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
|Type of Study||Randomized Clinical Trial|
|Design||Phase III open-label, randomized, clinical trial|
|Sample Size||220 HIV-infected patients|
|Population||Adult male or female with active pulmonary TB and a CD4+ count greater than 350 cells/µL|
|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 results 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.