drugset / Trial / NCT00753324

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

NCT00753324 ↗

RandomizedParallel-groupOpen-labelPrevention

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.

Timeline

Start
2009-05
Primary completion
2012-01
Completion
2012-01

Outcome

Met primary endpoint

paper When we considered the composite outcome of HIV infection or death, similar trends were observed in the overall study population (RR: 3.4, 95% CI: 1.6-7.6; P = 0.002) PMID 23324656 ↗

paper When compared with PMTCT services based on antenatal zidovudine and peripartum nevirapine, the provision of maternal combination prophylaxis imparted measurable health benefits to HIV-exposed infants. PMID 23324656 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Lamivudine Other / unclassified — —
Subject Lopinavir Other / unclassified — —
Subject Nevirapine Small molecule — —
Subject Ritonavir Other / unclassified — —
Subject Stavudine Other / unclassified — —
Subject Zidovudine Small molecule — —