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:
Anderson Clinical Research
Collaborator:
Ligand Pharmaceuticals
Information provided by:
NIH AIDS Clinical Trials Information Service
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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 |
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 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

Drug Information available for:
Alitretinoin
U.S. FDA Resources
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
No Contacts or Locations Provided
Publications:
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 |