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

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00753324

First Posted: September 16, 2008

Last Update Posted: March 29, 2016

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Collaborator:

Doris Duke Charitable Foundation

Information provided by (Responsible Party):

Benjamin Chi, MD, MSc, University of North Carolina, Chapel Hill

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 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).

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

Further study details as provided by Benjamin Chi, MD, MSc, University of North Carolina, Chapel Hill:

Primary Outcome Measures:

HIV Infection [ Time Frame: 12 months ]

Secondary Outcome Measures:

HIV Infection [ Time Frame: 6 weeks, 6 months and 24 months ]
Infant survival [ Time Frame: 12 and 24 months ]
HIV-free survival [ Time Frame: 12 months and 24 months ]
Incidence of maternal toxicity to HAART regimens [ Time Frame: 24 months ]


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.

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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

Publications:

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.


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 Submitted:	September 15, 2008
First Posted:	September 16, 2008
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

To Top