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A Study of ALRT 1057 Topical Gel in Patients With AIDS-Related Kaposi's Sarcoma

NCT ID: NCT00002439

Last Updated: 2005-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Brief Summary

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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

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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.

Conditions

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Sarcoma, Kaposi HIV Infections

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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Alitretinoin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Information not available
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ligand Pharmaceuticals

INDUSTRY

Sponsor Role collaborator

Anderson Clinical Research

INDUSTRY

Sponsor Role lead

References

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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.

Reference Type BACKGROUND
PMID: 10770343 (View on PubMed)

Other Identifiers

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L1057T-31

Identifier Type: -

Identifier Source: secondary_id

96ACR-LIG1

Identifier Type: -

Identifier Source: secondary_id

272A

Identifier Type: -

Identifier Source: org_study_id