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
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.
Interventional
Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment
United States: Food and Drug Administration
259F
NCT00002185
Name | Location |
---|---|
LAC and USC Med Ctr / School of Medicine | Los Angeles, California 90033 |
Univ of California / UCI Med Ctr | Orange, California 92868 |
UCSD Treatment Ctr | San Diego, California 92103 |
Santa Clara Valley Med Ctr | San Jose, California 951282699 |
Harbor - UCLA Med Ctr - Box 449 | Torrance, California 90509 |