NCT00028145|CompletedDMC
Prenatal and Postnatal Studies of Interventions for Prevention of Mother-To-Child Transmission
Perinatal Core Protocol
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Perinatal Core Protocol
Sponsor study identifier
Secondary identifiers
NIH
observational
3,090
2 countries
77
Study Start
October 2002
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2013
Actual (reported)Study Completion
June 2013
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2013
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 13, 2001
Actual (reported)December 14, 2001
Actual (reported)October 2002
Date type not reportedThis date has not been verified as actual or estimated.
June 2013
Actual (reported)June 2013
Actual (reported)Maternal and infant response to prescribed interventions
Throughout study
Immune and viral parameters of participants taking prescribed interventions
Throughout study
Occurrences of genotypic and phenotypic resistance in HIV-infected mothers
Throughout study
Clinical, immunological, and virological responses in HIV-infected women
Throughout study
Mother-to-child transmission rates of resistance mutations
Throughout study
Adherence to ART among HIV-infected pregnant women during pregnancy and postpartum
Throughout study
Pregnant, HIV-infected women
Adherence will be assessed using questionnaires at all study visits.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Primary care clinics
Univ. of Alabama Birmingham NICHD CRS (5096)
Birmingham, Alabama, 35233, United States
University of South Alabama
Mobile, Alabama, 36688, United States
Phoenix Childrens Hospital
Phoenix, Arizona, 85006, United States
Long Beach Memorial (Pediatric)
Long Beach, California, 90801, United States
Miller Children's Hospital Long Beach (5093)
Long Beach, California, 90806, United States
Los Angeles County Medical Center/USC
Los Angeles, California, 90033, United States
Usc La Nichd Crs (5048)
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.
Blood and amniotic fluid
Ruth Tuomala, MD
Director of Obstetrics and Gynecology, Brigham and Women's Hospital
Gwen Scott, MD
Pediatric Infectious Diseases, University of Miami School of Medicine
3,090 participants (actual enrollment reported by the registry).
First Submitted
December 13, 2001
First Posted
December 14, 2001
Study Start
October 2002
Date type not reportedThis date has not been verified as actual or estimated.
Safety of Tenofovir Disoproxil Fumarate (TDF) and Emtricitabine/TDF in HIV Infected Pregnant Women and Their Infants
Contact the study team to confirm eligibility.
Los Angeles, California, 90033, United States
UCLA Med Ctr / Pediatric
Los Angeles, California, 900951752, United States
UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CR (3601)
Los Angeles, California, 90095, United States
Univ of California, San Diego (4601)
San Diego, California, 92103, United States
Univ. of California San Francisco NICHD CRS (5091)
San Francisco, California, 94117, United States
Harbor-UCLA Med Ctr (5045)
Torrance, California, 90509, United States
University of Colorado Denver NICHD CRS (5052)
Denver, Colorado, 80218-1088, United States
Connecticut Childrens Medical Center (Pediatric)
Farmington, Connecticut, 06030-3805, United States
University of Connecticut, Farmington
Farmington, Connecticut, 06030-3805, United States
Yale Univ School of Med
New Haven, Connecticut, 06504, United States
Children's National Medical Center Washington DC NICHD CRS (5015)
Washington D.C., District of Columbia, 20010-2970, United States
Washington Hospital Center NICHD CRS (5023)
Washington D.C., District of Columbia, 200102931, United States
Howard Univ Hosp (5044)
Washington D.C., District of Columbia, 20060, United States
North Broward Hosp District
Fort Lauderdale, Florida, 33311, United States
South Florida CDC Ft Lauderdale NICHD CRS (5055)
Fort Lauderdal, Florida, 33316, United States
University of Florida Jacksonville (5051)
Jacksonville, Florida, 32209, United States
Jackson Memorial Hosp
Miami, Florida, 33136, United States
University of Miami Pediatric/Perinatal HIV/AIDS (4201)
Miami, Florida, 33136, United States
University of South Florida at Tampa (5018)
St. Petersburg, Florida, 33701, United States
Med College of Georgia
Augusta, Georgia, 30912, United States
The Medical Center
Columbus, Georgia, 31901, United States
Womens & Childrens HIV Program
Chicago, Illinois, 60608-1797, United States
Mt Sinai Hosp Med Ctr / Dept of Pediatrics
Chicago, Illinois, 60608, United States
Univ of Illinois
Chicago, Illinois, 60612-7234, United States
Cook County Hospital
Chicago, Illinois, 60612, United States
Rush University Cook County Hospital NICHD CRS (5083)
Chicago, Illinois, 60612, United States
Chicago Childrens Memorial Hosp (Pediatric)
Chicago, Illinois, 60614, United States
Univ of Chicago Children's Hosp (4001)
Chicago, Illinois, 60637-1470, United States
Tulane University New Orleans (5095)
New Orleans, Louisiana, 70112-2699, United States
Tulane-Lakeside Hospital
New Orleans, Louisiana, 70112-2699, United States
Tulane University Charity Hosp of New Orleans (7201)
New Orleans, Louisiana, 70112, United States
University of Maryland Baltimore NICHD CRS (5094)
Baltimore, Maryland, 21201, United States
Johns Hopkins University NICHD CRS (5092)
Baltimore, Maryland, 21287, United States
Children's Hospital of Boston NICHD CRS (5009)
Boston, Massachusetts, 02115, United States
Boston Med Ctr (Pediatric) (5011)
Boston, Massachusetts, 02118, United States
Brigham and Women's Hosp
Boston, Massachusetts, 02478, United States
Baystate Med Ctr of Springfield
Springfield, Massachusetts, 01199, United States
WNE Maternal Pediatric Adolescent AIDS CRS (7301)
Worcester, Massachusetts, 01605, United States
Univ of Massachusetts Med School
Worcester, Massachusetts, 01655, United States
Hutzel Hospital (5089)
Detroit, Michigan, 48201-1427, United States
Wayne State University Detroit Children's Hosp of Michigan (5041)
Detroit, Michigan, 48201, United States
St. Louis Children's Hosp
St Louis, Missouri, 63108-2138, United States
Univ of Medicine & Dentistry of New Jersey / Univ Hosp (P2802)
Newark, New Jersey, 07103-2714, United States
New Jersey Medical School (2802)
Newark, New Jersey, 07103, United States
Univ of Med & Dentistry of New Jersey/Univ Hosp
Newark, New Jersey, 07103, United States
Children's Hospital at Downstate
Brooklyn, New York, 11203-2098, United States
New York University NY (5012)
New York, New York, 10016, United States
NYU/Bellevue Hospital
New York, New York, 10016, United States
Metropolitan Hosp Ctr (5003)
New York, New York, 10029, United States
Columbia IMPAACT CRS (4101)
New York, New York, 10032, United States
Univ of Rochester Med Ctr
Rochester, New York, 14642, United States
State Univ of New York at Stony Brook (5040)
Stony Brook, New York, 11776, United States
SUNY Upstate Medical Univ
Syracuse, New York, 13210, United States
Lincoln Medical & Mental Health Center
The Bronx, New York, 10451, United States
Bronx-Lebanon Hospital IMPAACT (6901)
The Bronx, New York, 10457, United States
Jacobi Med. Ctr. Bronx NICHD CRS (5013)
The Bronx, New York, 10461, United States
Montefiore Medical / AECOM
The Bronx, New York, 19461, United States
Duke Univ (Pediatric) (DUMC) (4701)
Durham, North Carolina, 27705, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
Hahnemann University Hospital (6706)
Philadelphia, Pennsylvania, 19102-1192, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
The Children's Hospital of Philadelphia (6701)
Philadelphia, Pennsylvania, 19134, United States
The Regional Med Ctr, Memphis (6502)
Memphis, Tennessee, 38105-2794, United States
St. Jude Childrens Research Hosp, Memphis (6501)
Memphis, Tennessee, 38105, United States
Vanderbilt Univ Med Ctr
Nashville, Tennessee, 37232, United States
Texas Children's Hosp / Baylor Univ (3801)
Houston, Texas, 77030, United States
Univ of Washington Children's Hospital Seattle (5017)
Seattle, Washington, 98105-0371, United States
Harborview Medical Center NICHD CRS (5027)
Seattle, Washington, 98105, United States
University of Washington NICHD CRS (5029)
Seattle, Washington, 98105, United States
University of Puerto Rico Pediatric HIV/AIDS (6601)
San Juan, 00936-5067, Puerto Rico
San Juan City Hosp. PR NICHD CRS (5031)
San Juan, 00936-7344, Puerto Rico
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.
Primary Completion
June 2013
Actual (reported)Study Completion
June 2013
Actual (reported)Last Updated
October 10, 2014
Record last verified: 2014-10
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Source: ClinicalTrials.gov.
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