Prenatal and Postnatal Studies of Interventions for Prevention of Mother-To-Child Transmission
8 oktober 2014 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Interventie / Behandeling
Gedetailleerde beschrijving
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
Observationeel
Inschrijving (Werkelijk)
3090
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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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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Alabama
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Birmingham, Alabama, Verenigde Staten, 35233
- Univ. of Alabama Birmingham NICHD CRS (5096)
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Mobile, Alabama, Verenigde Staten, 36688
- University of South Alabama
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Arizona
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Phoenix, Arizona, Verenigde Staten, 85006
- Phoenix Childrens Hospital
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California
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Long Beach, California, Verenigde Staten, 90801
- Long Beach Memorial (Pediatric)
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Long Beach, California, Verenigde Staten, 90806
- Miller Children's Hospital Long Beach (5093)
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Los Angeles, California, Verenigde Staten, 900951752
- UCLA Med Ctr / Pediatric
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Los Angeles, California, Verenigde Staten, 90033
- Usc La Nichd Crs (5048)
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Los Angeles, California, Verenigde Staten, 90095
- UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CR (3601)
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Los Angeles, California, Verenigde Staten, 90033
- Los Angeles County Medical Center/USC
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San Diego, California, Verenigde Staten, 92103
- Univ of California, San Diego (4601)
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San Francisco, California, Verenigde Staten, 94117
- Univ. of California San Francisco NICHD CRS (5091)
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Torrance, California, Verenigde Staten, 90509
- Harbor-UCLA Med Ctr (5045)
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Colorado
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Denver, Colorado, Verenigde Staten, 80218-1088
- University of Colorado Denver NICHD CRS (5052)
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Connecticut
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Farmington, Connecticut, Verenigde Staten, 06030-3805
- Connecticut Childrens Medical Center (Pediatric)
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Farmington, Connecticut, Verenigde Staten, 06030-3805
- University of Connecticut, Farmington
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New Haven, Connecticut, Verenigde Staten, 06504
- Yale Univ School of Med
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District of Columbia
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Washington, District of Columbia, Verenigde Staten, 20010-2970
- Children's National Medical Center Washington DC NICHD CRS (5015)
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Washington, District of Columbia, Verenigde Staten, 200102931
- Washington Hospital Center NICHD CRS (5023)
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Washington, District of Columbia, Verenigde Staten, 20060
- Howard Univ Hosp (5044)
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Florida
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Fort Lauderdale, Florida, Verenigde Staten, 33311
- North Broward Hosp District
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Ft Lauderdal, Florida, Verenigde Staten, 33316
- South Florida CDC Ft Lauderdale NICHD CRS (5055)
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Jacksonville, Florida, Verenigde Staten, 32209
- University of Florida Jacksonville (5051)
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Miami, Florida, Verenigde Staten, 33136
- University of Miami Pediatric/Perinatal HIV/AIDS (4201)
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Miami, Florida, Verenigde Staten, 33136
- Jackson Memorial Hosp
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St Petersburg, Florida, Verenigde Staten, 33701
- University of South Florida at Tampa (5018)
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Georgia
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Augusta, Georgia, Verenigde Staten, 30912
- Med College of Georgia
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Columbus, Georgia, Verenigde Staten, 31901
- The Medical Center
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Illinois
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Chicago, Illinois, Verenigde Staten, 60612
- Cook County Hospital
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Chicago, Illinois, Verenigde Staten, 60608
- Mt Sinai Hosp Med Ctr / Dept of Pediatrics
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Chicago, Illinois, Verenigde Staten, 60612
- Rush University Cook County Hospital NICHD CRS (5083)
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Chicago, Illinois, Verenigde Staten, 60608-1797
- Womens & Childrens HIV Program
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Chicago, Illinois, Verenigde Staten, 60612-7234
- Univ of Illinois
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Chicago, Illinois, Verenigde Staten, 60614
- Chicago Childrens Memorial Hosp (Pediatric)
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Chicago, Illinois, Verenigde Staten, 60637-1470
- Univ of Chicago Children's Hosp (4001)
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Louisiana
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New Orleans, Louisiana, Verenigde Staten, 70112-2699
- Tulane University New Orleans (5095)
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New Orleans, Louisiana, Verenigde Staten, 70112-2699
- Tulane-Lakeside Hospital
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New Orleans, Louisiana, Verenigde Staten, 70112
- Tulane University Charity Hosp of New Orleans (7201)
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Maryland
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Baltimore, Maryland, Verenigde Staten, 21287
- Johns Hopkins University NICHD CRS (5092)
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Baltimore, Maryland, Verenigde Staten, 21201
- University of Maryland Baltimore NICHD CRS (5094)
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Massachusetts
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Boston, Massachusetts, Verenigde Staten, 02115
- Children's Hospital of Boston NICHD CRS (5009)
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Boston, Massachusetts, Verenigde Staten, 02118
- Boston Med Ctr (Pediatric) (5011)
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Boston, Massachusetts, Verenigde Staten, 02478
- Brigham and Women's Hosp
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Springfield, Massachusetts, Verenigde Staten, 01199
- Baystate Med Ctr of Springfield
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Worcester, Massachusetts, Verenigde Staten, 01605
- WNE Maternal Pediatric Adolescent AIDS CRS (7301)
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Worcester, Massachusetts, Verenigde Staten, 01655
- Univ of Massachusetts Med School
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Michigan
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Detroit, Michigan, Verenigde Staten, 48201-1427
- Hutzel Hospital (5089)
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Detroit, Michigan, Verenigde Staten, 48201
- Wayne State University Detroit Children's Hosp of Michigan (5041)
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Missouri
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St. Louis, Missouri, Verenigde Staten, 63108-2138
- St. Louis Children's Hosp
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New Jersey
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Newark, New Jersey, Verenigde Staten, 07103
- Univ of Med & Dentistry of New Jersey/Univ Hosp
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Newark, New Jersey, Verenigde Staten, 07103-2714
- Univ of Medicine & Dentistry of New Jersey / Univ Hosp (P2802)
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Newark, New Jersey, Verenigde Staten, 07103
- New Jersey Medical School (2802)
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New York
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Bronx, New York, Verenigde Staten, 19461
- Montefiore Medical / AECOM
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Bronx, New York, Verenigde Staten, 10451
- Lincoln Medical & Mental Health Center
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Bronx, New York, Verenigde Staten, 10461
- Jacobi Med. Ctr. Bronx NICHD CRS (5013)
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Bronx, New York, Verenigde Staten, 10457
- Bronx-Lebanon Hospital IMPAACT (6901)
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Brooklyn, New York, Verenigde Staten, 11203-2098
- Children's Hospital at Downstate
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New York, New York, Verenigde Staten, 10016
- New York University NY (5012)
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New York, New York, Verenigde Staten, 10032
- Columbia IMPAACT CRS (4101)
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New York, New York, Verenigde Staten, 10016
- NYU/Bellevue Hospital
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New York, New York, Verenigde Staten, 10029
- Metropolitan Hosp Ctr (5003)
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Rochester, New York, Verenigde Staten, 14642
- Univ of Rochester Med Ctr
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Stony Brook, New York, Verenigde Staten, 11776
- State Univ of New York at Stony Brook (5040)
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Syracuse, New York, Verenigde Staten, 13210
- SUNY Upstate Medical Univ
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North Carolina
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Durham, North Carolina, Verenigde Staten, 27705
- Duke Univ (Pediatric) (DUMC) (4701)
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Oregon
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Portland, Oregon, Verenigde Staten, 97239
- Oregon Health and Science University
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Pennsylvania
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Philadelphia, Pennsylvania, Verenigde Staten, 19104
- Hospital of the University of Pennsylvania
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Philadelphia, Pennsylvania, Verenigde Staten, 19102-1192
- Hahnemann University Hospital (6706)
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Philadelphia, Pennsylvania, Verenigde Staten, 19134
- The Children's Hospital of Philadelphia (6701)
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Tennessee
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Memphis, Tennessee, Verenigde Staten, 38105
- St. Jude Childrens Research Hosp, Memphis (6501)
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Memphis, Tennessee, Verenigde Staten, 38105-2794
- The Regional Med Ctr, Memphis (6502)
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Nashville, Tennessee, Verenigde Staten, 37232
- Vanderbilt Univ Med Ctr
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Texas
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Houston, Texas, Verenigde Staten, 77030
- Texas Children's Hosp / Baylor Univ (3801)
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Washington
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Seattle, Washington, Verenigde Staten, 98105
- Harborview Medical Center NICHD CRS (5027)
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Seattle, Washington, Verenigde Staten, 98105
- University of Washington NICHD CRS (5029)
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Seattle, Washington, Verenigde Staten, 98105-0371
- Univ of Washington Children's Hospital Seattle (5017)
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
14 jaar en ouder (Kind, Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Vrouw
Bemonsteringsmethode
Kanssteekproef
Studie Bevolking
Primary care clinics
Beschrijving
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)
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
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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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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Maternal and infant response to prescribed interventions
Tijdsspanne: Throughout study
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Throughout study
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Immune and viral parameters of participants taking prescribed interventions
Tijdsspanne: Throughout study
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Throughout study
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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Occurrences of genotypic and phenotypic resistance in HIV-infected mothers
Tijdsspanne: Throughout study
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Throughout study
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Clinical, immunological, and virological responses in HIV-infected women
Tijdsspanne: Throughout study
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Throughout study
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Mother-to-child transmission rates of resistance mutations
Tijdsspanne: Throughout study
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Throughout study
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Adherence to ART among HIV-infected pregnant women during pregnancy and postpartum
Tijdsspanne: Throughout study
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Throughout study
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Medewerkers
Onderzoekers
- Studie stoel: Ruth Tuomala, MD, Director of Obstetrics and Gynecology, Brigham and Women's Hospital
- Studie stoel: Gwen Scott, MD, Pediatric Infectious Diseases, University of Miami School of Medicine
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- 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.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 oktober 2002
Primaire voltooiing (Werkelijk)
1 juni 2013
Studie voltooiing (Werkelijk)
1 juni 2013
Studieregistratiedata
Eerst ingediend
13 december 2001
Eerst ingediend dat voldeed aan de QC-criteria
13 december 2001
Eerst geplaatst (Schatting)
14 december 2001
Updates van studierecords
Laatste update geplaatst (Schatting)
10 oktober 2014
Laatste update ingediend die voldeed aan QC-criteria
8 oktober 2014
Laatst geverifieerd
1 oktober 2014
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- PACTG P1025
- U01AI068632 (Subsidie/contract van de Amerikaanse NIH)
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .