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: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Parirenyatwa Hospital
• Collaborators: Abbott; GlaxoSmithKline; University of Colorado, Denver
• Treatments: Abacavir; Dideoxynucleosides; Lamivudine; Lopinavir; Ritonavir; Zidovudine

Criteria

Inclusion Criteria:Completion of at least 96 weeks of treatment with ABC/3TC/ZDV on protocol Step 1.

• Currently receiving ABC/3TC/ZDV on Step 1/initial open-label allNRTI phase of study.

• Plasma HIV-1 RNA < 400 copies/mL on the most recent plasma HIV-1 RNA performed within 4 weeks of Step 2 entry.

• Willing to potentially switch to a new antiretroviral regimen.

• In the opinion of the site investigator currently has clinical evidence of active KS disease.

Exclusion Criteria

• None