Routine Use of Antiretroviral Therapy to Prevent Mother-to-Child HIV Transmission in the Kafue District of Zambia

Phase 4

Completed

• Conditions: HIV Infections
• Interventions: Drug: Routine three-drug antiretroviral prophylaxis

• Registration Number: NCT00753324
• Lead Sponsor: University of North Carolina, Chapel Hill

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-09-15
• Study First Submitted QC: 2008-09-15
• Study First Posted: 2008-09-16
• Study Start: 2009-05
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-25
• Last Update Posted: 2016-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 284

Inclusion Criteria

• HIV infected
• Pregnant women
• Ability to provide informed consent.
• Meets eligibility criteria for HAART initiation

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Exclusion Criteria

• Unwillingness to provide informed consent
• Below the age of legal consent

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Routine three-drug antiretroviral prophyalxis	Routine three-drug antiretroviral prophylaxis	Cohort of 160 HIV-infected women, approached at \> 28 weeks gestation and initiated on routine HAART for the purposes of PMTCT.

Primary Outcome Measures

Name	Time	Method
HIV Infection	12 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

CIDRZ; 🇿🇲 Lusaka, Zambia