Clinical Trials Directory

Trials / Completed

CompletedNCT00002439

A Study of ALRT 1057 Topical Gel in Patients With AIDS-Related Kaposi's Sarcoma

Randomized Phase III Vehicle Controlled Trial of ALRT 1057 Topical Gel in Patients With AIDS-Related Kaposi's Sarcoma

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
—
Sponsor
Anderson Clinical Research · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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 .

Detailed description

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.

Conditions

Interventions

TypeNameDescription
DRUGAlitretinoin

Timeline

First posted
2001-08-31
Last updated
2005-06-24

Source: ClinicalTrials.gov record NCT00002439. Inclusion in this directory is not an endorsement.