Routine Use of Antiretroviral Therapy to Prevent Mother-to-Child HIV Transmission in the Kafue District of Zambia (Impact of HAART to Prevent Pediatric AIDS in Rural Zambia).
Overview
- Phase
- Phase 4
- Intervention
- Routine three-drug antiretroviral prophylaxis
- Conditions
- HIV Infections
- Sponsor
- University of North Carolina, Chapel Hill
- Enrollment
- 284
- Locations
- 1
- Primary Endpoint
- HIV Infection
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
The investigators will enroll a cohort of HIV-infected pregnant women accessing PMTCT services, to better understand the incremental benefits (e.g. reduction in HIV transmission, improvements in HIV-free survival) and risks (e.g. drug toxicities) of the routine HAART strategy, in comparison to HIV-infected pregnant women accessing the Zambian Standard of Care services.
The investigators will test the hypothesis that routine use of HAART produces significant reductions in HIV transmission rates, with only minimal side effects.
Investigators
Benjamin Chi, MD, MSc
Associate Professor
University of North Carolina, Chapel Hill
Eligibility Criteria
Inclusion Criteria
- •HIV infected
- •Pregnant women
- •Ability to provide informed consent.
- •Meets eligibility criteria for HAART initiation
Exclusion Criteria
- •Unwillingness to provide informed consent
- •Below the age of legal consent
Arms & Interventions
Routine three-drug antiretroviral prophyalxis
Cohort of 160 HIV-infected women, approached at \> 28 weeks gestation and initiated on routine HAART for the purposes of PMTCT.
Intervention: Routine three-drug antiretroviral prophylaxis
Outcomes
Primary Outcomes
HIV Infection
Time Frame: 12 months
Secondary Outcomes
- HIV Infection(6 weeks, 6 months and 24 months)
- Infant survival(12 and 24 months)
- HIV-free survival(12 months and 24 months)
- Incidence of maternal toxicity to HAART regimens(24 months)