Punctuated Antiretroviral Therapy

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

Information:

Sponsor - U.S. National Institutes of Health
Principal Investigator - Christopher C. Whalen, M.D., M.S., University of Georgia

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 \x96 60 years of age, with active pulmonary TB and a CD4+ count greater than 350 cells/µL
Study Period 2002-2009
Interactions 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 rest 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 Antiretroviral 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.