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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
Sponsor:
Collaborator:
Doris Duke Charitable Foundation
Information provided by (Responsible Party):
Benjamin Chi, MD, MSc, University of North Carolina, Chapel Hill

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.


Condition or disease Intervention/treatment Phase
HIV Infections Drug: Routine three-drug antiretroviral prophylaxis Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 284 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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).
Study Start Date : May 2009
Actual Primary Completion Date : January 2012
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. HIV Infection [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. HIV Infection [ Time Frame: 6 weeks, 6 months and 24 months ]
  2. Infant survival [ Time Frame: 12 and 24 months ]
  3. HIV-free survival [ Time Frame: 12 months and 24 months ]
  4. Incidence of maternal toxicity to HAART regimens [ Time Frame: 24 months ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Senior
Sexes 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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Information from the National Library of Medicine

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


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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

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
First Posted: September 16, 2008    Key Record Dates
Last Update Posted: March 29, 2016
Last Verified: March 2016

Keywords provided by Benjamin Chi, MD, MSc, University of North Carolina, Chapel Hill:
PMTCT
HAART
Pregnancy
 HIV Infection
HIV Transmission
HIV Seronegativity

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
 Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases