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

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ClinicalTrials.gov Identifier: NCT00002439

Recruitment Status : Completed

First Posted : August 31, 2001

Last Update Posted : June 24, 2005

Sponsor:

Collaborator:

Ligand Pharmaceuticals

Information provided by:

NIH AIDS Clinical Trials Information Service

Study Description

Brief 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 .

Condition or disease	Intervention/treatment	Phase
Sarcoma, Kaposi HIV Infections	Drug: Alitretinoin	Not Applicable

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.

Study Design


Study Type :	Interventional (Clinical Trial)
Primary Purpose:	Treatment
Official Title:	Randomized Phase III Vehicle Controlled Trial of ALRT 1057 Topical Gel in Patients With AIDS-Related Kaposi's Sarcoma

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kaposi Sarcoma Soft Tissue Sarcoma

Drug Information available for: Alitretinoin

Genetic and Rare Diseases Information Center resources: Soft Tissue Sarcoma Kaposi Sarcoma

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Information not available

Contacts and Locations

No Contacts or Locations Provided

More Information

Publications:

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.


ClinicalTrials.gov Identifier:	NCT00002439 History of Changes
Other Study ID Numbers:	272A L1057T-31 96ACR-LIG1
First Posted:	August 31, 2001 Key Record Dates
Last Update Posted:	June 24, 2005
Last Verified:	August 1997

Additional relevant MeSH terms:


HIV Infections Sarcoma Sarcoma, Kaposi Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes	Immune System Diseases Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Herpesviridae Infections DNA Virus Infections Neoplasms, Vascular Tissue Alitretinoin Antineoplastic Agents

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