB drugs at study entry: Injectable agents:
Fluoroquinolones:
Oral bacteriostatic second-line agents:
Other agents:
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kanamycin (2nd line TB drug)
amikacin (2nd line TB drug)
capreomycin (2nd line TB drug)
moxifloxacin (2nd line TB drug)
levofloxacin (2nd line TB drug)
ofloxacin (2nd line TB drug)
ethionamide/prothionamide (2nd line TB drug)
terizidone/cycloserine (2nd line TB drug)
para-aminosalicylic acid (PAS) (2nd line TB drug)
high dose INH (2nd line TB drug)
bedaquiline (2nd line TB drug)
clofazamine (2nd TB drug)
delamanid (2nd line TB drug)
linezolid (2nd line TB drug)
pretomanid (2nd line TB drug)
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DRV/COBI 800/150mg q.d. or ATV/COBI 300/150mg q.d with 30-35ug EE
HIV-infected women 2-12 weeks (14-84 days) post-delivery who received darunavir/cobicistat (DRV/COBI) 800/150 mg q.d. or atazanavir/cobicistat (ATV/COBI) 300/150 mg q.d.
postpartum and starting combined oral contraceptives formulated with 30-35 μg ethinyl estradiol
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darunavir/cobicistat 800/150 mg q.d.
atazanavir/cobicistat 300/150 mg q.d.
oral contraceptives formulated with 30-35 μg ethinyl estradiol
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DRV/COBI 800/150mg q.d. or ATV/COBI 300/150mg q.d with ENG
HIV-infected women 2-12 weeks (14-84 days) post-delivery who received darunavir/cobicistat (DRV/COBI) 800/150 mg q.d. or atazanavir/cobicistat (ATV/COBI) 300/150 mg q.d.
postpartum and starting etonogestrel (ENG) implant
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darunavir/cobicistat 800/150 mg q.d.
atazanavir/cobicistat 300/150 mg q.d.
etonogestrel implant contraceptive
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EFV 600mg q.d. with 30-35ug EE
HIV-infected women 2-12 weeks (14-84 days) post-delivery who received efavirenz (EFV) 600mg q.d.
postpartum and starting combined oral contraceptives formulated with 30-35 μg ethinyl estradiol (EE)
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efavirenz 600 mg q.d.
oral contraceptives formulated with 30-35 μg ethinyl estradiol
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ATV/RTV/TFV 300/100/300mg q.d. with 30-35ug EE
HIV-infected women 2-12 weeks (14-84 days) post-delivery who received atazanavir/ritonavir/tenofovir (ATV/RTV/TFV) 300/100/300 mg q.d.
postpartum and starting combined oral contraceptives formulated with 30-35 μg ethinyl estradiol (EE)
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oral contraceptives formulated with 30-35 μg ethinyl estradiol
atazanavir/ritonavir/tenofovir 300/100/300mg q.d.
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NVP 200mg b.i.d
HIV-infected pregnant women ≥ 26 weeks gestation who received nevirapine (NVP) 200 mg twice a day
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nevirapine 200 mg twice a day
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APV 1200mg b.i.d
HIV-infected pregnant women ≥ 26 weeks gestation who received amprenavir (APV) 1200mg twice a day
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amprenavir 1200mg twice a day
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ABC 300mg b.i.d
HIV-infected pregnant women ≥ 20 weeks gestation who received abacavir (ABC) 300mg twice a day
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abacavir 300mg twice a day
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LPV/RTV Arm 1: 400/100mg b.i.d
HIV-infected pregnant women ≥ 26 weeks gestation who received lopinavir/ritonavir (LPV/RTV) 400/100mg twice a day
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lopinavir/ritonavir (Kaletra) 400/100mg twice a day
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IDV/RTV Arm 1: 800/100mg b.i.d
HIV-infected pregnant women ≥ 26 weeks gestation who received indinavir/ritonavir (IDV/RTV) 800/100 mg twice a day
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indinavir/ritonavir 800/100mg twice a day
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FPV/RTV 700/100mg b.i.d.
HIV-infected pregnant women ≥ 20 weeks gestation who received fosamprenavir/ritonavir (FPV/RTV)700/100mg twice a day
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fosamprenavir/ritonavir 700/100 mg twice a day
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LPV/RTV Arm 2: 400/100mg b.i.d. then 533/133mg b.i.d.
HIV-infected pregnant women ≥ 20 weeks gestation who received Kaletra (LPV/RTV) 400/100 mg twice a day until 30 weeks gestation, then 533/133 mg twice a day until results of postpartum PK evaluation were available
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lopinavir/ritonavir (Kaletra) 400/100mg twice a day
lopinavir/ritonavir (Kaletra) 533/133 mg twice a day
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ATV/RTV Arm 1: 300/100mg q.d.
HIV-infected pregnant women ≥ 20 weeks gestation who received atazanavir/ritonavir (ATV/RTV) 300/100 mg once a day
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atazanavir/ritonavir 300/100 mg once a day
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DDI 400mg or 250mg q.d.
HIV-infected pregnant women ≥ 20 weeks gestation who received didanosine delayed release (Videx® EC) (DDI) 400 mg once a day if weight > 60 kg; 250 mg once a day if weight < 60 kg
|
didanosine delayed release (Videx® EC) 400 mg once a day if weight > 60 kg; 250 mg once a day if weight < 60 kg
|
FTC 200mg q.d.
HIV-infected pregnant women ≥ 20 weeks gestation who received emtricitabine (FTC) 200 mg once a day
|
emtricitabine 200 mg once a day
|
TFV 300mg q.d.
HIV-infected pregnant women ≥ 20 weeks gestation who received tenofovir (TFV) 300 mg once a day
|
tenofovir 300 mg once a day
|
TFV/ATV/RTV Arm 1: 300/300/100mg q.d.
HIV-infected pregnant women ≥ 20 weeks gestation who received tenofovir/atazanavir/ritonavir (TFV/ATV/RTV) 300/300/100 mg once a day
|
atazanavir/ritonavir/tenofovir 300/100/300mg q.d.
|
NFV Arm 1: 1250mg b.i.d.
HIV-infected pregnant women ≥ 20 weeks gestation who received nelfinavir (NFV) [625 mg tablets] 1250 mg twice a day
|
nelfinavir [625 mg tablets] 1250 mg twice a day
|
EFV 600mg q.d.
HIV-infected pregnant women ≥ 20 weeks gestation who received efavirenz (EFV) 600 mg once a day
|
efavirenz 600 mg q.d.
|
TPV/RTV 500/200mg b.i.d.
HIV-infected pregnant women ≥ 20 weeks gestation who received tipranavir/ritonavir (TPV/RTV) 500/200 mg twice a day
|
tipranavir/ritonavir 500/200 mg twice a day
|
LPV/RTV Arm 3: 400/100mg b.i.d. then 600/150mg b.i.d. then 400/100mg b.i.d.
