A Pilot Study Of the Effects of Highly Active Antiretroviral Therapy on Kaposi's Sarcoma in Zimbabwe
Status:
Completed
Trial end date:
2009-07-01
Target enrollment:
Participant gender:
Summary
Open-label study of a regimen of antiretrovirals for the treatment of AIDS-KS. This study
will be conducted at a single site, the Parirenyatwa Hospital KS Clinic.
Step 1 was conducted to determine the extent of clinical resolution of AIDS-KS disease in
response to treatment with antiretroviral therapy and to investigate whether clinical
resolution of KS is associated with suppression of KSHV replication.
Step 2 was developed to then 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 an all NRTI regimen.
Step 3 was included to evaluate the clinical, immunological, and virological effects of
intensification with a ritonavir-boosted protease inhibitor in persons with AIDS-KS who have
virological failure on an all NRTI regimen.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
Parirenyatwa Hospital
Collaborators:
Abbott GlaxoSmithKline University of Colorado, Denver