Effects of Maternal Anti-HIV Treatment on Infants Born to HIV-Infected Women

March 31, 2016 updated by: AIDS Clinical Trials Group

Assessment of Safety and Toxicity Among Infants Born to HIV-1-Infected Women Enrolled in Antiretroviral Treatment Protocols in Diverse Areas of the World

In clinical trials being conducted throughout the world, pregnant HIV-infected women are given anti-HIV drugs before, during, and after they give birth to prevent mother-to-child transmission of HIV. However, the effects of this anti-HIV treatment on infants is unknown. The purpose of this study is to determine the safety, toxicity, and potential side effects of maternal anti-HIV treatment on infants born to these HIV-infected women.

Study hypothesis: Specific combination antiretroviral regimens used in clinical trials in diverse areas of the world are safe and well tolerated during pregnancy and breastfeeding periods, and are not associated with adverse side effects to the fetus, neonate, and/or breastfeeding infant. These regimens are associated with reduction of mother-to-child HIV transmission.

Study Overview

Status

Completed

Conditions

Detailed Description

Many HIV-infected women outside the United States enroll in clinical trials that provide them antiretroviral therapy (ART) to prevent mother-to-child transmission of HIV. However, data are limited on the safety, toxicity, and adverse effects that maternal ART may have on infants born to HIV-infected women. This study will monitor the adverse effects and potential benefits of maternal ART on these infants.

No antiretrovirals will be given in this study. This study will last 18 months. Infants will be enrolled in the study within 48 hours of birth. There will be 6 study visits starting at study entry and every 6 weeks thereafter. Infants will undergo blood and urine collection, and medical history assessments will occur at every visit. Mothers will also be evaluated at these visits.

Study Type

Observational

Enrollment (Actual)

236

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Botswana
      • Gaborone, Botswana
        • The Gaborone BHP Study Clinic
      • Gaborone, Botswana
        • The Molepolole BHP Study Clinic
  • Brazil
      • Rio de Janeiro, Brazil, 22261-161
        • Hospital dos Servidores do Estado
      • Rio de Janeiro, Brazil
        • Hospital Geral de Nova Iguaçu
      • Rio de Janeiro,, Brazil, 21045-900
        • Instituto de Pesquisa Clinica Evandro Chagas Fiocruz, Fundacao Oswaldo Cruz
  • India
      • Chennai, India, 60001-7
        • YRG Center for AIDS Research and Education
      • Pune, India
        • NARI AIDS Research Institute, Department of Clinical Science
      • Pune, India
        • NARI AIDS Research Institute, Dr. Kotnis Dispensary
      • Pune, India
        • NARI-NIV Clinic
  • Malawi
      • Blantyre, Malawi
        • Univ. of Malawi, John Hopkins Project
      • Lilongwe, Malawi
        • University of North Carolina Project (UNC Project)
  • Peru
      • Lima, Peru, 18
        • Asociacion Civil IMPACTA Salud y Educacion, Lince
    • Lima
      • Miraflores, Lima, Peru, 18
        • Asociacion Civil IMPACTA Salud y Educacion,
  • South Africa
      • Johannesburg, South Africa
        • University of the Witwatersrand
      • Johannesburg, South Africa
        • Perinatal HIV Research Unit at Chris Baragwanath Hospital
  • Thailand
      • Bangkok, Thailand, 10120
        • Bhumibol Adulyadej Hospital, Bangkok
      • Chang Mai, Thailand
        • Chiang Mai University
      • Chiang Mai, Thailand, 50200
        • Institut de Recherche pour Developpement (IRD)
      • Muang Chantaburi, Thailand, 22000
        • Prapokklao Hospital Chantaburi
    • Bankok
      • Bangkok Noi, Bankok, Thailand, 10700
        • Siriraj Hospital
    • Chonburi
      • Muang, Chonburi, Thailand, 20000
        • Chonburi Regional Hospital, Chonburi
    • Muang Phayao
      • Tambol Mae Sai, Muang Phayao, Thailand, 56000
        • Phayao Provincial Hospital, Phayao
  • Zimbabwe
      • Harare, Zimbabwe
        • University of Zimbabwe

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Infants born to HIV-infected women

Description

Inclusion Criteria:

  • Infant born to HIV-1 infected mother enrolled in NIH-sponsored, international antiretroviral treatment trial AND who has had either in utero or postpartum antiretroviral exposure
  • Parent or guardian willing to provide informed consent

Exclusion Criteria:

  • Infant with no exposure to antiretrovirals OR who received only intrapartum antiretroviral exposure

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AIDS Clinical Trials Group

Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

  • Study Chair: Judith S. Currier, MD, MSc, Center for AIDS Research and Education, University of California, Los Angeles
  • Study Chair: Karin Nielsen, MD, MPH, University of California, Los Angeles

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

January 6, 2005

First Submitted That Met QC Criteria

January 6, 2005

First Posted (Estimate)

January 7, 2005

Study Record Updates

Last Update Posted (Estimate)

April 1, 2016

Last Update Submitted That Met QC Criteria

March 31, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACTG A5190-P1054
  • 1U01AI068636 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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