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

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.

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

The Gaborone BHP Study Clinic, Gaborone, Botswana

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Sponsors and collaborators

Lead sponsor

Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

Network

Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Registry information

Official study title

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

Important dates

Study start: 2006
Primary completion: 2010
Study completion: 2010
First posted: Jan 7, 2005
Registry last updated: Apr 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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