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| Sponsors and Collaborators: |
Anderson Clinical Research 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 |
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 |
Information not available
Contacts and Locations More Information
| Study ID Numbers: | 272A, L1057T-31, 96ACR-LIG1 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002439 |
| Health Authority: | United States: Food and Drug Administration |
|
Sexually Transmitted Diseases, Viral Alitretinoin Malignant mesenchymal tumor Acquired Immunodeficiency Syndrome Sarcoma, Kaposi Soft tissue sarcomas Immunologic Deficiency Syndromes Herpesviridae Infections |
Virus Diseases Neoplasms, Connective and Soft Tissue Kaposi sarcoma HIV Infections Sexually Transmitted Diseases Sarcoma DNA Virus Infections Retroviridae Infections |
|
Neoplasms RNA Virus Infections Neoplasms by Histologic Type Slow Virus Diseases Immune System Diseases Antineoplastic Agents |
Therapeutic Uses Neoplasms, Vascular Tissue Lentivirus Infections Infection Pharmacologic Actions |
