Back to resultsA Study of ALRT 1057 Topical Gel in Patients With AIDS-Related Kaposi's Sarcoma
Primary Purpose
Sarcoma, Kaposi, HIV Infections
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Alitretinoin
Sponsored by
About this trial
This is an interventional treatment trial for Sarcoma, Kaposi
Eligibility Criteria
Information not available
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00002439
First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Anderson Clinical Research
Collaborators
Ligand Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00002439
Brief Title
A Study of ALRT 1057 Topical Gel in Patients With AIDS-Related Kaposi's Sarcoma
Official Title
Randomized Phase III Vehicle Controlled Trial of ALRT 1057 Topical Gel in Patients With AIDS-Related Kaposi's Sarcoma
Study Type
Interventional
2. Study Status
Record Verification Date
August 1997
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Anderson Clinical Research
Collaborators
Ligand Pharmaceuticals
4. Oversight
5. Study Description
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 .
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoma, Kaposi, HIV Infections
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Alitretinoin
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Information not available
12. IPD Sharing Statement
Citations:
PubMed Identifier
10770343
Citation
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. doi: 10.1097/00126334-199911010-00004.
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A Study of ALRT 1057 Topical Gel in Patients With AIDS-Related Kaposi's Sarcoma
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