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

This study has been completed.

First Received: November 2, 1999 Last Updated: June 23, 2005 History of Changes

Sponsor:	Anderson Clinical Research
Collaborator:	Ligand Pharmaceuticals
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00002439

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:	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: AIDS Kaposi's Sarcoma Soft Tissue Sarcoma

Drug Information available for: 9-cis-Retinoic acid

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

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.

Study ID Numbers:	272A, L1057T-31, 96ACR-LIG1
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002439 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

RNA Virus Infections
Sexually Transmitted Diseases, Viral
Neoplasms by Histologic Type
Slow Virus Diseases
Alitretinoin
Immune System Diseases
Antineoplastic Agents
Acquired Immunodeficiency Syndrome
Sarcoma, Kaposi
Infection
Pharmacologic Actions
Immunologic Deficiency Syndromes

Herpesviridae Infections
Virus Diseases
Neoplasms, Connective and Soft Tissue
Neoplasms
HIV Infections
Therapeutic Uses
Sexually Transmitted Diseases
Neoplasms, Vascular Tissue
Sarcoma
Lentivirus Infections
DNA Virus Infections
Retroviridae Infections

ClinicalTrials.gov processed this record on November 09, 2009