A Pilot Study Of the Effects of Highly Active Antiretroviral Therapy on Kaposi's Sarcoma in Zimbabwe
18 Years
N/A
Both
AIDS-Related Kaposi's Sarcoma
Trial Information
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
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).
Inclusion Criteria:
Completion of at least 96 weeks of treatment with ABC/3TC/ZDV onprotocol 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
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.
Outcome Time Frame:
96 weeks
Safety Issue:
Yes
Principal Investigator
Margaret Z Borok, FRCP
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Zimbabwe College of Health Sciences Department of Medicine
Authority:
Zimbabwe: Medical Research Council
Study ID:
COL30512
NCT ID:
NCT00834457
Start Date:
June 2007
Completion Date:
July 2009
Related Keywords:
- AIDS-Related Kaposi's Sarcoma
- AIDS-related Kaposi's sarcoma
- antiretroviral therapy
- Sarcoma, Kaposi
- AIDS-Related Opportunistic Infections
- Sarcoma
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