Effects of Maternal Anti-HIV Treatment on Infants Born to HIV-Infected Women
- Conditions
- HIV Infections
- Registration Number
- NCT00100867
- Lead Sponsor
- Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 236
- 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
- Infant with no exposure to antiretrovirals OR who received only intrapartum antiretroviral exposure
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (23)
Hospital dos Servidores do Estado
🇧🇷Rio de Janeiro, Brazil
Univ. of Malawi, John Hopkins Project
🇲🇼Blantyre, Malawi
Phayao Provincial Hospital, Phayao
🇹ðŸ‡Tambol Mae Sai, Muang Phayao, Thailand
Chiang Mai University
🇹ðŸ‡Chang Mai, Thailand
Prapokklao Hospital Chantaburi
🇹ðŸ‡Muang Chantaburi, Thailand
The Gaborone BHP Study Clinic
🇧🇼Gaborone, Botswana
Instituto de Pesquisa Clinica Evandro Chagas Fiocruz, Fundacao Oswaldo Cruz
🇧🇷Rio de Janeiro,, Brazil
NARI-NIV Clinic
🇮🇳Pune, India
Asociacion Civil IMPACTA Salud y Educacion,
🇵🇪Miraflores, Lima, Peru
The Molepolole BHP Study Clinic
🇧🇼Gaborone, Botswana
NARI AIDS Research Institute, Department of Clinical Science
🇮🇳Pune, India
University of North Carolina Project (UNC Project)
🇲🇼Lilongwe, Malawi
University of Zimbabwe
🇿🇼Harare, Zimbabwe
Hospital Geral de Nova Iguacu
🇧🇷Rio de Janeiro, Brazil
YRG Center for AIDS Research and Education
🇮🇳Chennai, India
Asociacion Civil IMPACTA Salud y Educacion, Lince
🇵🇪Lima, Peru
Siriraj Hospital
🇹ðŸ‡Bangkok Noi, Bankok, Thailand
Bhumibol Adulyadej Hospital, Bangkok
🇹ðŸ‡Bangkok, Thailand
NARI AIDS Research Institute, Dr. Kotnis Dispensary
🇮🇳Pune, India
Chonburi Regional Hospital, Chonburi
🇹ðŸ‡Muang, Chonburi, Thailand
Perinatal HIV Research Unit at Chris Baragwanath Hospital
🇿🇦Johannesburg, South Africa
University of the Witwatersrand
🇿🇦Johannesburg, South Africa
Institut de Recherche pour Developpement (IRD)
🇹ðŸ‡Chiang Mai, Thailand