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

NCT00753324 | Completed Phase 4

• 1 other identifier: CIDRZ 1222/F070821006
• Study Type: interventional
• Target: 284
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections

Keywords

PMTCT; HAART; Pregnancy; HIV Infection; HIV Transmission; HIV Seronegativity

Outcome Measures

Primary Outcomes (1)

• HIV Infection

  12 months

Secondary Outcomes (4)

• HIV Infection

  6 weeks, 6 months and 24 months

• Infant survival

  12 and 24 months

• HIV-free survival

  12 months and 24 months

• Incidence of maternal toxicity to HAART regimens

  24 months

Study Arms (2)

Routine three-drug antiretroviral prophyalxis

EXPERIMENTAL

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

Control arm

NO INTERVENTION

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.

Interventions

Routine three-drug antiretroviral prophylaxis DRUG

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

Routine three-drug antiretroviral prophyalxis

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV infected
• Pregnant women
• Ability to provide informed consent.
• Meets eligibility criteria for HAART initiation

You may not qualify if:

• Unwillingness to provide informed consent
• Below the age of legal consent

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Doris Duke Charitable Foundation: collaborator

Study Sites (1)

CIDRZ

Lusaka, Lusaka Province, 34681, Zambia

Location

Related 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. 2013 May 15;27(8):1253-62. doi: 10.1097/QAD.0b013e32835e3937.

  PMID: 23324656 RESULT

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Benjamin Chi, M.D

  Centre for Infectious Disease Research in Zambia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 15, 2008
• First Posted: September 16, 2008
• Study Start: May 1, 2009
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: March 29, 2016

Record last verified: 2016-03

Locations

ZA (1)