A Study of ALRT1057 in Patients With AIDS-Related Kaposi's Sarcoma

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to see if ALRT1057 is safe and effective in treating patients with AIDS-related Kaposi's sarcoma (KS).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Anderson Clinical Research
• Collaborator: Ligand Pharmaceuticals
• Treatments: Alitretinoin

Criteria

Inclusion Criteria

Patients must have:

• HIV positive status and histologic confirmation of KS.

• CD4 count > 200 mm3 (required of one-half of patients).

• Minimum of 6 mucocutaneous KS lesions, including at least 3 raised lesions meeting criteria for "indicator" lesions.

• Acceptable organ system function.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

Serious or intercurrent illness or infection that would interfere with the ability of the patient to carry out the treatment program.

Prior Medication:

Excluded:

• Systemic therapy for KS within 30 days.

• Local or topical therapy for KS indicative lesions within 60 days.

• Systemic therapy with vitamin A in doses exceeding 15,000 IU per day or other retinoid class drug.

Required:

Approved antiretroviral therapy.