A Pilot, Open-Label, Phase II, Randomized Study to Determine the Effects of Viracept on the Outcome of Cutaneous and Mucosal KS in AIDS Patients With CD4 <= 500 Cells/mm3
- Conditions
- Sarcoma, KaposiHIV Infections
- Registration Number
- NCT00002185
- Lead Sponsor
- Agouron Pharmaceuticals
- Brief Summary
To determine the effect of Viracept in combination with modified antiretroviral therapy on the outcome of cutaneous and mucosal Kaposi's Sarcoma (KS).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (5)
Univ of California / UCI Med Ctr
🇺🇸Orange, California, United States
LAC and USC Med Ctr / School of Medicine
🇺🇸Los Angeles, California, United States
UCSD Treatment Ctr
🇺🇸San Diego, California, United States
Harbor - UCLA Med Ctr - Box 449
🇺🇸Torrance, California, United States
Santa Clara Valley Med Ctr
🇺🇸San Jose, California, United States