Routine Use of Antiretroviral Therapy to Prevent Mother-to-Child HIV Transmission in the Kafue District of Zambia
This study has been completed.
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: September 16, 2014
Last verified: September 2014
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Purpose
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.
|
Eligibility| 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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00753324
Please refer to this study by its ClinicalTrials.gov identifier: NCT00753324
Locations
| Zambia | |
| CIDRZ | |
| Lusaka, Zambia, 34681 | |
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Doris Duke Charitable Foundation
Investigators
| Principal Investigator: | Benjamin Chi, M.D | Centre for Infectious Disease Research in Zambia |
More Information
Publications:
| 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: | CIDRZ 1222/F070821006 |
| Study First Received: | September 15, 2008 |
| Last Updated: | September 16, 2014 |
| 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 Immune System Diseases Immunologic Deficiency Syndromes Lentivirus Infections RNA Virus Infections |
Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Virus Diseases |
ClinicalTrials.gov processed this record on February 27, 2015