Prenatal and Postnatal Studies of Interventions for Prevention of Mother-To-Child Transmission
8 octobre 2014 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Observationnel
Inscription (Réel)
3090
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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San Juan, Porto Rico, 00936-5067
- University of Puerto Rico Pediatric HIV/AIDS (6601)
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San Juan, Porto Rico, 00936-7344
- San Juan City Hosp. PR NICHD CRS (5031)
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Alabama
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Birmingham, Alabama, États-Unis, 35233
- Univ. of Alabama Birmingham NICHD CRS (5096)
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Mobile, Alabama, États-Unis, 36688
- University of South Alabama
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Arizona
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Phoenix, Arizona, États-Unis, 85006
- Phoenix Childrens Hospital
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California
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Long Beach, California, États-Unis, 90801
- Long Beach Memorial (Pediatric)
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Long Beach, California, États-Unis, 90806
- Miller Children's Hospital Long Beach (5093)
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Los Angeles, California, États-Unis, 900951752
- UCLA Med Ctr / Pediatric
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Los Angeles, California, États-Unis, 90033
- Usc La Nichd Crs (5048)
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Los Angeles, California, États-Unis, 90095
- UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CR (3601)
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Los Angeles, California, États-Unis, 90033
- Los Angeles County Medical Center/USC
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San Diego, California, États-Unis, 92103
- Univ of California, San Diego (4601)
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San Francisco, California, États-Unis, 94117
- Univ. of California San Francisco NICHD CRS (5091)
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Torrance, California, États-Unis, 90509
- Harbor-UCLA Med Ctr (5045)
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Colorado
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Denver, Colorado, États-Unis, 80218-1088
- University of Colorado Denver NICHD CRS (5052)
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Connecticut
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Farmington, Connecticut, États-Unis, 06030-3805
- Connecticut Childrens Medical Center (Pediatric)
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Farmington, Connecticut, États-Unis, 06030-3805
- University of Connecticut, Farmington
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New Haven, Connecticut, États-Unis, 06504
- Yale Univ School of Med
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District of Columbia
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Washington, District of Columbia, États-Unis, 20010-2970
- Children's National Medical Center Washington DC NICHD CRS (5015)
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Washington, District of Columbia, États-Unis, 200102931
- Washington Hospital Center NICHD CRS (5023)
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Washington, District of Columbia, États-Unis, 20060
- Howard Univ Hosp (5044)
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Florida
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Fort Lauderdale, Florida, États-Unis, 33311
- North Broward Hosp District
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Ft Lauderdal, Florida, États-Unis, 33316
- South Florida CDC Ft Lauderdale NICHD CRS (5055)
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Jacksonville, Florida, États-Unis, 32209
- University of Florida Jacksonville (5051)
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Miami, Florida, États-Unis, 33136
- University of Miami Pediatric/Perinatal HIV/AIDS (4201)
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Miami, Florida, États-Unis, 33136
- Jackson Memorial Hosp
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St Petersburg, Florida, États-Unis, 33701
- University of South Florida at Tampa (5018)
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Georgia
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Augusta, Georgia, États-Unis, 30912
- Med College of Georgia
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Columbus, Georgia, États-Unis, 31901
- The Medical Center
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Illinois
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Chicago, Illinois, États-Unis, 60612
- Cook County Hospital
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Chicago, Illinois, États-Unis, 60608
- Mt Sinai Hosp Med Ctr / Dept of Pediatrics
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Chicago, Illinois, États-Unis, 60612
- Rush University Cook County Hospital NICHD CRS (5083)
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Chicago, Illinois, États-Unis, 60608-1797
- Womens & Childrens HIV Program
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Chicago, Illinois, États-Unis, 60612-7234
- Univ of Illinois
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Chicago, Illinois, États-Unis, 60614
- Chicago Childrens Memorial Hosp (Pediatric)
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Chicago, Illinois, États-Unis, 60637-1470
- Univ of Chicago Children's Hosp (4001)
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Louisiana
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New Orleans, Louisiana, États-Unis, 70112-2699
- Tulane University New Orleans (5095)
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New Orleans, Louisiana, États-Unis, 70112-2699
- Tulane-Lakeside Hospital
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New Orleans, Louisiana, États-Unis, 70112
- Tulane University Charity Hosp of New Orleans (7201)
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Maryland
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Baltimore, Maryland, États-Unis, 21287
- Johns Hopkins University NICHD CRS (5092)
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Baltimore, Maryland, États-Unis, 21201
- University of Maryland Baltimore NICHD CRS (5094)
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Massachusetts
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Boston, Massachusetts, États-Unis, 02115
- Children's Hospital of Boston NICHD CRS (5009)
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Boston, Massachusetts, États-Unis, 02118
- Boston Med Ctr (Pediatric) (5011)
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Boston, Massachusetts, États-Unis, 02478
- Brigham and Women's Hosp
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Springfield, Massachusetts, États-Unis, 01199
- Baystate Med Ctr of Springfield
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Worcester, Massachusetts, États-Unis, 01605
- WNE Maternal Pediatric Adolescent AIDS CRS (7301)
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Worcester, Massachusetts, États-Unis, 01655
- Univ of Massachusetts Med School
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Michigan
