A Randomized Comparison of Protease Inhibitor-based Versus Non-nucleoside Reverse Transcriptase Inhibitor-based Antiretroviral Therapy for Initial Treatment of Individuals With AIDS-related Kaposi's Sarcoma in Sub-Saharan Africa
With the advent of the HIV epidemic, Kaposi's sarcoma (KS) is now the most common adult
cancer in many parts of sub-Saharan Africa. In HIV-infected patients with KS in developed
settings, the initiation of highly active anti-retroviral therapy (HAART) has been
associated with regression of the tumor, in many but not all cases, even in the absence of
conventional chemotherapy. However, it is not known which specific antiretroviral drugs or
regimens are critical to convey HAART's anti-KS effect. In particular, it is not known
whether the anti-KS effects of protease inhibitors (PI) in vitro and in animal models
translate into improved clinical outcomes as compared to non-PI-based HAART regimens. To
address this, we will determine whether a PI-based HAART regimen (lopinavir/ritonavir plus
emtricitabine/tenofovir) is superior to a non-nucleoside reverse transcriptase inhibitor
(NNRTI)-based HAART regimen (efavirenz plus emtricitabine/tenofovir) in promoting the
regression of KS tumor burden in persons with AIDS-related KS in sub-Saharan Africa. We will
enroll 224 patients with AIDS-related KS in Kampala, Uganda, randomly assign them to either
a PI-based HAART or an NNRTI-based HAART regimen, and observe them for one year to determine
the response in their KS to therapy.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Blinded assessment of the change in the burden of KS lesions
survival
Dr. Jeffrey N Martin, MD, MPH
Principal Investigator
University of California, San Francisco
United States: Institutional Review Board
NIH/NCI Grant #: R01 CA119903
NCT00444379
April 2007
July 2012
Name | Location |
---|