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NCT00002439 Clinical Trial

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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00002439
Other study ID # 272A
Secondary ID L1057T-3196ACR-L
Status Completed
Phase N/A
First received November 2, 1999
Last updated June 23, 2005

Study information
Verified date August 1997
Source NIH AIDS Clinical Trials Information Service
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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 .

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.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Information not available

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Alitretinoin

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Anderson Clinical Research Ligand Pharmaceuticals

References & Publications (1)

Walmsley S, Northfelt DW, Melosky B, Conant M, Friedman-Kien AE, Wagner B. Treatment of AIDS-related cutaneous Kaposi's sarcoma with topical alitretinoin (9-cis-retinoic acid) gel. Panretin Gel North American Study Group. J Acquir Immune Defic Syndr. 1999 Nov 1;22(3):235-46. — View Citation

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