AIDS-related Kaposi's Sarcoma Clinical Trial
Official title:
A Pilot Study Of the Effects of Highly Active Antiretroviral Therapy on Kaposi's Sarcoma in Zimbabwe
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.
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
ABC/3TC/ZDV.
An important objective is to assess adherence to a simplified antiretroviral regimen in a
resource-limited setting.
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
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT01752569 -
A Study of Selumetinib in Patients With Kaposi's Sarcoma
|
Phase 1/Phase 2 |