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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:
Anderson Clinical Research
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
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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:
Further study details as provided by NIH AIDS Clinical Trials Information Service:
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 (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Information not available
Contacts and Locations
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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 |
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 |
ClinicalTrials.gov processed this record on September 21, 2017