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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:

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:

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

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Sarcoma, Kaposi
AIDS-Related Opportunistic Infections
Sarcoma
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
 Herpesviridae Infections
DNA Virus Infections
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Vascular Tissue
Opportunistic Infections
Infection
Parasitic Diseases
Alitretinoin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 21, 2013