HIV-infected pregnant women ≥ 20 weeks gestation who received lopinavir/ritonavir (LPV/RTV) tablets 400/100 mg [2 tablets] twice a day until 30 weeks gestation, then 600/150 mg [3 tablets] twice a day until postpartum hospital discharge; and 400/100 mg [2 tablets] twice a day after postpartum hospital discharge, until 2 week postpartum PK sample is drawn
|
lopinavir/ritonavir (Kaletra) 400/100mg twice a day
lopinavir/ritonavir (Kaletra) tablets 600/150 mg [3 tablets] twice a day
|
RAL 400mg b.i.d.
HIV-infected pregnant women ≥ 20 weeks gestation who received raltegravir (RAL) 400 mg twice a day
|
raltegravir 400 mg twice a day
|
ETR 200mg b.i.d.
HIV-infected pregnant women ≥ 20 weeks gestation who received etravirine (ETR) 200mg twice a day
|
etravirine 200 mg twice a day
|
MVC 150 or 300mg b.i.d.
HIV-infected pregnant women ≥ 20 weeks gestation who received maraviroc (MVC)150 mg or 300 mg twice a day
|
maraviroc 150 mg or 300 mg twice a day
|
DRV/RTV 800/100mg q.d.
HIV-infected pregnant women ≥ 20 weeks gestation who received darunavir/ritonavir (DRV/RTV) 800/100 mg once a day
|
darunavir/ritonavir once daily 800/100 mg q.d.
|
DRV/RTV 600/100mg b.i.d.
HIV-infected pregnant women ≥ 20 weeks gestation who received darunavir/ritonavir (DRV/RTV) 600/100 mg twice a day
|
darunavir/ritonavir twice daily 600/100 mg b.i.d.
|
ATV/RTV Arm 2: 300/100mg q.d. then 400/100mg q.d. then 300/100mg q.d.
HIV-infected pregnant women ≥ 20 weeks gestation who received atazanavir/ritonavir (ATV/RTV) 300/100 mg once a day until 30 weeks gestation then 400/100 mg once a day until postpartum hospital discharge; then 300/100 mg once a day after postpartum hospital discharge until 2 week postpartum PK samples drawn
|
atazanavir/ritonavir 300/100 mg once a day
atazanavir/ritonavir 400/100mg once a day
|
TFV/ATV/RTV Arm 2: 300/300/100mg q.d. then 300/400/100mg q.d then 300/300/100mg q.d.
HIV-infected pregnant women ≥ 20 weeks gestation who received tenofovir/atazanavir/ritonavir (TFV/ATV/RTV) 300/300/100 mg once a day until 30 weeks gestation; then 300/400/100 mg once a day until postpartum hospital discharge; then 300/300/100 mg once a day after postpartum hospital discharge until 2 week postpartum PK samples drawn
|
atazanavir/ritonavir/tenofovir 300/100/300mg q.d.
tenofovir/atazanavir/ritonavir 300/400/100 mg once a day
|
NFV Arm 2: 1250mg b.i.d. then 1875mg b.i.d. then 1250mg b.i.d.
HIV-infected pregnant women ≥ 20 weeks gestation who received nelfinavir (NFV) [625 mg tablets] 1250 mg twice a day until 30 weeks gestation; then 1875 mg twice a day until postpartum hospital discharge; then 1250 mg twice a day after postpartum hospital discharge until 2 week postpartum PK samples drawn
|
nelfinavir [625 mg tablets] 1250 mg twice a day
nelfinavir [625 mg tablets] 1875 mg twice a day
|
IDV/RTV Arm 2: 400/100mg q.d. (only THA)
HIV-infected pregnant women ≥ 20 weeks gestation who received indinavir/ritonavir (IDV/RTV) 400/100 mg twice a day only to participants enrolling in Thailand
|
indinavir/ritonavir 400/100 mg twice a day
|
LPV/RTV Arm 4: 400/100mg b.i.d. then 600/150mg b.i.d. then 400/100mg b.i.d. (only African sites)
HIV-infected pregnant women ≥ 20 weeks gestation who received lopinavir/ritonavir (LPV/RTV, Alluvia tablets) 400/100 mg [2 tablets] twice day until 30 weeks gestation; then 600/150 mg [3 tablets] twice a day until postpartum hospital discharge; then 400/100 mg [2 tablets] twice a day after postpartum hospital discharge until 2 week postpartum PK sample drawn only to participants enrolling in Uganda
|
lopinavir/ritonavir (Kaletra) 400/100mg twice a day
lopinavir/ritonavir (Kaletra) tablets 600/150 mg [3 tablets] twice a day
|
RPV 25mg q.d.
HIV-infected pregnant women ≥ 20 weeks gestation who received rilpivirine (RPV) (25 mg q.d.)
|
rilpivirine (25 mg q.d.)
|
NVP 200mg b.i.d. and RIF and at least one 1st line TB drug
HIV-infected pregnant women > 20 weeks gestation who received nevirapine (NVP) 200 mg b.i.d AND rifampicin 8-12 mg/kg (max 600 mg) q.d.; 8-12 mg/kg (max 900 mg) t.i.w. and at least one of the following drugs at study entry:
|
ethambutol 15-20 mg/kg q.d., 25-35 mg/kg t.i.w.
isoniazid 4-6 mg/kg (max 300 mg) q.d.; 8-12 mg/kg (max 900 mg) t.i.w.
pyrazinamide 20-30mg/kg q.d.; 30-40mg/kg t.i.w.
nevirapine 200 mg twice a day
|
ATV/RTV/TFV 300/100/300mg q.d. with ENG
HIV- infected women 2-12 weeks postpartum who received atazanavir/ritonavir/tenofovir (ATV/RTV/TFV) 300/100/300 mg q.d.
postpartum and starting postpartum etonogestrel (ENG) implant
|
etonogestrel implant contraceptive
atazanavir/ritonavir/tenofovir 300/100/300mg q.d.
|
LPV/RTV 400/100 b.i.d. with 30-35ug EE
HIV- infected women 2-12 weeks postpartum who received lopinavir/ritonavir (LPV/RTV) 400/100 b.i.d.
postpartum and starting combined oral contraceptives formulated with 30-35 μg ethinyl estradiol (EE)
|
oral contraceptives formulated with 30-35 μg ethinyl estradiol
lopinavir/ritonavir (Kaletra) 400/100mg twice a day
|
LPV/RTV 400/100 b.i.d. with ENG
HIV- infected women 2-12 weeks postpartum who received lopinavir/ritonavir (LPV/RTV) 400/100 b.i.d.
postpartum and starting postpartum etonogestrel (ENG) implant
|
etonogestrel implant contraceptive
lopinavir/ritonavir (Kaletra) 400/100mg twice a day
|
EFV 600mg q.d. with ENG
HIV-infected women 2-12 weeks postpartum who received efavirenz (EFV) 600mg q.d.
postpartum and starting postpartum etonogestrel (ENG) implant
|
efavirenz 600 mg q.d.
etonogestrel implant contraceptive
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PK Parameter: Area Under the Curve From 0 to 12 Hours (AUC12) With Median (IQR) for ARVs and TB Drugs
Time Frame: Measured in 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks, or 6-12 wks postpartum depending on study arm. Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, and 12 hrs post dosing.
|
Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods.
