To determine the effect of Viracept in combination with modified antiretroviral therapy on the outcome of cutaneous and mucosal Kaposi's Sarcoma (KS).
This is an open-label, randomized, pilot, Phase II study of the safety and efficacy of Viracept in combination with modified antiretroviral therapy as treatment in patients with cutaneous and mucosal KS. Patients will be randomized to modify (add or switch or initiate) their current antiretroviral therapy and will add Viracept or remain on their current background antiretroviral therapy for a 2 month period. Initially 20 patients will be randomized in a 2:1 ratio (i.e., 14 Viracept, 6 control) for a 2 month period. Response to therapy will be evaluated at the end of the 2 month control phase. At this point, patients who were initially assigned to the control arm will continue on open label Viracept for an additional 10 month period.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Enrollment
20
LAC and USC Med Ctr / School of Medicine
Los Angeles, California, United States
Univ of California / UCI Med Ctr
Orange, California, United States
UCSD Treatment Ctr
San Diego, California, United States
Santa Clara Valley Med Ctr
San Jose, California, United States
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Harbor - UCLA Med Ctr - Box 449
Torrance, California, United States