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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:
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
History of Changes
  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:

U.S. FDA Resources

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
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 CIDRZ
  More Information

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 May 21, 2013