AUC12 (area under the curve from 0 to 12 hours) were determined using the linear trapezoidal rule.
|
Measured in 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks, or 6-12 wks postpartum depending on study arm. Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, and 12 hrs post dosing.
|
PK Parameter: Area Under the Curve From 0 to 12 Hours (AUC12) With Median (Range) for ARVs and TB Drugs
Time Frame: Measured in 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks, or 6-12 wks postpartum depending on study arm. Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, and 12 hrs post dosing.
|
Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods.
AUC12 (area under the curve from 0 to 12 hours) were determined using the linear trapezoidal rule.
|
Measured in 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks, or 6-12 wks postpartum depending on study arm. Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, and 12 hrs post dosing.
|
PK Parameter: Area Under the Curve From 0 to 12 Hours (AUC12) With Geometric Mean (95% CI) for ARVs and TB Drugs
Time Frame: Measured in 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks, or 6-12 wks postpartum depending on study arm. Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, and 12 hrs post dosing.
|
Measured in 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks, or 6-12 wks postpartum depending on study arm.
Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, and 12 hrs post dosing.
|
Measured in 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks, or 6-12 wks postpartum depending on study arm. Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, and 12 hrs post dosing.
|
PK Parameter: Area Under the Curve From 0 to 24 Hours (AUC24) With Median (IQR) for ARVs and TB Drugs
Time Frame: Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm. Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, 12 and 24 hours post dosing.
|
Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods.
AUC24 (area under the curve from 0 to 24 hours) were determined using the linear trapezoidal rule.
|
Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm. Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, 12 and 24 hours post dosing.
|
PK Parameter: Area Under the Curve From 0 to 24 Hours (AUC24) With Median (Range) for ARVs and TB Drugs
Time Frame: Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm. Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, 12 and 24 hours post dosing.
|
Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods.
AUC24h (area-under-the-curve from 0 to 24 hours) were determined using the trapezoidal rule.
|
Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm. Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, 12 and 24 hours post dosing.
|
PK Parameter: Maximum Concentration (Cmax) in mg/L With Median (IQR) for ARVs and TB Drugs
Time Frame: Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm; Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8,12 (and 24) hours post dosing.
|
Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods.
Cmax was the maximum observed concentration after a dose.
|
Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm; Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8,12 (and 24) hours post dosing.
|
PK Parameter: Maximum Concentration (Cmax) in mg/L With Median (Range) for ARVs and TB Drugs
Time Frame: Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm; Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8,12 (and 24) hours post dosing.
|
Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods.
Cmax was the maximum observed concentration after a dose.
|
Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm; Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8,12 (and 24) hours post dosing.
|
PK Parameter: Maximum Concentration (Cmax) in ng/mL With Median (IQR) for ARVs and TB Drugs
Time Frame: Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm; Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8,12 (and 24) hours post dosing.
|
Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods.
Cmax was the maximum observed concentration after a dose.
|
Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm; Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8,12 (and 24) hours post dosing.
|
PK Parameter: Maximum Concentration (Cmax) in ng/mL With Median (95% CI) for ARVs and TB Drugs
Time Frame: Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm; Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8,12 (and 24) hours post dosing.
|
Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods.
Cmax was the maximum observed concentration after a dose.
|
Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm; Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8,12 (and 24) hours post dosing.
|
PK Parameter: Trough Concentration (C12) With Median (IQR) for ARVs and TB Drugs
Time Frame: Measured at 2nd trimester (20-26 wks gestation); 3rd trimester (30-38 gestation); and either 2-3 wks, 2-8 wks, or 6-12 wks postpartum, depending on study arm. Trough concentration was measured 12 hrs after an observed dose.
|
Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods.
Trough concentration was the measured concentration from the 12h post-dose sample after an observed dose.
|
Measured at 2nd trimester (20-26 wks gestation); 3rd trimester (30-38 gestation); and either 2-3 wks, 2-8 wks, or 6-12 wks postpartum, depending on study arm. Trough concentration was measured 12 hrs after an observed dose.
|
PK Parameter: Trough Concentration (C12) With Median (Range) for ARVs and TB Drugs
Time Frame: Measured at 2nd trimester (20-26 wks gestation); 3rd trimester (30-38 gestation); and either 2-3 wks, 2-8 wks, or 6-12 wks postpartum, depending on study arm. Trough concentration was measured 12 hrs after an observed dose.
|
Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods.
Trough concentration was the measured concentration from the 12h post-dose sample after an observed dose.
|
Measured at 2nd trimester (20-26 wks gestation); 3rd trimester (30-38 gestation); and either 2-3 wks, 2-8 wks, or 6-12 wks postpartum, depending on study arm. Trough concentration was measured 12 hrs after an observed dose.
|
PK Parameter: Trough Concentration (C12) With Geometric Mean (95% CI) for ARVs and TB Drugs
Time Frame: Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm. Trough concentration was measured 12 hrs after an observed dose.
|
Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods.
Trough concentration was the measured concentration from the 12h post-dose sample after an observed dose.
|
Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm. Trough concentration was measured 12 hrs after an observed dose.
|
PK Parameter: Trough Concentration (C24) With Median (IQR) for ARVs and TB Drugs
Time Frame: Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm. Trough concentration was measured 24 hrs after an observed dose.
|
Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. Trough concentration was the measured concentration from the 24h post-dose sample after an observed dose. For the TAF 25 mg q.d., 10 mg q.d. w/COBI, and 25 mg q.d. w/COBI or RTV boosting arms, samples were all below the limit of quantification and statistical analyses were not conducted. |
Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm. Trough concentration was measured 24 hrs after an observed dose.
|
PK Parameter: Trough Concentration (C24) With Median (Range) for ARVs and TB Drugs
Time Frame: Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm. Trough concentration was measured 24 hrs after an observed dose.
|
Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods.
Trough concentration was the measured concentration from the 24h post-dose sample after an observed dose.
|
Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm. Trough concentration was measured 24 hrs after an observed dose.
|
Number of Women Who Met PK Target of Area Under the Curve (AUC) for ARVs
Time Frame: Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm. Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, 12 (and 24) hours post dosing.
|
Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods.
