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

This study has been completed.

Sponsor:

Collaborator:

Ligand Pharmaceuticals

Information provided by:

NIH AIDS Clinical Trials Information Service

ClinicalTrials.gov Identifier:

NCT00002439

First received: November 2, 1999

Last updated: June 23, 2005

Last verified: August 1997

History of Changes

Purpose

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	Intervention
Sarcoma, Kaposi HIV Infections	Drug: Alitretinoin


Study Type:	Interventional
Study Design:	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 NLM:

MedlinePlus related topics: HIV/AIDS Kaposi's Sarcoma Soft Tissue Sarcoma

Drug Information available for: Alitretinoin

Genetic and Rare Diseases Information Center resources: Classic Kaposi Sarcoma Malignant Mesenchymal Tumor Soft Tissue Sarcoma

U.S. FDA Resources

Further study details as provided by NIH AIDS Clinical Trials Information Service:

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.

Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Information not available

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
Health Authority:	United States: Food and Drug Administration

ClinicalTrials.gov processed this record on March 03, 2015

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