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

HIV Infections Clinical Trial

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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00753324
• Other study ID #: CIDRZ 1222/F070821006
• Status: Completed
• Phase: Phase 4
• First received: September 15, 2008
• Last updated: March 25, 2016
• Start date: May 2009
• Est. completion date: January 2012

Study information

• Verified date: March 2016
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: Zambia: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 284
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV Infections

Intervention

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

Locations

Country	Name	City	State
Zambia	CIDRZ	Lusaka

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Doris Duke Charitable Foundation

Country where clinical trial is conducted

Zambia, 

References & Publications (1)

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. 20 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HIV Infection		12 months	No
Secondary	HIV Infection		6 weeks, 6 months and 24 months	No
Secondary	Infant survival		12 and 24 months	No
Secondary	HIV-free survival		12 months and 24 months	No
Secondary	Incidence of maternal toxicity to HAART regimens		24 months	No