The purpose of this study is to see if ALRT1057 gel is safe and effective in treating Kaposi's sarcoma (KS) when applied to skin .

Condition	Treatment or Intervention
Sarcoma, Kaposi HIV Infections	Drug: Alitretinoin

Further Study Details: 

This is a Phase 3 double-blind study. KS patients are randomized to 1 of 2 treatment arms. They receive either ALRT1057 gel or placebo for 12 weeks. If progressive disease for KS is noted before Week 12, patients are switched to the other blinded treatment arm. If a response or disease progression that has not persisted for at least 4 weeks as of Week 12 occurs, treatment on the blinded arm is continued for up to 4 additional weeks, or until response of disease progression is confirmed. After that time or after 12 weeks of treatment, open-label ALRT1057 may be received.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Information not available

Study ID Numbers:  272A; L1057T-31; 96ACR-LIG1
Record last reviewed:  August 1997
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00002439
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08