AUC (area under the curve) were determined using the linear trapezoidal rule.
See PK target in the Protocol Appendix V.
|
Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm. Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, 12 (and 24) hours post dosing.
|
Number of Women Who Met PK Target of Maximum Concentration (Cmax) for First Line TB Drugs
Time Frame: Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm. Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, 12 (and 24) hours post dosing.
|
Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. Cmax was the maximum observed concentration after a dose. See PK target in Protocol Appendix V. No results are available for this outcome measure at this time. The TB drugs are being assayed in batches (not real-time) after the study completion. Labs have been experiencing additional delays due to urgent COVID-19 pandemic related work. |
Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm. Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, 12 (and 24) hours post dosing.
|
Plasma Concentration for Contraceptives
Time Frame: Measured at 6-7 weeks after contraceptive initiation postpartum
|
Serum concentrations of the contraceptives.
Note that no historical controls were provided by team pharmacologists and thus no comparisons were done for contraceptive concentrations in women using hormonal contraceptives and selected ARV drugs as compared to historical controls not using those ARV drugs.
|
Measured at 6-7 weeks after contraceptive initiation postpartum
|
Area Under the Curve From 0 to 12 Hours (AUC12) of ARVs for Contraceptive Arms
Time Frame: Measured at 2-12 wks postpartum before contraceptive initiation and 6-7 wks after contraceptive initiation. Blood samples were drawn pre-dose and at 0, 1, 2, 6, 8 and 12 hours post dosing.
|
Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods.
AUC12h (area-under-the-curve from 0 to 12 hours) were determined using the linear trapezoidal rule.
|
Measured at 2-12 wks postpartum before contraceptive initiation and 6-7 wks after contraceptive initiation. Blood samples were drawn pre-dose and at 0, 1, 2, 6, 8 and 12 hours post dosing.
|
Area Under the Curve From 0 to 24 Hours (AUC24) of ARVs for Contraceptive Arms
Time Frame: Measured at 2-12 wks postpartum before contraceptive initiation and 6-7 wks after contraceptive initiation. Blood samples were drawn pre-dose and at 0, 1, 2, 6, 8, 12, and 24 hours post dosing.
|
Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods.
AUC24h (area-under-the-curve from 0 to 24 hours) were determined using the linear trapezoidal rule.
|
Measured at 2-12 wks postpartum before contraceptive initiation and 6-7 wks after contraceptive initiation. Blood samples were drawn pre-dose and at 0, 1, 2, 6, 8, 12, and 24 hours post dosing.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PK Parameter: Cord/Maternal Blood Concentration Ratio With Median (IQR) for ARVs and TB Drugs
Time Frame: Measured at time of delivery with single cord blood and single maternal plasma sample.
|
Cord blood and maternal plasma concentrations were collected and measured at delivery, and compared as a ratio.
|
Measured at time of delivery with single cord blood and single maternal plasma sample.
|
PK Parameter: Cord/Maternal Blood Concentration Ratio With Median (Range) for ARVs and TB Drugs
Time Frame: Measured at time of delivery with single cord blood and single maternal plasma sample.
|
Cord blood and maternal plasma concentrations were collected and measured at delivery, and compared as a ratio.
For arms with zero overall participants analyzed, samples were below the limit of quantification and ratios could not be calculated.
|
Measured at time of delivery with single cord blood and single maternal plasma sample.
|
Pharmacokinetic (PK) Parameter: Infant Plasma Washout Half-life (T1/2) of ARVs and TB Drugs
Time Frame: Infant plasma samples at 2-10, 18-28, 36-72 hours and 5-9 days after birth.
|
Infant plasma concentrations were collected and measured during the first 9 days of life.
Half-life is defined as 0.693/k, where k, the elimination rate constant, is the slope of the decline in concentrations.
|
Infant plasma samples at 2-10, 18-28, 36-72 hours and 5-9 days after birth.
|
Pharmacokinetic (PK) Parameter: Infant Plasma Washout Concentration of ARVs and TB Drugs
Time Frame: Blood samples were collected at 2-10, 18-28, 36-72 hours and 5-9 days after birth.
|
Infant plasma concentrations were collected and measured during the first 9 days of life.
|
Blood samples were collected at 2-10, 18-28, 36-72 hours and 5-9 days after birth.
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ARV Concentrations in Plasma
Time Frame: Measured at intensive PK visit
|
The original study protocol listed this PK parameter under primary outcome measures.
However, this PK parameter was intended for potential supporting analyses and thus belong with Other outcome measures (see SAP).
|
Measured at intensive PK visit
|
ARV Concentrations in Vaginal Secretions
Time Frame: Measured at intensive PK visit
|
The original study protocol listed this PK parameter under secondary outcome measures.
However, this PK parameter was intended for potential supporting analyses and thus belongs with Other outcome measures (see SAP).
|
Measured at intensive PK visit
|
Drug Parameter: Half-life (t1/2)
Time Frame: Measured at intensive PK visit. Timing of intensive PK visit depends on participant's study arm; may occur during 2nd trimester (20-26 wks gestation); 3rd trimester (30-38 wks gestation); and either 2-3 wks, 2-8 wks, or 6-12 wks postpartum.
|
The original study protocol listed this PK parameter under primary outcome measures.
However, this PK parameter was intended for potential supporting analyses and thus belongs with Other outcome measures (see SAP).
|
Measured at intensive PK visit. Timing of intensive PK visit depends on participant's study arm; may occur during 2nd trimester (20-26 wks gestation); 3rd trimester (30-38 wks gestation); and either 2-3 wks, 2-8 wks, or 6-12 wks postpartum.
|
Drug Parameter: Volume of Distribution Over Systemic Availability (V/F)
Time Frame: Measured at intensive PK visit. Timing of intensive PK visit depends on participant's study arm; may occur during 2nd trimester (20-26 wks gestation); 3rd trimester (30-38 wks gestation); and either 2-3 weeks, 2-8 wks, or 6-12 wks postpartum.
|
The original study protocol listed this PK parameter under primary outcome measures.
However, this PK parameter was intended for potential supporting analyses and thus belongs with Other outcome measures (see SAP).
|
Measured at intensive PK visit. Timing of intensive PK visit depends on participant's study arm; may occur during 2nd trimester (20-26 wks gestation); 3rd trimester (30-38 wks gestation); and either 2-3 weeks, 2-8 wks, or 6-12 wks postpartum.
|
Drug Parameter: Clearance Over Systemic Availability (Cl/F)
Time Frame: Measured at intensive PK visit. Timing of intensive PK visit depends on participant's study arm; may occur during 2nd trimester (20-26 wks gestation); 3rd trimester (30-38 wks gestation); and either 2-3 wks, 2-8 wks, or 6-12 wks postpartum.
|
The original study protocol listed this PK parameter under primary outcome measures.
