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Prenatal and Postnatal Studie...

Prenatal and Postnatal Studies of Interventions for Prevention of Mother-To-Child Transmission

Last Updated: 2014-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3090 participants

Study Classification

OBSERVATIONAL

Study Start Date

2002-10-31

Study Completion Date

2013-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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HIV Infections Pregnancy Complications, Infectious

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Pregnant, HIV-infected women

Adherence assessment

Intervention Type BEHAVIORAL

Adherence will be assessed using questionnaires at all study visits.

Interventions

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Adherence assessment

Adherence will be assessed using questionnaires at all study visits.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)

Minimum Eligible Age

14 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ruth Tuomala, MD

Role: STUDY_CHAIR

Director of Obstetrics and Gynecology, Brigham and Women's Hospital

Gwen Scott, MD

Role: STUDY_CHAIR

Pediatric Infectious Diseases, University of Miami School of Medicine

Locations

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Univ. of Alabama Birmingham NICHD CRS (5096)

Birmingham, Alabama, United States

Site Status

University of South Alabama

Mobile, Alabama, United States

Site Status

Phoenix Childrens Hospital

Phoenix, Arizona, United States

Site Status

Long Beach Memorial (Pediatric)

Long Beach, California, United States

Site Status

Miller Children's Hospital Long Beach (5093)

Long Beach, California, United States

Site Status

Los Angeles County Medical Center/USC

Los Angeles, California, United States

Site Status

Usc La Nichd Crs (5048)

Los Angeles, California, United States

Site Status

UCLA Med Ctr / Pediatric

Los Angeles, California, United States

Site Status

UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CR (3601)

Los Angeles, California, United States

Site Status

Univ of California, San Diego (4601)

San Diego, California, United States

Site Status

Univ. of California San Francisco NICHD CRS (5091)

San Francisco, California, United States

Site Status

Harbor-UCLA Med Ctr (5045)

Torrance, California, United States

Site Status

University of Colorado Denver NICHD CRS (5052)

Denver, Colorado, United States

Site Status

Connecticut Childrens Medical Center (Pediatric)

Farmington, Connecticut, United States

Site Status

University of Connecticut, Farmington

Farmington, Connecticut, United States

Site Status

Yale Univ School of Med

New Haven, Connecticut, United States

Site Status

Children's National Medical Center Washington DC NICHD CRS (5015)

Washington D.C., District of Columbia, United States

Site Status

Washington Hospital Center NICHD CRS (5023)

Washington D.C., District of Columbia, United States

Site Status

Howard Univ Hosp (5044)

Washington D.C., District of Columbia, United States

Site Status

North Broward Hosp District

Fort Lauderdale, Florida, United States

Site Status

South Florida CDC Ft Lauderdale NICHD CRS (5055)

Fort Lauderdal, Florida, United States

Site Status

University of Florida Jacksonville (5051)

Jacksonville, Florida, United States

Site Status

Jackson Memorial Hosp

Miami, Florida, United States

Site Status

University of Miami Pediatric/Perinatal HIV/AIDS (4201)

Miami, Florida, United States

Site Status

University of South Florida at Tampa (5018)

St. Petersburg, Florida, United States

Site Status

Med College of Georgia

Augusta, Georgia, United States

Site Status