Prenatal and Postnatal Studies of Interventions for Prevention of Mother-To-Child Transmission
- Conditions
- Pregnancy Complications, InfectiousHIV Infections
- Interventions
- Behavioral: Adherence assessment
- Registration Number
- NCT00028145
- Lead Sponsor
- International Maternal Pediatric Adolescent AIDS Clinical Trials Group
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 3090
- 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
- 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)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description 1 Adherence assessment Pregnant, HIV-infected women
- Primary Outcome Measures
Name Time Method Maternal and infant response to prescribed interventions Throughout study Immune and viral parameters of participants taking prescribed interventions Throughout study
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (77)
UCLA Med Ctr / Pediatric
🇺🇸Los Angeles, California, United States
University of Connecticut, Farmington
🇺🇸Farmington, Connecticut, United States
The Children's Hospital of Philadelphia (6701)
🇺🇸Philadelphia, Pennsylvania, United States
Univ of Illinois
🇺🇸Chicago, Illinois, United States
Chicago Childrens Memorial Hosp (Pediatric)
🇺🇸Chicago, Illinois, United States
Univ of Chicago Children's Hosp (4001)
🇺🇸Chicago, Illinois, United States
Brigham and Women's Hosp
🇺🇸Boston, Massachusetts, United States
Texas Children's Hosp / Baylor Univ (3801)
🇺🇸Houston, Texas, United States
Univ of Washington Children's Hospital Seattle (5017)
🇺🇸Seattle, Washington, United States
Harborview Medical Center NICHD CRS (5027)
🇺🇸Seattle, Washington, United States
University of Washington NICHD CRS (5029)
🇺🇸Seattle, Washington, United States
Univ of California, San Diego (4601)
🇺🇸San Diego, California, United States
Los Angeles County Medical Center/USC
🇺🇸Los Angeles, California, United States
Long Beach Memorial (Pediatric)
🇺🇸Long Beach, California, United States
Miller Children's Hospital Long Beach (5093)
🇺🇸Long Beach, California, United States
University of South Alabama
🇺🇸Mobile, Alabama, United States
Usc La Nichd Crs (5048)
🇺🇸Los Angeles, California, United States
UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CR (3601)
🇺🇸Los Angeles, California, United States
Harbor-UCLA Med Ctr (5045)
🇺🇸Torrance, California, United States
Connecticut Childrens Medical Center (Pediatric)
🇺🇸Farmington, Connecticut, United States
Yale Univ School of Med
🇺🇸New Haven, Connecticut, United States
Children's National Medical Center Washington DC NICHD CRS (5015)
🇺🇸Washington, District of Columbia, United States
Washington Hospital Center NICHD CRS (5023)
🇺🇸Washington, District of Columbia, United States
North Broward Hosp District
🇺🇸Fort Lauderdale, Florida, United States
South Florida CDC Ft Lauderdale NICHD CRS (5055)
🇺🇸Ft Lauderdal, Florida, United States
Jackson Memorial Hosp
🇺🇸Miami, Florida, United States
University of Florida Jacksonville (5051)
🇺🇸Jacksonville, Florida, United States
University of Miami Pediatric/Perinatal HIV/AIDS (4201)
🇺🇸Miami, Florida, United States
University of South Florida at Tampa (5018)
🇺🇸St Petersburg, Florida, United States
Med College of Georgia
🇺🇸Augusta, Georgia, United States
Womens & Childrens HIV Program
🇺🇸Chicago, Illinois, United States
Mt Sinai Hosp Med Ctr / Dept of Pediatrics
🇺🇸Chicago, Illinois, United States
The Medical Center
🇺🇸Columbus, Georgia, United States
Cook County Hospital
🇺🇸Chicago, Illinois, United States
Rush University Cook County Hospital NICHD CRS (5083)
🇺🇸Chicago, Illinois, United States
Tulane University New Orleans (5095)
🇺🇸New Orleans, Louisiana, United States
University of Maryland Baltimore NICHD CRS (5094)
🇺🇸Baltimore, Maryland, United States
Tulane-Lakeside Hospital
🇺🇸New Orleans, Louisiana, United States
Tulane University Charity Hosp of New Orleans (7201)
🇺🇸New Orleans, Louisiana, United States
Johns Hopkins University NICHD CRS (5092)
🇺🇸Baltimore, Maryland, United States
Children's Hospital of Boston NICHD CRS (5009)
🇺🇸Boston, Massachusetts, United States
Boston Med Ctr (Pediatric) (5011)
🇺🇸Boston, Massachusetts, United States
Baystate Med Ctr of Springfield
🇺🇸Springfield, Massachusetts, United States
WNE Maternal Pediatric Adolescent AIDS CRS (7301)
🇺🇸Worcester, Massachusetts, United States
Univ of Massachusetts Med School
🇺🇸Worcester, Massachusetts, United States
St. Louis Children's Hosp
🇺🇸St. Louis, Missouri, United States
Univ of Medicine & Dentistry of New Jersey / Univ Hosp (P2802)
🇺🇸Newark, New Jersey, United States
New Jersey Medical School (2802)
🇺🇸Newark, New Jersey, United States
Lincoln Medical & Mental Health Center
🇺🇸Bronx, New York, United States
Univ of Med & Dentistry of New Jersey/Univ Hosp
🇺🇸Newark, New Jersey, United States
Bronx-Lebanon Hospital IMPAACT (6901)
🇺🇸Bronx, New York, United States
Jacobi Med. Ctr. Bronx NICHD CRS (5013)
🇺🇸Bronx, New York, United States
Montefiore Medical / AECOM
🇺🇸Bronx, New York, United States
New York University NY (5012)
🇺🇸New York, New York, United States
NYU/Bellevue Hospital
🇺🇸New York, New York, United States
Metropolitan Hosp Ctr (5003)
🇺🇸New York, New York, United States
Columbia IMPAACT CRS (4101)
🇺🇸New York, New York, United States
Univ of Rochester Med Ctr
🇺🇸Rochester, New York, United States
Children's Hospital at Downstate
🇺🇸Brooklyn, New York, United States
State Univ of New York at Stony Brook (5040)
🇺🇸Stony Brook, New York, United States
SUNY Upstate Medical Univ
🇺🇸Syracuse, New York, United States
Hahnemann University Hospital (6706)
🇺🇸Philadelphia, Pennsylvania, United States
Hospital of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
The Regional Med Ctr, Memphis (6502)
🇺🇸Memphis, Tennessee, United States
St. Jude Childrens Research Hosp, Memphis (6501)
🇺🇸Memphis, Tennessee, United States
University of Puerto Rico Pediatric HIV/AIDS (6601)
🇵🇷San Juan, Puerto Rico
San Juan City Hosp. PR NICHD CRS (5031)
🇵🇷San Juan, Puerto Rico
Duke Univ (Pediatric) (DUMC) (4701)
🇺🇸Durham, North Carolina, United States
Univ. of California San Francisco NICHD CRS (5091)
🇺🇸San Francisco, California, United States
Vanderbilt Univ Med Ctr
🇺🇸Nashville, Tennessee, United States
Univ. of Alabama Birmingham NICHD CRS (5096)
🇺🇸Birmingham, Alabama, United States
Phoenix Childrens Hospital
🇺🇸Phoenix, Arizona, United States
Hutzel Hospital (5089)
🇺🇸Detroit, Michigan, United States
University of Colorado Denver NICHD CRS (5052)
🇺🇸Denver, Colorado, United States
Wayne State University Detroit Children's Hosp of Michigan (5041)
🇺🇸Detroit, Michigan, United States
Oregon Health and Science University
🇺🇸Portland, Oregon, United States
Howard Univ Hosp (5044)
🇺🇸Washington, District of Columbia, United States