Prenatal and Postnatal Studies of Interventions for Prevention of Mother-To-Child Transmission
8 oktober 2014 uppdaterad av: International Maternal Pediatric Adolescent AIDS Clinical Trials Group
Perinatal Core Protocol
The purpose of this study is to collect and study clinical and laboratory information about a pregnant or new mother and her medical care that will increase our knowledge of the best care for HIV-infected pregnant women and their children.
The rate of transmission of HIV from mothers to their infants has gone down. Specific U.S. Public Health Service guidelines recommend that HIV-infected pregnant women be treated with anti-HIV therapies; but the effectiveness of treatment and safety for the mother and her infant have not been fully examined. This study will monitor the health of women and their infants while they receive anti-HIV therapy. Also, this study will provide information that may be used for future studies.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
The current low rate of vertical transmission of HIV in the U.S. limits the number and types of questions concerning transmission risk and pathogenesis that can be addressed by a single clinical trial. Specific U.S. Public Health Service guidelines recommend antiretroviral therapy (ART) during pregnancy to maximize health of women. However, data regarding the effectiveness and safety of and adherence to ART during pregnancy are limited. It is both appropriate and necessary for theInternational Maternal Pediatric Adolescent AIDS Clinical Trials Group (IMPAACT) to recruit pregnant women into a non-interventional, analytic, epidemiologic study to methodically collect clinical and laboratory data from them and their infants. This way, the IMPAACT can achieve the aims of evaluating management of HIV-infected women during pregnancy and determining the safety and effectiveness of ART and other interventions intended to prevent vertical transmission and/or improve maternal health. In addition, longitudinally collected core protocol data and repository specimens will enable future substudies.
Participants receive no protocol specific treatment or other intervention as part of this study. The study involves the follow-up of HIV-infected women enrolled during pregnancy or at the time of delivery for 6 months postpartum and their infants for the first 6 months of life. There will be 8 study visits for enrolled participants and 6 study visits for infants. Data concerning ART use, adherence to medications, and review of symptoms relevant to side effects and toxicities are collected through administration of questionnaires at all maternal visits. Phlebotomy is conducted to obtain specimens for a repository and for required laboratory tests. During labor and delivery, maternal blood is obtained for lymphocyte subset and viral load assays and for repository storage. Collection of amniotic fluid at the time of cesarean section is encouraged. These collections are submitted to a central repository. Data for the core protocol are abstracted from the infant's medical record at the time of birth and at each postnatal visit.
Studietyp
Observationell
Inskrivning (Faktisk)
3090
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Alabama
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Birmingham, Alabama, Förenta staterna, 35233
- Univ. of Alabama Birmingham NICHD CRS (5096)
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Mobile, Alabama, Förenta staterna, 36688
- University of South Alabama
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Arizona
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Phoenix, Arizona, Förenta staterna, 85006
- Phoenix Childrens Hospital
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California
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Long Beach, California, Förenta staterna, 90801
- Long Beach Memorial (Pediatric)
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Long Beach, California, Förenta staterna, 90806
- Miller Children's Hospital Long Beach (5093)
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Los Angeles, California, Förenta staterna, 900951752
- UCLA Med Ctr / Pediatric
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Los Angeles, California, Förenta staterna, 90033
- Usc La Nichd Crs (5048)
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Los Angeles, California, Förenta staterna, 90095
- UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CR (3601)
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Los Angeles, California, Förenta staterna, 90033
- Los Angeles County Medical Center/USC
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San Diego, California, Förenta staterna, 92103
- Univ of California, San Diego (4601)
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San Francisco, California, Förenta staterna, 94117
- Univ. of California San Francisco NICHD CRS (5091)
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Torrance, California, Förenta staterna, 90509
- Harbor-UCLA Med Ctr (5045)
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Colorado
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Denver, Colorado, Förenta staterna, 80218-1088
- University of Colorado Denver NICHD CRS (5052)
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Connecticut
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Farmington, Connecticut, Förenta staterna, 06030-3805
- Connecticut Childrens Medical Center (Pediatric)
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Farmington, Connecticut, Förenta staterna, 06030-3805
- University of Connecticut, Farmington
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New Haven, Connecticut, Förenta staterna, 06504
- Yale Univ School of Med
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District of Columbia
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Washington, District of Columbia, Förenta staterna, 20010-2970
- Children's National Medical Center Washington DC NICHD CRS (5015)
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Washington, District of Columbia, Förenta staterna, 200102931
- Washington Hospital Center NICHD CRS (5023)
