Routine Use of Antiretroviral Therapy to Prevent Mother-to-Child HIV Transmission in the Kafue District of Zambia
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|ClinicalTrials.gov Identifier: NCT00753324|
Recruitment Status : Completed
First Posted : September 16, 2008
Last Update Posted : March 29, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections||Drug: Routine three-drug antiretroviral prophylaxis||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||284 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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).|
|Study Start Date :||May 2009|
|Actual Primary Completion Date :||January 2012|
|Actual Study Completion Date :||January 2012|
Experimental: 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.
Drug: Routine three-drug antiretroviral prophylaxis
Women who are identified as HIV-infected will be offered routine combination antiretroviral prophylaxis starting at 28 weeks gestation (timing consistent with Zambian national guidelines for short-course ZDV). The first-line combination provided to pregnant women will be standardized following consultation with the Ministry of Health, but will likely include ZDV, lamivudine (3TC) and either NVP or lopinavir / ritonavir. In women who with moderate to severe anemia, ZDV is substituted with stavudine (d4T). In accordance with the Zambian national guidelines, any patients who are started on NVP will begin with a once daily dose for two weeks before increasing to the regular twice daily schedule
No Intervention: Control arm
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.
- HIV Infection [ Time Frame: 12 months ]
- HIV Infection [ Time Frame: 6 weeks, 6 months and 24 months ]
- Infant survival [ Time Frame: 12 and 24 months ]
- HIV-free survival [ Time Frame: 12 months and 24 months ]
- Incidence of maternal toxicity to HAART regimens [ Time Frame: 24 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00753324
|Lusaka, Zambia, 34681|
|Principal Investigator:||Benjamin Chi, M.D||Centre for Infectious Disease Research in Zambia|