Routine Use of Antiretroviral Therapy to Prevent Mother-to-Child HIV Transmission in the Kafue District of Zambia

This study has been completed.
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: September 16, 2014
Last verified: September 2014

September 15, 2008
September 16, 2014
May 2009
January 2012   (final data collection date for primary outcome measure)
HIV Infection [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00753324 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Routine Use of Antiretroviral Therapy to Prevent Mother-to-Child HIV Transmission in the Kafue District of Zambia
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).

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
HIV Infections
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
  • 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.
    Intervention: Drug: Routine three-drug antiretroviral prophylaxis
  • 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.
Gartland MG, Chintu NT, Li MS, Lembalemba MK, Mulenga SN, Bweupe M, Musonda P, Stringer EM, Stringer JS, Chi BH. Field effectiveness of combination antiretroviral prophylaxis for the prevention of mother-to-child HIV transmission in rural Zambia. AIDS. 2013 May 15;27(8):1253-62. doi: 10.1097/QAD.0b013e32835e3937.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
284
January 2012
January 2012   (final data collection date for primary outcome measure)

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
Female
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Zambia
 
NCT00753324
CIDRZ 1222/F070821006
No
Benjamin Chi, MD, MSc, University of North Carolina, Chapel Hill
University of North Carolina, Chapel Hill
Doris Duke Charitable Foundation
Principal Investigator: Benjamin Chi, M.D Centre for Infectious Disease Research in Zambia
University of North Carolina, Chapel Hill
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP