Prenatal and Postnatal Studies of Interventions for Prevention of Mother-To-Child Transmission
8. oktober 2014 oppdatert 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.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Observasjonsmessig
Registrering (Faktiske)
3090
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Alabama
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Birmingham, Alabama, Forente stater, 35233
- Univ. of Alabama Birmingham NICHD CRS (5096)
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Mobile, Alabama, Forente stater, 36688
- University of South Alabama
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Arizona
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Phoenix, Arizona, Forente stater, 85006
- Phoenix Childrens Hospital
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California
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Long Beach, California, Forente stater, 90801
- Long Beach Memorial (Pediatric)
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Long Beach, California, Forente stater, 90806
- Miller Children's Hospital Long Beach (5093)
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Los Angeles, California, Forente stater, 900951752
- UCLA Med Ctr / Pediatric
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Los Angeles, California, Forente stater, 90033
- Usc La Nichd Crs (5048)
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Los Angeles, California, Forente stater, 90095
- UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CR (3601)
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Los Angeles, California, Forente stater, 90033
- Los Angeles County Medical Center/USC
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San Diego, California, Forente stater, 92103
- Univ of California, San Diego (4601)
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San Francisco, California, Forente stater, 94117
- Univ. of California San Francisco NICHD CRS (5091)
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Torrance, California, Forente stater, 90509
- Harbor-UCLA Med Ctr (5045)
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Colorado
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Denver, Colorado, Forente stater, 80218-1088
- University of Colorado Denver NICHD CRS (5052)
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Connecticut
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Farmington, Connecticut, Forente stater, 06030-3805
- Connecticut Childrens Medical Center (Pediatric)
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Farmington, Connecticut, Forente stater, 06030-3805
- University of Connecticut, Farmington
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New Haven, Connecticut, Forente stater, 06504
- Yale Univ School of Med
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District of Columbia
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Washington, District of Columbia, Forente stater, 20010-2970
- Children's National Medical Center Washington DC NICHD CRS (5015)
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Washington, District of Columbia, Forente stater, 200102931
- Washington Hospital Center NICHD CRS (5023)
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Washington, District of Columbia, Forente stater, 20060
- Howard Univ Hosp (5044)
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Florida
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Fort Lauderdale, Florida, Forente stater, 33311
- North Broward Hosp District
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Ft Lauderdal, Florida, Forente stater, 33316
- South Florida CDC Ft Lauderdale NICHD CRS (5055)
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Jacksonville, Florida, Forente stater, 32209
- University of Florida Jacksonville (5051)
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Miami, Florida, Forente stater, 33136
- University of Miami Pediatric/Perinatal HIV/AIDS (4201)
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Miami, Florida, Forente stater, 33136
- Jackson Memorial Hosp
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St Petersburg, Florida, Forente stater, 33701
- University of South Florida at Tampa (5018)
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Georgia
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Augusta, Georgia, Forente stater, 30912
- Med College of Georgia
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Columbus, Georgia, Forente stater, 31901
- The Medical Center
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Illinois
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Chicago, Illinois, Forente stater, 60612
- Cook County Hospital
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Chicago, Illinois, Forente stater, 60608
- Mt Sinai Hosp Med Ctr / Dept of Pediatrics
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Chicago, Illinois, Forente stater, 60612
- Rush University Cook County Hospital NICHD CRS (5083)
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Chicago, Illinois, Forente stater, 60608-1797
- Womens & Childrens HIV Program
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Chicago, Illinois, Forente stater, 60612-7234
- Univ of Illinois
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Chicago, Illinois, Forente stater, 60614
- Chicago Childrens Memorial Hosp (Pediatric)
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Chicago, Illinois, Forente stater, 60637-1470
- Univ of Chicago Children's Hosp (4001)
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Louisiana
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New Orleans, Louisiana, Forente stater, 70112-2699
- Tulane University New Orleans (5095)
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New Orleans, Louisiana, Forente stater, 70112-2699
- Tulane-Lakeside Hospital
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New Orleans, Louisiana, Forente stater, 70112
- Tulane University Charity Hosp of New Orleans (7201)
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Maryland
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Baltimore, Maryland, Forente stater, 21287
- Johns Hopkins University NICHD CRS (5092)
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Baltimore, Maryland, Forente stater, 21201
- University of Maryland Baltimore NICHD CRS (5094)
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Massachusetts
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Boston, Massachusetts, Forente stater, 02115
- Children's Hospital of Boston NICHD CRS (5009)
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Boston, Massachusetts, Forente stater, 02118
- Boston Med Ctr (Pediatric) (5011)
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Boston, Massachusetts, Forente stater, 02478
- Brigham and Women's Hosp
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Springfield, Massachusetts, Forente stater, 01199
- Baystate Med Ctr of Springfield
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Worcester, Massachusetts, Forente stater, 01605
- WNE Maternal Pediatric Adolescent AIDS CRS (7301)
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Worcester, Massachusetts, Forente stater, 01655
- Univ of Massachusetts Med School
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Michigan
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Detroit, Michigan, Forente stater, 48201-1427
- Hutzel Hospital (5089)
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Detroit, Michigan, Forente stater, 48201
- Wayne State University Detroit Children's Hosp of Michigan (5041)
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Missouri
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St. Louis, Missouri, Forente stater, 63108-2138
- St. Louis Children's Hosp
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New Jersey
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Newark, New Jersey, Forente stater, 07103
- Univ of Med & Dentistry of New Jersey/Univ Hosp
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Newark, New Jersey, Forente stater, 07103-2714
- Univ of Medicine & Dentistry of New Jersey / Univ Hosp (P2802)
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Newark, New Jersey, Forente stater, 07103
- New Jersey Medical School (2802)
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New York
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Bronx, New York, Forente stater, 19461
- Montefiore Medical / AECOM
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Bronx, New York, Forente stater, 10451
- Lincoln Medical & Mental Health Center
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Bronx, New York, Forente stater, 10461
- Jacobi Med. Ctr. Bronx NICHD CRS (5013)
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Bronx, New York, Forente stater, 10457
- Bronx-Lebanon Hospital IMPAACT (6901)
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Brooklyn, New York, Forente stater, 11203-2098
- Children's Hospital at Downstate
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New York, New York, Forente stater, 10016
- New York University NY (5012)
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New York, New York, Forente stater, 10032
- Columbia IMPAACT CRS (4101)
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New York, New York, Forente stater, 10016
- NYU/Bellevue Hospital
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New York, New York, Forente stater, 10029
- Metropolitan Hosp Ctr (5003)
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Rochester, New York, Forente stater, 14642
- Univ of Rochester Med Ctr
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Stony Brook, New York, Forente stater, 11776
- State Univ of New York at Stony Brook (5040)
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Syracuse, New York, Forente stater, 13210
- SUNY Upstate Medical Univ
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North Carolina
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Durham, North Carolina, Forente stater, 27705
- Duke Univ (Pediatric) (DUMC) (4701)
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Oregon
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Portland, Oregon, Forente stater, 97239
- Oregon Health and Science University
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Pennsylvania
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Philadelphia, Pennsylvania, Forente stater, 19104
- Hospital of the University of Pennsylvania
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Philadelphia, Pennsylvania, Forente stater, 19102-1192
- Hahnemann University Hospital (6706)
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Philadelphia, Pennsylvania, Forente stater, 19134
- The Children's Hospital of Philadelphia (6701)
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Tennessee
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Memphis, Tennessee, Forente stater, 38105
- St. Jude Childrens Research Hosp, Memphis (6501)
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Memphis, Tennessee, Forente stater, 38105-2794
- The Regional Med Ctr, Memphis (6502)
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Nashville, Tennessee, Forente stater, 37232
- Vanderbilt Univ Med Ctr
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Texas
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Houston, Texas, Forente stater, 77030
- Texas Children's Hosp / Baylor Univ (3801)
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Washington
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Seattle, Washington, Forente stater, 98105
- Harborview Medical Center NICHD CRS (5027)
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Seattle, Washington, Forente stater, 98105
- University of Washington NICHD CRS (5029)
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Seattle, Washington, Forente stater, 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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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
14 år og eldre (Barn, Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Hunn
Prøvetakingsmetode
Sannsynlighetsprøve
Studiepopulasjon
Primary care clinics
Beskrivelse
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Maternal and infant response to prescribed interventions
Tidsramme: Throughout study
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Throughout study
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Immune and viral parameters of participants taking prescribed interventions
Tidsramme: Throughout study
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Throughout study
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Occurrences of genotypic and phenotypic resistance in HIV-infected mothers
Tidsramme: Throughout study
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Throughout study
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Clinical, immunological, and virological responses in HIV-infected women
Tidsramme: Throughout study
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Throughout study
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Mother-to-child transmission rates of resistance mutations
Tidsramme: Throughout study
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Throughout study
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Adherence to ART among HIV-infected pregnant women during pregnancy and postpartum
Tidsramme: Throughout study
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Throughout study
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Etterforskere
- 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
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. oktober 2002
Primær fullføring (Faktiske)
1. juni 2013
Studiet fullført (Faktiske)
1. juni 2013
Datoer for studieregistrering
Først innsendt
13. desember 2001
Først innsendt som oppfylte QC-kriteriene
13. desember 2001
Først lagt ut (Anslag)
14. desember 2001
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
10. oktober 2014
Siste oppdatering sendt inn som oppfylte QC-kriteriene
8. oktober 2014
Sist bekreftet
1. oktober 2014
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- PACTG P1025
- U01AI068632 (U.S. NIH-stipend/kontrakt)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .