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

Sponsor:	University of Alabama at Birmingham
Collaborator:	Doris Duke Charitable Foundation
Information provided by:	University of Alabama at Birmingham
ClinicalTrials.gov Identifier:	NCT00753324

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: HAART Drug: zidovudine and nevirapine	Phase IV

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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: AIDS AIDS and Pregnancy

Drug Information available for: Zidovudine Nevirapine

U.S. FDA Resources

Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:

HIV Infection [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	320
Study Start Date:	May 2009
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	July 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Cohort of 160 HIV-infected women, approached at > 32 weeks gestation and initiated on routine HAART for the purposes of PMTCT.	Drug: HAART Women who are identified as HIV-infected will be offered routine HAART starting at 32 weeks gestation (consistent with Zambian national guidelines for short-course ZDV 39). 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
2: Active Comparator A cohort of 160 women will be enrolled from the control clinics, from 32 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.	Drug: zidovudine and nevirapine Antenatal zidovudine will be offered from 32 weeks gestation, with provision of single-dose nevirapine.

Arms

Assigned Interventions

1: Experimental

Cohort of 160 HIV-infected women, approached at > 32 weeks gestation and initiated on routine HAART for the purposes of PMTCT.

Drug: HAART

Women who are identified as HIV-infected will be offered routine HAART starting at 32 weeks gestation (consistent with Zambian national guidelines for short-course ZDV 39). 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

2: Active Comparator

A cohort of 160 women will be enrolled from the control clinics, from 32 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.

Drug: zidovudine and nevirapine

Antenatal zidovudine will be offered from 32 weeks gestation, with provision of single-dose nevirapine.

Eligibility

Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00753324

Contacts

Contact: Benjamin Chi, M.D.

00260 966 859179

Benjamin.Chi@cidrz.org

Locations

Zambia
CIDRZ	Recruiting
Lusaka, Zambia, 34681
Contact: Benjamin Chi, M.D. 00260 966 859179 Benjamin.Chi@cidrz.org
Principal Investigator: Benjamin Chi, M.D.

Sponsors and Collaborators

University of Alabama at Birmingham

Doris Duke Charitable Foundation

Investigators

Principal Investigator:

Benjamin Chi, M.D

CIDRZ

More Information

No publications provided

Responsible Party:	CIDRZ ( Benjamin Chi, MD )
Study ID Numbers:	F070821006
Study First Received:	September 15, 2008
Last Updated:	November 12, 2009
ClinicalTrials.gov Identifier:	NCT00753324 History of Changes
Health Authority:	Zambia: Ministry of Health

Keywords provided by University of Alabama at Birmingham:

PMTCT
HAART
Pregnancy

HIV Infection
HIV Transmission
HIV Seronegativity

Additional relevant MeSH terms:

Antimetabolites
Communicable Diseases
Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Zidovudine
Infection
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Retroviridae Infections
Nucleic Acid Synthesis Inhibitors

RNA Virus Infections
Anti-HIV Agents
Immune System Diseases
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Antiviral Agents
Immunologic Deficiency Syndromes
Pharmacologic Actions
Virus Diseases
Nevirapine
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections

ClinicalTrials.gov processed this record on February 08, 2010