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Case Western Reserve University Tuberculosis Research Unit
  Integrating research to combat the global TB epidemic
 
 

Delaying HIV Disease Progression with Punctuated Antiretroviral Therapy in Patients with Tuberculosis in Uganda (PART)

Sponsor U.S. National Institutes of Health
(Principal Investigator - Christopher C. Whalen, M.D., M.S., University of Georgia; Co-Investigator - C. Scott Mahan, M.D., CWRU)

Type of Study

Randomized Clinical Trial

Design

Phase III open-label, randomized, clinical trial

Project Site

Uganda

Sample Size

220 HIV-infected patients

Population

Adult male or female, 13 60 years of age, with active pulmonary TB and a CD4+ count greater than 350 cells/µL

Study Period

2002-2009

Interactions With TBRU

Collaborating investigators and staff, utilizing shared project management infrastructure

Goal of Study:

To determine whether a punctuated six-month course of ARV therapy during treatment of active TB will delay HIV disease progression, as measured by time until CD4+ count falls below 250 cells/µL, the rate of decline in CD4+ cell counts, and incidence of opportunistic infections, among HIV-infected persons with active TB and CD4+ cell count above 350 cells/µL.

Objectives of Study:

PART study is a prospective randomized, open-label, phase III clinical trial in Uganda, Kampala designed primarily to determine whether a punctuated six-month course of ARV therapy during treatment of active TB will delay HIV disease progression among HIV-infected persons with active TB and CD4+ cell count above 350 cells/µL. The study has completed randomization of 220 eligible patients with active TB and a CD4+ count greater than 350 cells/µL receiving either immediate sixth-month punctuated course of ARV therapy (N=110) or delayed ARV therapy (N=110 patients) in a 1:1 manner. The delayed ARV treatment is started when the CD4+ count drops below 250 cells/µL.

Patients are followed for a minimum of 6 months from study enrollment. The total study duration is 6 years. The primary study endpoints are defined as time until CD4+ count falls below 250 cells/µL, the rate of decline in CD4+ cell counts, incidence of opportunistic infections, and or death.

The restls of this completed study can be found in:

Nanteza MW, Mayanja-Kizza H, Charlebois E, Srikantiah P, Lin R, Mupere E, Mugyenyi P, Boom WH, Mugerwa RD, Havlir DA, Whalen CC.  A Randomized Clinical Trial of a 6-Month Punctuated Course of Antiretorviral Therapy In Ugandan HIV Seropositive Adults with Pulmonary Tuberculosis and CD4+ T Cell Count > 350 cells/mL.  J Inf Dis, 204:884-92, 2011. PMCID: PMC3156928.

Abstract (PubMed)