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Washington, District of Columbia, Förenta staterna, 20060
- Howard Univ Hosp (5044)
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Florida
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Fort Lauderdale, Florida, Förenta staterna, 33311
- North Broward Hosp District
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Ft Lauderdal, Florida, Förenta staterna, 33316
- South Florida CDC Ft Lauderdale NICHD CRS (5055)
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Jacksonville, Florida, Förenta staterna, 32209
- University of Florida Jacksonville (5051)
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Miami, Florida, Förenta staterna, 33136
- University of Miami Pediatric/Perinatal HIV/AIDS (4201)
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Miami, Florida, Förenta staterna, 33136
- Jackson Memorial Hosp
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St Petersburg, Florida, Förenta staterna, 33701
- University of South Florida at Tampa (5018)
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Georgia
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Augusta, Georgia, Förenta staterna, 30912
- Med College of Georgia
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Columbus, Georgia, Förenta staterna, 31901
- The Medical Center
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Illinois
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Chicago, Illinois, Förenta staterna, 60612
- Cook County Hospital
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Chicago, Illinois, Förenta staterna, 60608
- Mt Sinai Hosp Med Ctr / Dept of Pediatrics
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Chicago, Illinois, Förenta staterna, 60612
- Rush University Cook County Hospital NICHD CRS (5083)
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Chicago, Illinois, Förenta staterna, 60608-1797
- Womens & Childrens HIV Program
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Chicago, Illinois, Förenta staterna, 60612-7234
- Univ of Illinois
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Chicago, Illinois, Förenta staterna, 60614
- Chicago Childrens Memorial Hosp (Pediatric)
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Chicago, Illinois, Förenta staterna, 60637-1470
- Univ of Chicago Children's Hosp (4001)
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Louisiana
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New Orleans, Louisiana, Förenta staterna, 70112-2699
- Tulane University New Orleans (5095)
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New Orleans, Louisiana, Förenta staterna, 70112-2699
- Tulane-Lakeside Hospital
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New Orleans, Louisiana, Förenta staterna, 70112
- Tulane University Charity Hosp of New Orleans (7201)
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Maryland
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Baltimore, Maryland, Förenta staterna, 21287
- Johns Hopkins University NICHD CRS (5092)
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Baltimore, Maryland, Förenta staterna, 21201
- University of Maryland Baltimore NICHD CRS (5094)
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Massachusetts
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Boston, Massachusetts, Förenta staterna, 02115
- Children's Hospital of Boston NICHD CRS (5009)
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Boston, Massachusetts, Förenta staterna, 02118
- Boston Med Ctr (Pediatric) (5011)
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Boston, Massachusetts, Förenta staterna, 02478
- Brigham and Women's Hosp
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Springfield, Massachusetts, Förenta staterna, 01199
- Baystate Med Ctr of Springfield
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Worcester, Massachusetts, Förenta staterna, 01605
- WNE Maternal Pediatric Adolescent AIDS CRS (7301)
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Worcester, Massachusetts, Förenta staterna, 01655
- Univ of Massachusetts Med School
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Michigan
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Detroit, Michigan, Förenta staterna, 48201-1427
- Hutzel Hospital (5089)
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Detroit, Michigan, Förenta staterna, 48201
- Wayne State University Detroit Children's Hosp of Michigan (5041)
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Missouri
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St. Louis, Missouri, Förenta staterna, 63108-2138
- St. Louis Children's Hosp
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New Jersey
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Newark, New Jersey, Förenta staterna, 07103
- Univ of Med & Dentistry of New Jersey/Univ Hosp
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Newark, New Jersey, Förenta staterna, 07103-2714
- Univ of Medicine & Dentistry of New Jersey / Univ Hosp (P2802)
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Newark, New Jersey, Förenta staterna, 07103
- New Jersey Medical School (2802)
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New York
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Bronx, New York, Förenta staterna, 19461
- Montefiore Medical / AECOM
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Bronx, New York, Förenta staterna, 10451
- Lincoln Medical & Mental Health Center
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Bronx, New York, Förenta staterna, 10461
- Jacobi Med. Ctr. Bronx NICHD CRS (5013)
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Bronx, New York, Förenta staterna, 10457
- Bronx-Lebanon Hospital IMPAACT (6901)
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Brooklyn, New York, Förenta staterna, 11203-2098
- Children's Hospital at Downstate
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New York, New York, Förenta staterna, 10016
- New York University NY (5012)
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New York, New York, Förenta staterna, 10032
- Columbia IMPAACT CRS (4101)
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New York, New York, Förenta staterna, 10016
