Compassionate Use Study of Two Dose Levels of Thalidomide in Adults With HIV Wasting Syndrome

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

Summary

To allow patients with HIV-associated wasting to receive thalidomide treatment at 1 of 2 doses. To gain safety and efficacy data from a broader base of patients with HIV-associated wasting in order to support Celgene's pivotal placebo-controlled study.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Celgene Corporation
• Treatments: Thalidomide

Criteria

Inclusion Criteria

Concurrent Medication:

Allowed:

• Antiretroviral therapy.

• Prophylaxis or treatment for opportunistic infection.

Patients must have:

HIV-associated wasting.

Prior Medication:

Allowed:

• Prior enrollment on Celgene's placebo-controlled thalidomide study, provided patient meets specified criteria for not continuing on that study.