Status:
COMPLETED
A Pilot Study Of the Effects of Highly Active Antiretroviral Therapy on Kaposi's Sarcoma in Zimbabwe
Lead Sponsor:
Parirenyatwa Hospital
Collaborating Sponsors:
University of Colorado, Denver
GlaxoSmithKline
Conditions:
AIDS-related Kaposi's Sarcoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief 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 th...
Detailed Description
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 wi...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT00834457
Start Date
June 1 2007
End Date
July 1 2009
Last Update
October 30 2014
Active Locations (1)
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1
University of Zimbabwe College of Health Sciences Department of Medicine
Harare, Zimbabwe