Routine Use of Antiretroviral Therapy to Prevent Mother-to-Child HIV Transmission in the Kafue District of Zambia
This study has been terminated.
(Enrollment efforts discontinued because recruitment slower than anticipated.)
Sponsor:
University of North Carolina, Chapel Hill
Collaborator:
Doris Duke Charitable Foundation
Information provided by (Responsible Party):
Benjamin Chi, MD, MSc, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00753324
First received: September 15, 2008
Last updated: May 30, 2012
Last verified: May 2012
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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 | Intervention | Phase |
---|---|---|
HIV Infections |
Drug: Routine three-drug antiretroviral prophylaxis |
Phase 4 |
Study Type: | Interventional |
Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
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). |
Resource links provided by NLM:
Further study details as provided by University of North Carolina, Chapel Hill:
Primary Outcome Measures:
- HIV Infection [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- HIV Infection [ Time Frame: 6 weeks, 6 months and 24 months ] [ Designated as safety issue: No ]
- Infant survival [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
- HIV-free survival [ Time Frame: 12 months and 24 months ] [ Designated as safety issue: No ]
- Incidence of maternal toxicity to HAART regimens [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Enrollment: | 284 |
Study Start Date: | May 2009 |
Study Completion Date: | January 2012 |
Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
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.
|
![](https://webarchive.library.unt.edu/web/20130317075911im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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
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![](https://webarchive.library.unt.edu/web/20130317075911im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
No publications provided
Responsible Party: | Benjamin Chi, MD, MSc, Associate Professor, University of North Carolina, Chapel Hill |
ClinicalTrials.gov Identifier: | NCT00753324 History of Changes |
Other Study ID Numbers: | F070821006 |
Study First Received: | September 15, 2008 |
Last Updated: | May 30, 2012 |
Health Authority: | Zambia: Ministry of Health |
Keywords provided by University of North Carolina, Chapel Hill:
PMTCT HAART Pregnancy |
HIV Infection HIV Transmission HIV Seronegativity |
Additional relevant MeSH terms:
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
ClinicalTrials.gov processed this record on March 14, 2013