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

University of North Carolina (UNC)

Status and phase: Completed; Phase 4

Conditions: HIV Infections

Treatments: Drug: Routine three-drug antiretroviral prophylaxis

Study type: Interventional

Funder types: Other

Identifiers

NCT00753324

CIDRZ 1222/F070821006

Details and patient eligibility

About

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.

Enrollment: 284 patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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284 participants in 2 patient groups

Routine three-drug antiretroviral prophyalxis

Experimental group

Description:

Cohort of 160 HIV-infected women, approached at \> 28 weeks gestation and initiated on routine HAART for the purposes of PMTCT.

Treatment:

Drug: Routine three-drug antiretroviral prophylaxis

Control arm

No Intervention group

Description:

A cohort of 160 women will be enrolled from the control clinics, from 28 weeks gestation onward. At these sites, the antenatal zidovudine will be offered, with provision of single-dose nevirapine for self-administration in labor. This practice is in accordance with the current standard of care recommended by the Zambian National Guidelines for PMTCT.