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Detroit, Michigan, États-Unis, 48201-1427
- Hutzel Hospital (5089)
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Detroit, Michigan, États-Unis, 48201
- Wayne State University Detroit Children's Hosp of Michigan (5041)
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Missouri
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St. Louis, Missouri, États-Unis, 63108-2138
- St. Louis Children's Hosp
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New Jersey
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Newark, New Jersey, États-Unis, 07103
- Univ of Med & Dentistry of New Jersey/Univ Hosp
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Newark, New Jersey, États-Unis, 07103-2714
- Univ of Medicine & Dentistry of New Jersey / Univ Hosp (P2802)
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Newark, New Jersey, États-Unis, 07103
- New Jersey Medical School (2802)
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New York
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Bronx, New York, États-Unis, 19461
- Montefiore Medical / AECOM
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Bronx, New York, États-Unis, 10451
- Lincoln Medical & Mental Health Center
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Bronx, New York, États-Unis, 10461
- Jacobi Med. Ctr. Bronx NICHD CRS (5013)
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Bronx, New York, États-Unis, 10457
- Bronx-Lebanon Hospital IMPAACT (6901)
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Brooklyn, New York, États-Unis, 11203-2098
- Children's Hospital at Downstate
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New York, New York, États-Unis, 10016
- New York University NY (5012)
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New York, New York, États-Unis, 10032
- Columbia IMPAACT CRS (4101)
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New York, New York, États-Unis, 10016
- NYU/Bellevue Hospital
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New York, New York, États-Unis, 10029
- Metropolitan Hosp Ctr (5003)
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Rochester, New York, États-Unis, 14642
- Univ of Rochester Med Ctr
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Stony Brook, New York, États-Unis, 11776
- State Univ of New York at Stony Brook (5040)
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Syracuse, New York, États-Unis, 13210
- SUNY Upstate Medical Univ
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North Carolina
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Durham, North Carolina, États-Unis, 27705
- Duke Univ (Pediatric) (DUMC) (4701)
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Oregon
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Portland, Oregon, États-Unis, 97239
- Oregon Health and Science University
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Pennsylvania
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Philadelphia, Pennsylvania, États-Unis, 19104
- Hospital of the University of Pennsylvania
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Philadelphia, Pennsylvania, États-Unis, 19102-1192
- Hahnemann University Hospital (6706)
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Philadelphia, Pennsylvania, États-Unis, 19134
- The Children's Hospital of Philadelphia (6701)
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Tennessee
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Memphis, Tennessee, États-Unis, 38105
- St. Jude Childrens Research Hosp, Memphis (6501)
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Memphis, Tennessee, États-Unis, 38105-2794
- The Regional Med Ctr, Memphis (6502)
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Nashville, Tennessee, États-Unis, 37232
- Vanderbilt Univ Med Ctr
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Texas
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Houston, Texas, États-Unis, 77030
- Texas Children's Hosp / Baylor Univ (3801)
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Washington
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Seattle, Washington, États-Unis, 98105
- Harborview Medical Center NICHD CRS (5027)
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Seattle, Washington, États-Unis, 98105
- University of Washington NICHD CRS (5029)
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Seattle, Washington, États-Unis, 98105-0371
- Univ of Washington Children's Hospital Seattle (5017)
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
14 ans et plus (Enfant, Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Femelle
Méthode d'échantillonnage
Échantillon de probabilité
Population étudiée
Primary care clinics
La description
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)
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
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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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
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Maternal and infant response to prescribed interventions
Délai: Throughout study
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Throughout study
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Immune and viral parameters of participants taking prescribed interventions
Délai: Throughout study
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Throughout study
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
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Occurrences of genotypic and phenotypic resistance in HIV-infected mothers
Délai: Throughout study
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Throughout study
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Clinical, immunological, and virological responses in HIV-infected women
Délai: Throughout study
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Throughout study
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Mother-to-child transmission rates of resistance mutations
Délai: Throughout study
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Throughout study
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Adherence to ART among HIV-infected pregnant women during pregnancy and postpartum
Délai: Throughout study
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Throughout study
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Collaborateurs
Les enquêteurs
- Chaise d'étude: Ruth Tuomala, MD, Director of Obstetrics and Gynecology, Brigham and Women's Hospital
- Chaise d'étude: Gwen Scott, MD, Pediatric Infectious Diseases, University of Miami School of Medicine
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 octobre 2002
Achèvement primaire (Réel)
1 juin 2013
Achèvement de l'étude (Réel)
1 juin 2013
Dates d'inscription aux études
Première soumission
13 décembre 2001
Première soumission répondant aux critères de contrôle qualité
13 décembre 2001
Première publication (Estimation)
14 décembre 2001
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
10 octobre 2014
Dernière mise à jour soumise répondant aux critères de contrôle qualité
8 octobre 2014
Dernière vérification
1 octobre 2014
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- PACTG P1025
- U01AI068632 (Subvention/contrat des NIH des États-Unis)
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