However, this PK parameter was intended for potential supporting analyses and thus belongs with Other outcome measures (see SAP).
|
Measured at intensive PK visit. Timing of intensive PK visit depends on participant's study arm; may occur during 2nd trimester (20-26 wks gestation); 3rd trimester (30-38 wks gestation); and either 2-3 wks, 2-8 wks, or 6-12 wks postpartum.
|
Drug Parameter: Time After Administration of Drug When Maximum Plasma Concentration is Reached (Tmax)
Time Frame: Measured at intensive PK visit. Timing of intensive PK visit depends on participant's study arm; may occur during 2nd trimester (20-26 wks gestation); 3rd trimester (30-38 wks gestation); and either 2-3 wks, 2-8 wks, or 6-12 wks postpartum.
|
The original study protocol listed this PK parameter under primary outcome measures.
However, this PK parameter was intended for potential supporting analyses and thus belongs with Other outcome measures (see SAP).
|
Measured at intensive PK visit. Timing of intensive PK visit depends on participant's study arm; may occur during 2nd trimester (20-26 wks gestation); 3rd trimester (30-38 wks gestation); and either 2-3 wks, 2-8 wks, or 6-12 wks postpartum.
|
Drug Parameter: Minimum Concentration (Cmin)
Time Frame: Measured at intensive PK visit. Timing of intensive PK visit depends on participant's study arm; may occur during 2nd trimester (20-26 wks gestation); 3rd trimester (30-38 wks gestation); and either 2-3 weeks, 2-8 wks, or 6-12 wks postpartum.
|
The original study protocol listed this PK parameter under primary outcome measures.
However, this PK parameter was intended for potential supporting analyses and thus belongs with Other outcome measures (see SAP).
|
Measured at intensive PK visit. Timing of intensive PK visit depends on participant's study arm; may occur during 2nd trimester (20-26 wks gestation); 3rd trimester (30-38 wks gestation); and either 2-3 weeks, 2-8 wks, or 6-12 wks postpartum.
|
Drug Parameter: Pre-dose Concentration (Cdose)
Time Frame: Measured at intensive PK visit. Timing of intensive PK visit depends on participant's study arm; may occur during 2nd trimester (20-26 wks gestation); 3rd trimester (30-38 wks gestation); and either 2-3 wks, 2-8 wks, or 6-12 wks postpartum.
|
The original study protocol listed this PK parameter under primary outcome measures.
However, this PK parameter was intended for potential supporting analyses and thus belongs with Other outcome measures (see SAP).
|
Measured at intensive PK visit. Timing of intensive PK visit depends on participant's study arm; may occur during 2nd trimester (20-26 wks gestation); 3rd trimester (30-38 wks gestation); and either 2-3 wks, 2-8 wks, or 6-12 wks postpartum.
|
Adverse Events of Grade 3 or Higher
Time Frame: Measured through 24 weeks postpartum
|
The original study protocol listed all non-primary outcome measures under secondary outcome measures without distinguishing between secondary vs other outcome measures. This outcome measure was intended for potential supporting analyses which were not conducted (see SAP). See Adverse events section for adverse events. |
Measured through 24 weeks postpartum
|
Infant Neurological Events of Grade 1 or Higher
Time Frame: Measured through 24 weeks of life
|
The original study protocol listed all non-primary outcome measures under secondary outcome measures without distinguishing between secondary vs other outcome measures. This outcome measure was intended for potential supporting analyses which were not conducted (see SAP). See Adverse events section for adverse events. |
Measured through 24 weeks of life
|
Adverse Pregnancy Outcome: Preterm Birth
Time Frame: Measured through delivery
|
The original study protocol listed all non-primary outcome measures under secondary outcome measures without distinguishing between secondary vs other outcome measures. This outcome measure was intended for potential supporting analyses which were not conducted (see SAP). See Adverse events section for adverse events. |
Measured through delivery
|
Adverse Pregnancy Outcome: Low Birth Weight
Time Frame: Measured at delivery
|
The original study protocol listed all non-primary outcome measures under secondary outcome measures without distinguishing between secondary vs other outcome measures. This outcome measure was intended for potential supporting analyses which were not conducted (see SAP). See Adverse events section for adverse events. |
Measured at delivery
|
Adverse Pregnancy Outcome: Fetal Demise
Time Frame: Measured through 24 weeks postpartum
|
The original study protocol listed all non-primary outcome measures under secondary outcome measures without distinguishing between secondary vs other outcome measures. This outcome measure was intended for potential supporting analyses which were not conducted (see SAP). See Adverse events section for adverse events. |
Measured through 24 weeks postpartum
|
Adverse Pregnancy Outcome: Congenital Anomalies
Time Frame: Measured through 24 weeks of life
|
The original study protocol listed all non-primary outcome measures under secondary outcome measures without distinguishing between secondary vs other outcome measures. This outcome measure was intended for potential supporting analyses which werenot conducted (see SAP). See Adverse events section for adverse events. |
Measured through 24 weeks of life
|
Infant HIV Infection Status
Time Frame: Measured through 24 weeks of life
|
The original study protocol listed all non-primary outcome measures under secondary outcome measures without distinguishing between secondary vs other outcome measures.
This outcome measure was intended for potential supporting analyses which were not conducted (see SAP).
|
Measured through 24 weeks of life
|
Ratio of Unbound/Total Drug Concentrations
Time Frame: Measured at time of delivery
|
The original study protocol listed all non-primary outcome measures under secondary outcome measures without distinguishing between secondary vs other outcome measures.
This outcome measure was intended for potential supporting analyses which were not conducted (see SAP).
|
Measured at time of delivery
|
Rate of Detection of Study Drugs in Vaginal Secretions
Time Frame: Measured at intensive PK visit
|
The original study protocol listed all non-primary outcome measures under secondary outcome measures without distinguishing between secondary vs other outcome measures.
This outcome measure was intended for potential supporting analyses which were not conducted (see SAP).
|
Measured at intensive PK visit
|
Ratio of Vaginal Drug Concentrations to Simultaneous Blood Concentrations
Time Frame: Measured at intensive PK visit
|
The original study protocol listed all non-primary outcome measures under secondary outcome measures without distinguishing between secondary vs other outcome measures.
This outcome measure was intended for potential supporting analyses which were not conducted (see SAP).
|
Measured at intensive PK visit
|
Rate of Detection of HIV RNA/DNA in Vaginal Secretions and Comparison to Level in Blood
Time Frame: Measured at intensive PK visit
|
The original study protocol listed all non-primary outcome measures under secondary outcome measures without distinguishing between secondary vs other outcome measures.