- NYU/Bellevue Hospital
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New York, New York, Förenta staterna, 10029
- Metropolitan Hosp Ctr (5003)
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Rochester, New York, Förenta staterna, 14642
- Univ of Rochester Med Ctr
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Stony Brook, New York, Förenta staterna, 11776
- State Univ of New York at Stony Brook (5040)
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Syracuse, New York, Förenta staterna, 13210
- SUNY Upstate Medical Univ
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North Carolina
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Durham, North Carolina, Förenta staterna, 27705
- Duke Univ (Pediatric) (DUMC) (4701)
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Oregon
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Portland, Oregon, Förenta staterna, 97239
- Oregon Health and Science University
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Pennsylvania
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Philadelphia, Pennsylvania, Förenta staterna, 19104
- Hospital of the University of Pennsylvania
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Philadelphia, Pennsylvania, Förenta staterna, 19102-1192
- Hahnemann University Hospital (6706)
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Philadelphia, Pennsylvania, Förenta staterna, 19134
- The Children's Hospital of Philadelphia (6701)
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Tennessee
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Memphis, Tennessee, Förenta staterna, 38105
- St. Jude Childrens Research Hosp, Memphis (6501)
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Memphis, Tennessee, Förenta staterna, 38105-2794
- The Regional Med Ctr, Memphis (6502)
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Nashville, Tennessee, Förenta staterna, 37232
- Vanderbilt Univ Med Ctr
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Texas
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Houston, Texas, Förenta staterna, 77030
- Texas Children's Hosp / Baylor Univ (3801)
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Washington
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Seattle, Washington, Förenta staterna, 98105
- Harborview Medical Center NICHD CRS (5027)
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Seattle, Washington, Förenta staterna, 98105
- University of Washington NICHD CRS (5029)
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Seattle, Washington, Förenta staterna, 98105-0371
- Univ of Washington Children's Hospital Seattle (5017)
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San Juan, Puerto Rico, 00936-5067
- University of Puerto Rico Pediatric HIV/AIDS (6601)
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San Juan, Puerto Rico, 00936-7344
- San Juan City Hosp. PR NICHD CRS (5031)
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
14 år och äldre (Barn, Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Kvinna
Testmetod
Sannolikhetsprov
Studera befolkning
Primary care clinics
Beskrivning
Inclusion Criteria:
- HIV infected
- At least 14 weeks pregnant OR have delivered a liveborn or stillborn infant and are within 14 days of the delivery
- Currently receiving care at an IMPAACT or other participating site
- Have a parent or guardian willing to provide signed informed consent, if applicable
- Mentally capable of giving informed consent to have the infant and self followed at an IMPAACT site
Exclusion Criteria:
- Intend to end the pregnancy
- Unable to come for a study visit within 14 days after delivery (if known to be HIV infected prior to delivery) OR within 28 days after delivery (if found to be HIV infected at the time of labor and delivery or within 14 days after delivery)
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
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1
Pregnant, HIV-infected women
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Adherence will be assessed using questionnaires at all study visits.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
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Maternal and infant response to prescribed interventions
Tidsram: Throughout study
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Throughout study
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Immune and viral parameters of participants taking prescribed interventions
Tidsram: Throughout study
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Throughout study
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Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
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Occurrences of genotypic and phenotypic resistance in HIV-infected mothers
Tidsram: Throughout study
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Throughout study
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Clinical, immunological, and virological responses in HIV-infected women
Tidsram: Throughout study
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Throughout study
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Mother-to-child transmission rates of resistance mutations
Tidsram: Throughout study
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Throughout study
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Adherence to ART among HIV-infected pregnant women during pregnancy and postpartum
Tidsram: Throughout study
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Throughout study
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Samarbetspartners
Utredare
- Studiestol: Ruth Tuomala, MD, Director of Obstetrics and Gynecology, Brigham and Women's Hospital
- Studiestol: Gwen Scott, MD, Pediatric Infectious Diseases, University of Miami School of Medicine
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- Ciambrone D, Loewenthal HG, Bazerman LB, Zorilla C, Urbina B, Mitty JA. Adherence among women with HIV infection in Puerto Rico: the potential use of modified directly observed therapy (MDOT) among pregnant and postpartum women. Women Health. 2006;44(4):61-77. doi: 10.1300/j013v44n04_04.
