A Pilot Study Of the Effects of Highly Active Antiretroviral Therapy on Kaposi's Sarcoma in Zimbabwe
To identify factors associated with successful treatment of KS with antiretroviral therapy
and to determine if highly active antiretroviral therapy improves survival and quality of
life for persons with AIDS-KS in Zimbabwe.
A secondary objective is to investigate the durability of HIV-1 suppression by the
combination of ABC/3TC/ZDV in persons infected with HIV-1 subtype C and to evaluate the
timing and characteristics of mutations in HIV-1 reverse transcriptase in subjects who fail
to achieve, or to maintain suppression of HIV-1 replication during treatment with
An important objective is to assess adherence to a simplified antiretroviral regimen in a
The study will evaluate the clinical, immunological, and virological effects of a switch
from a twice-daily all-nucleoside reverse transcriptase inhibitor (NRTI) antiretroviral
regimen to a once-daily regimen of 2 NRTIs plus a ritonavir-boosted protease inhibitor in
persons with AIDS-KS and good virologic suppression on ABC/3TC/ZDV (see above).
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Compare effects of twice-daily all-(NRTI) antiretroviral regimen to a once-daily regimen of 2 NRTIs plus a protease inhibitor AIDS-KS subjects with good virologic suppression on all-NRTI regimen.
Margaret Z Borok, FRCP
University of Zimbabwe College of Health Sciences Department of Medicine
Zimbabwe: Medical Research Council