This outcome measure was intended for potential supporting analyses which were not conducted (see SAP).
|
Measured at intensive PK visit
|
ARV Exposure (as Measured by Area Under the Curve or Other PK Parameters) During Pregnancy and Postpartum According to Genotype
Time Frame: Measured at intensive PK visit
|
The original study protocol listed all non-primary outcome measures under secondary outcome measures without distinguishing between secondary vs other outcome measures.
This outcome measure was intended for potential supporting analyses which were not conducted (see SAP).
|
Measured at intensive PK visit
|
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Mark Mirochnick, MD, Boston Medical Center
Publications and helpful links
General Publications
- Loutfy MR, Walmsley SL. Treatment of HIV infection in pregnant women: antiretroviral management options. Drugs. 2004;64(5):471-88. doi: 10.2165/00003495-200464050-00002.
- Mirochnick M, Capparelli E. Pharmacokinetics of antiretrovirals in pregnant women. Clin Pharmacokinet. 2004;43(15):1071-87. doi: 10.2165/00003088-200443150-00002.
- Rakhmanina NY, van den Anker JN, Soldin SJ. Safety and pharmacokinetics of antiretroviral therapy during pregnancy. Ther Drug Monit. 2004 Apr;26(2):110-5. doi: 10.1097/00007691-200404000-00004.
- Sullivan JL. Prevention of mother-to-child transmission of HIV--what next? J Acquir Immune Defic Syndr. 2003 Sep;34 Suppl 1:S67-72. doi: 10.1097/00126334-200309011-00010.
- Best BM, Mirochnick M, Capparelli EV, Stek A, Burchett SK, Holland DT, Read JS, Smith E, Hu C, Spector SA, Connor JD; PACTG P1026s Study Team. Impact of pregnancy on abacavir pharmacokinetics. AIDS. 2006 Feb 28;20(4):553-60. doi: 10.1097/01.aids.0000210609.52836.d1.
- Stek AM, Mirochnick M, Capparelli E, Best BM, Hu C, Burchett SK, Elgie C, Holland DT, Smith E, Tuomala R, Cotter A, Read JS. Reduced lopinavir exposure during pregnancy. AIDS. 2006 Oct 3;20(15):1931-9. doi: 10.1097/01.aids.0000247114.43714.90.
- Aweeka FT, Stek A, Best BM, Hu C, Holland D, Hermes A, Burchett SK, Read J, Mirochnick M, Capparelli EV; International Maternal Pediatric Adolescent AIDS Clinical Trials Group (IMPAACT) P1026s Protocol Team. Lopinavir protein binding in HIV-1-infected pregnant women. HIV Med. 2010 Apr;11(4):232-8. doi: 10.1111/j.1468-1293.2009.00767.x. Epub 2009 Dec 3.
- Mirochnick M, Best BM, Stek AM, Capparelli EV, Hu C, Burchett SK, Rossi SS, Hawkins E, Basar M, Smith E, Read JS; IMPAACT 1026s Study Team. Atazanavir pharmacokinetics with and without tenofovir during pregnancy. J Acquir Immune Defic Syndr. 2011 Apr 15;56(5):412-9. doi: 10.1097/QAI.0b013e31820fd093.
- Capparelli EV, Aweeka F, Hitti J, Stek A, Hu C, Burchett SK, Best B, Smith E, Read JS, Watts H, Nachman S, Thorpe EM Jr, Spector SA, Jimenez E, Shearer WT, Foca M, Mirochnick M; PACTG 1026S Study Team; PACTG P1022 Study Team. Chronic administration of nevirapine during pregnancy: impact of pregnancy on pharmacokinetics. HIV Med. 2008 Apr;9(4):214-20. doi: 10.1111/j.1468-1293.2008.00553.x.
- Mirochnick M, Best BM, Stek AM, Capparelli E, Hu C, Burchett SK, Holland DT, Smith E, Gaddipati S, Read JS; PACTG 1026s Study Team. Lopinavir exposure with an increased dose during pregnancy. J Acquir Immune Defic Syndr. 2008 Dec 15;49(5):485-91. doi: 10.1097/QAI.0b013e318186edd0.
- Read JS, Best BM, Stek AM, Hu C, Capparelli EV, Holland DT, Burchett SK, Smith ME, Sheeran EC, Shearer WT, Febo I, Mirochnick M. Pharmacokinetics of new 625 mg nelfinavir formulation during pregnancy and postpartum. HIV Med. 2008 Nov;9(10):875-82. doi: 10.1111/j.1468-1293.2008.00640.x. Epub 2008 Sep 14.
- Best BM, Stek AM, Mirochnick M, Hu C, Li H, Burchett SK, Rossi SS, Smith E, Read JS, Capparelli EV; International Maternal Pediatric Adolescent AIDS Clinical Trials Group 1026s Study Team. Lopinavir tablet pharmacokinetics with an increased dose during pregnancy. J Acquir Immune Defic Syndr. 2010 Aug;54(4):381-8. doi: 10.1097/qai.0b013e3181d6c9ed.
- Stek AM, Best BM, Luo W, Capparelli E, Burchett S, Hu C, Li H, Read JS, Jennings A, Barr E, Smith E, Rossi SS, Mirochnick M. Effect of pregnancy on emtricitabine pharmacokinetics. HIV Med. 2012 Apr;13(4):226-35. doi: 10.1111/j.1468-1293.2011.00965.x. Epub 2011 Nov 30.
- Cressey TR, Stek A, Capparelli E, Bowonwatanuwong C, Prommas S, Sirivatanapa P, Yuthavisuthi P, Neungton C, Huo Y, Smith E, Best BM, Mirochnick M; IMPAACT P1026s Team. Efavirenz pharmacokinetics during the third trimester of pregnancy and postpartum. J Acquir Immune Defic Syndr. 2012 Mar 1;59(3):245-52. doi: 10.1097/QAI.0b013e31823ff052.
- Cressey TR, Best BM, Achalapong J, Stek A, Wang J, Chotivanich N, Yuthavisuthi P, Suriyachai P, Prommas S, Shapiro DE, Watts DH, Smith E, Capparelli E, Kreitchmann R, Mirochnick M; IMPAACT P1026s team. Reduced indinavir exposure during pregnancy. Br J Clin Pharmacol. 2013 Sep;76(3):475-83. doi: 10.1111/bcp.12078.
- Kreitchmann R, Best BM, Wang J, Stek A, Caparelli E, Watts DH, Smith E, Shapiro DE, Rossi S, Burchett SK, Hawkins E, Byroads M, Cressey TR, Mirochnick M. Pharmacokinetics of an increased atazanavir dose with and without tenofovir during the third trimester of pregnancy. J Acquir Immune Defic Syndr. 2013 May 1;63(1):59-66. doi: 10.1097/QAI.0b013e318289b4d2.