- Kingston MA, Letham CJ, McQuillan O. Adherence to antiretroviral therapy in pregnancy. Int J STD AIDS. 2007 Nov;18(11):787-9. doi: 10.1258/095646207782212216.
- Bardeguez AD, Lindsey JC, Shannon M, Tuomala RE, Cohn SE, Smith E, Stek A, Buschur S, Cotter A, Bettica L, Read JS; PACTG 1025 Protocol Team. Adherence to antiretrovirals among US women during and after pregnancy. J Acquir Immune Defic Syndr. 2008 Aug 1;48(4):408-17. doi: 10.1097/QAI.0b013e31817bbe80.
- Momplaisir F, Hussein M, Kacanek D, Brady K, Agwu A, Scott G, Tuomala R, Bennett D. Perinatal Depressive Symptoms, Human Immunodeficiency Virus (HIV) Suppression, and the Underlying Role of Antiretroviral Therapy Adherence: A Longitudinal Mediation Analysis in the IMPAACT P1025 Cohort. Clin Infect Dis. 2021 Oct 20;73(8):1379-1387. doi: 10.1093/cid/ciab416.
- Jao J, Kacanek D, Williams PL, Geffner ME, Livingston EG, Sperling RS, Patel K, Bardeguez AD, Burchett SK, Chakhtoura N, Scott GB, Van Dyke RB, Abrams EJ; Pediatric HIV/AIDS Cohort Study and the International Maternal Pediatric Adolescent AIDS Clinical Trials P1025 Protocol; Pediatric HIV/AIDS Cohort Study and the International Maternal Pediatric Adolescent AIDS Clinical Trials P1025 Protocol. Birth Weight and Preterm Delivery Outcomes of Perinatally vs Nonperinatally Human Immunodeficiency Virus-Infected Pregnant Women in the United States: Results From the PHACS SMARTT Study and IMPAACT P1025 Protocol. Clin Infect Dis. 2017 Sep 15;65(6):982-989. doi: 10.1093/cid/cix488.
- Scott GB, Brogly SB, Muenz D, Stek AM, Read JS; International Maternal Pediatric Adolescent AIDS Clinical Trials Group (IMPAACT) P1025 Study Team. Missed Opportunities for Prevention of Mother-to-Child Transmission of Human Immunodeficiency Virus. Obstet Gynecol. 2017 Apr;129(4):621-628. doi: 10.1097/AOG.0000000000001929.
- Livingston EG, Huo Y, Patel K, Tuomala RE, Scott GB, Stek A; P1025 Team of the International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) Group. Complications and Route of Delivery in a Large Cohort Study of HIV-1-Infected Women-IMPAACT P1025. J Acquir Immune Defic Syndr. 2016 Sep 1;73(1):74-82. doi: 10.1097/QAI.0000000000001021.
- Katz IT, Leister E, Kacanek D, Hughes MD, Bardeguez A, Livingston E, Stek A, Shapiro DE, Tuomala R. Factors associated with lack of viral suppression at delivery among highly active antiretroviral therapy-naive women with HIV: a cohort study. Ann Intern Med. 2015 Jan 20;162(2):90-9. doi: 10.7326/M13-2005.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 oktober 2002
Primärt slutförande (Faktisk)
1 juni 2013
Avslutad studie (Faktisk)
1 juni 2013
Studieregistreringsdatum
Först inskickad
13 december 2001
Först inskickad som uppfyllde QC-kriterierna
13 december 2001
Första postat (Uppskatta)
14 december 2001
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
10 oktober 2014
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
8 oktober 2014
Senast verifierad
1 oktober 2014
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- PACTG P1025
- U01AI068632 (U.S.S. NIH-anslag/kontrakt)
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .