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

NCT00100867 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 236

Last updated 2016-04-01

No results posted yet for this study

Summary

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.

Conditions

  • HIV Infections

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

    lead NETWORK

Principal Investigators

  • Karin Nielsen, MD, MPH · University of California, Los Angeles

  • Judith S. Currier, MD, MSc · Center for AIDS Research and Education, University of California, Los Angeles

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-06-30
Primary Completion
2010-05-31
Completion
2010-05-31

Countries

  • Botswana
  • Brazil
  • India
  • Malawi
  • Peru
  • South Africa
  • Thailand
  • Zimbabwe

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00100867 on ClinicalTrials.gov