- Watts DH, Stek A, Best BM, Wang J, Capparelli EV, Cressey TR, Aweeka F, Lizak P, Kreitchmann R, Burchett SK, Shapiro DE, Hawkins E, Smith E, Mirochnick M; IMPAACT 1026s study team. Raltegravir pharmacokinetics during pregnancy. J Acquir Immune Defic Syndr. 2014 Dec 1;67(4):375-81. doi: 10.1097/QAI.0000000000000318.
- Cressey TR, Urien S, Capparelli EV, Best BM, Buranabanjasatean S, Limtrakul A, Rawangban B, Sabsanong P, Treluyer JM, Jourdain G, Stek A, Lallemant M, Mirochnick M. Impact of body weight and missed doses on lopinavir concentrations with standard and increased lopinavir/ritonavir doses during late pregnancy. J Antimicrob Chemother. 2015 Jan;70(1):217-24. doi: 10.1093/jac/dku367. Epub 2014 Sep 25.
- Aweeka FT, Hu C, Huang L, Best BM, Stek A, Lizak P, Burchett SK, Read JS, Watts H, Mirochnick M, Capparelli EV; International Maternal Pediatric Adolescent AIDS Clinical Trials Group (IMPAACT) P1026s Protocol Team. Alteration in cytochrome P450 3A4 activity as measured by a urine cortisol assay in HIV-1-infected pregnant women and relationship to antiretroviral pharmacokinetics. HIV Med. 2015 Mar;16(3):176-83. doi: 10.1111/hiv.12195. Epub 2014 Nov 18.
- Colbers A, Best B, Schalkwijk S, Wang J, Stek A, Hidalgo Tenorio C, Hawkins D, Taylor G, Kreitchmann R, Burchett S, Haberl A, Kabeya K, van Kasteren M, Smith E, Capparelli E, Burger D, Mirochnick M; PANNA Network and the IMPAACT 1026 Study Team. Maraviroc Pharmacokinetics in HIV-1-Infected Pregnant Women. Clin Infect Dis. 2015 Nov 15;61(10):1582-9. doi: 10.1093/cid/civ587. Epub 2015 Jul 22.
- Best BM, Burchett S, Li H, Stek A, Hu C, Wang J, Hawkins E, Byroads M, Watts DH, Smith E, Fletcher CV, Capparelli EV, Mirochnick M; International Maternal Pediatric and Adolescent AIDS Clinical Trials (IMPAACT) P1026s Team. Pharmacokinetics of tenofovir during pregnancy and postpartum. HIV Med. 2015 Sep;16(8):502-11. doi: 10.1111/hiv.12252. Epub 2015 May 11.
- Stek A, Best BM, Wang J, Capparelli EV, Burchett SK, Kreitchmann R, Rungruengthanakit K, Cressey TR, Mofenson LM, Smith E, Shapiro D, Mirochnick M. Pharmacokinetics of Once Versus Twice Daily Darunavir in Pregnant HIV-Infected Women. J Acquir Immune Defic Syndr. 2015 Sep 1;70(1):33-41. doi: 10.1097/QAI.0000000000000668.
- Tran AH, Best BM, Stek A, Wang J, Capparelli EV, Burchett SK, Kreitchmann R, Rungruengthanakit K, George K, Cressey TR, Chakhtoura N, Smith E, Shapiro DE, Mirochnick M; IMPAACT P1026s Protocol Team. Pharmacokinetics of Rilpivirine in HIV-Infected Pregnant Women. J Acquir Immune Defic Syndr. 2016 Jul 1;72(3):289-96. doi: 10.1097/QAI.0000000000000968.
- Mulligan N, Schalkwijk S, Best BM, Colbers A, Wang J, Capparelli EV, Molto J, Stek AM, Taylor G, Smith E, Hidalgo Tenorio C, Chakhtoura N, van Kasteren M, Fletcher CV, Mirochnick M, Burger D. Etravirine Pharmacokinetics in HIV-Infected Pregnant Women. Front Pharmacol. 2016 Aug 4;7:239. doi: 10.3389/fphar.2016.00239. eCollection 2016.
- Mulligan N, Best BM, Wang J, Capparelli EV, Stek A, Barr E, Buschur SL, Acosta EP, Smith E, Chakhtoura N, Burchett S, Mirochnick M; IMPAACT P1026s Protocol Team. Dolutegravir pharmacokinetics in pregnant and postpartum women living with HIV. AIDS. 2018 Mar 27;32(6):729-737. doi: 10.1097/QAD.0000000000001755.
- Schalkwijk S, Ter Heine R, Colbers AC, Huitema ADR, Denti P, Dooley KE, Capparelli E, Best BM, Cressey TR, Greupink R, Russel FGM, Mirochnick M, Burger DM. A Mechanism-Based Population Pharmacokinetic Analysis Assessing the Feasibility of Efavirenz Dose Reduction to 400 mg in Pregnant Women. Clin Pharmacokinet. 2018 Nov;57(11):1421-1433. doi: 10.1007/s40262-018-0642-9.
- Eke AC, Chakhtoura N, Kashuba A, Best BM, Sykes C, Wang J, Stek AM, Smith E, Calabrese S, Capparelli EV, Mirochnick M; IMPAACT P1026s Protocol Team. Rilpivirine Plasma and Cervicovaginal Concentrations in Women During Pregnancy and Postpartum. J Acquir Immune Defic Syndr. 2018 Jul 1;78(3):308-313. doi: 10.1097/QAI.0000000000001677.
- Momper JD, Best BM, Wang J, Capparelli EV, Stek A, Barr E, Badell ML, Acosta EP, Purswani M, Smith E, Chakhtoura N, Park K, Burchett S, Shapiro DE, Mirochnick M; IMPAACT P1026s Protocol Team. Elvitegravir/cobicistat pharmacokinetics in pregnant and postpartum women with HIV. AIDS. 2018 Nov 13;32(17):2507-2516. doi: 10.1097/QAD.0000000000001992.
- Eke AC, McCormack SA, Best BM, Stek AM, Wang J, Kreitchmann R, Shapiro D, Smith E, Mofenson LM, Capparelli EV, Mirochnick M; IMPAACT P1026s Protocol Team. Pharmacokinetics of Increased Nelfinavir Plasma Concentrations in Women During Pregnancy and Postpartum. J Clin Pharmacol. 2019 Mar;59(3):386-393. doi: 10.1002/jcph.1331. Epub 2018 Oct 25.
- Kreitchmann R, Schalkwijk S, Best B, Wang J, Colbers A, Stek A, Shapiro D, Cressey T, Mirochnick M, Burger D. Efavirenz pharmacokinetics during pregnancy and infant washout. Antivir Ther. 2019;24(2):95-103. doi: 10.3851/IMP3283.
- Schalkwijk S, Ter Heine R, Colbers A, Capparelli E, Best BM, Cressey TR, Greupink R, Russel FGM, Molto J, Mirochnick M, Karlsson MO, Burger DM. Evaluating darunavir/ritonavir dosing regimens for HIV-positive pregnant women using semi-mechanistic pharmacokinetic modelling. J Antimicrob Chemother. 2019 May 1;74(5):1348-1356. doi: 10.1093/jac/dky567.
- Liu XI, Momper JD, Rakhmanina N, van den Anker JN, Green DJ, Burckart GJ, Best BM, Mirochnick M, Capparelli EV, Dallmann A. Physiologically Based Pharmacokinetic Models to Predict Maternal Pharmacokinetics and Fetal Exposure to Emtricitabine and Acyclovir. J Clin Pharmacol. 2020 Feb;60(2):240-255. doi: 10.1002/jcph.1515. Epub 2019 Sep 6.
- Eke AC, Wang J, Amin K, Shapiro DE, Stek A, Smith E, Chakhtoura N, Basar M, George K, Knapp KM, Joao EC, Rungruengthanakit K, Capparelli E, Burchett S, Mirochnick M, Best BM; P1026s Protocol Team. Fosamprenavir with Ritonavir Pharmacokinetics during Pregnancy. Antimicrob Agents Chemother. 2020 Mar 24;64(4):e02260-19. doi: 10.1128/AAC.02260-19. Print 2020 Mar 24.
- Liu XI, Momper JD, Rakhmanina NY, Green DJ, Burckart GJ, Cressey TR, Mirochnick M, Best BM, van den Anker JN, Dallmann A. Prediction of Maternal and Fetal Pharmacokinetics of Dolutegravir and Raltegravir Using Physiologically Based Pharmacokinetic Modeling. Clin Pharmacokinet. 2020 Nov;59(11):1433-1450. doi: 10.1007/s40262-020-00897-9.
- Brooks KM, Momper JD, Pinilla M, Stek AM, Barr E, Weinberg A, Deville JG, Febo IL, Cielo M, George K, Denson K, Rungruengthanakit K, Shapiro DE, Smith E, Chakhtoura N, Rooney JF, Haubrich R, Espina R, Capparelli EV, Mirochnick M, Best BM; IMPAACT P1026s Protocol Team. Pharmacokinetics of tenofovir alafenamide with and without cobicistat in pregnant and postpartum women living with HIV. AIDS. 2021 Mar 1;35(3):407-417. doi: 10.1097/QAD.0000000000002767.
- Eke AC, Shoji K, Best BM, Momper JD, Stek AM, Cressey TR, Mirochnick M, Capparelli EV. Population Pharmacokinetics of Tenofovir in Pregnant and Postpartum Women Using Tenofovir Disoproxil Fumarate. Antimicrob Agents Chemother. 2021 Feb 17;65(3):e02168-20. doi: 10.1128/AAC.02168-20. Print 2021 Feb 17.
- Momper JD, Wang J, Stek A, Shapiro DE, Scott GB, Paul ME, Febo IL, Burchett S, Smith E, Chakhtoura N, Denson K, Rungruengthanakit K, George K, Yang DZ, Capparelli EV, Mirochnick M, Best BM; IMPAACT P1026s Protocol Team. Pharmacokinetics of darunavir and cobicistat in pregnant and postpartum women with HIV. AIDS. 2021 Jul 1;35(8):1191-1199. doi: 10.1097/QAD.0000000000002857.
- Momper JD, Wang J, Stek A, Shapiro DE, Powis KM, Paul ME, Badell ML, Browning R, Chakhtoura N, Denson K, Rungruengthanakit K, George K, Capparelli EV, Mirochnick M, Best BM; IMPAACT P1026s Protocol Team. Pharmacokinetics of Atazanavir Boosted With Cobicistat in Pregnant and Postpartum Women With HIV. J Acquir Immune Defic Syndr. 2022 Mar 1;89(3):303-309. doi: 10.1097/QAI.0000000000002856.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- HIV Infections
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Reverse Transcriptase Inhibitors
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Anti-Inflammatory Agents
- Antimetabolites
- Antineoplastic Agents
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Protease Inhibitors
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Estrogens
- Hypolipidemic Agents
- Lipid Regulating Agents
- Anti-Bacterial Agents
- Cytochrome P-450 CYP3A Inhibitors
- Cytochrome P-450 Enzyme Inhibitors
- Leprostatic Agents
- Protein Synthesis Inhibitors
- Cytochrome P-450 Enzyme Inducers
- Contraceptive Agents, Hormonal
- Contraceptive Agents
- Reproductive Control Agents
- Contraceptives, Oral
- Contraceptive Agents, Female
- Cytochrome P-450 CYP3A Inducers
- HIV Integrase Inhibitors
- Integrase Inhibitors
- HIV Protease Inhibitors
- Viral Protease Inhibitors
- Antitubercular Agents
- Contraceptives, Oral, Hormonal
- Antibiotics, Antitubercular
- Cytochrome P-450 CYP2B6 Inducers
- Cytochrome P-450 CYP2C8 Inducers
- Cytochrome P-450 CYP2C19 Inducers
- Cytochrome P-450 CYP2C9 Inducers
- Cytochrome P-450 CYP1A2 Inhibitors
- Cytochrome P-450 CYP2C9 Inhibitors
- HIV Fusion Inhibitors
- Viral Fusion Protein Inhibitors
- CCR5 Receptor Antagonists
- Anti-Infective Agents, Urinary
- Renal Agents
- Cytochrome P-450 CYP2C19 Inhibitors
- Fatty Acid Synthesis Inhibitors
- Tenofovir
- Emtricitabine
- Cobicistat
- Linezolid
- Moxifloxacin
- Nevirapine
- Raltegravir Potassium
- Ritonavir
- Lopinavir
- Estradiol
- Indinavir
- Ethinyl Estradiol
- Rifampin
- Maraviroc
- Tipranavir
- Didanosine
- Ofloxacin
- Nelfinavir
- Darunavir
- Etravirine
- Cycloserine
- Atazanavir Sulfate
- Efavirenz
- Bedaquiline
- Dolutegravir
- Rilpivirine
- Abacavir
- Amikacin
- Isoniazid
- Pyrazinamide
- Ethambutol
- Clofazimine
- Aminosalicylic Acid
- Ethionamide
- Kanamycin
- Capreomycin
- Fosamprenavir
- Amprenavir
- Etonogestrel
- Elvitegravir
- Prothionamide
- Cobicistat mixture with darunavir
Other Study ID Numbers
- P1026s
- 10040 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium)
- IMPAACT P1026s
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