A Pilot Study Of the Effects of Highly Active Antiretroviral Therapy on Kaposi's Sarcoma in Zimbabwe
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.
Timeline
- Start
- 2007-06
- Primary completion
- 2009-07
- Completion
- 2009-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Abacavir | Other / unclassified | 300 mg | Oral |
| Comparator | Abacavir | Other / unclassified | 600 mg | Oral |
| Comparator | Lamivudine | Other / unclassified | 150 mg | Oral |
| Comparator | Lamivudine | Other / unclassified | 300 mg | Oral |
| Comparator | Lopinavir | Other / unclassified | 133.3 mg | Oral |
| Comparator | Ritonavir | Other / unclassified | 33.3 mg | Oral |
| Comparator | Zidovudine | Small molecule | 300 mg | Oral |