A Phase II, Parallel Group, Randomized, Placebo-Controlled Study of the Safety and Efficacy of Thalidomide in Reducing Weight Loss in Adults With HIV Wasting Syndrome

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

Summary

To evaluate the safety, antiviral and anti-TNF-alpha activity, and preliminary efficacy of thalidomide in reducing weight loss in patients with HIV wasting syndrome.

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

Details

• Lead Sponsor: Celgene Corporation
• Treatments: Thalidomide

Criteria

Inclusion Criteria

Concurrent Medication:

Allowed:

• Primary prophylaxis for opportunistic infections (if AFB blood culture negative).

• Chronic suppressive therapy (maintenance) for opportunistic infections OTHER THAN Mycobacterium avium Complex (MAC).

Patients must have:

• Documented HIV infection.

• Wasting syndrome.

• Negative blood PCR for acid-fast bacteria (AFB) or a negative AFB blood culture within 48 days prior to study entry.

• No active opportunistic infection requiring systemic therapy within 6 weeks prior to study entry.

• Life expectancy of at least 6 weeks.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

• Chronic diarrhea (five or more unformed stools per day).

• Peripheral neuropathy of grade 2 or worse.

• Requirement for tube feeding or intravenous feeding.

• Any disorder associated with moderate to severe edema (e.g., cirrhosis, nephrosis, congestive heart failure).

• Inability to ingest at least a maintenance diet based on present weight.

• Any condition that precludes study participation.

• Not under the care of a primary physician.

Concurrent Medication:

Excluded:

• Chronic suppressive therapy (maintenance) or secondary prophylaxis for Mycobacterium avium Complex (MAC) (suppressive therapy for other opportunistic infections is allowed).

Concurrent Treatment:

Excluded:

• Radiotherapy.

Patients with the following prior conditions are excluded:

• Any neoplasms other than non-medicated (i.e., not receiving systemic or intralesional chemotherapy) Kaposi's sarcoma within 1 month prior to study entry.

• Prior intolerance to thalidomide.

Prior Medication:

Excluded:

• ddC within 1 month prior to study entry.

• Acute systemic therapy for opportunistic infections within 6 weeks prior to study entry.

• Agents that are anabolic, catabolic, or immunomodulatory (including interferons, megestrol, dronabinol, oxandrolone, growth hormone, systemic corticosteroids, and pentoxifylline) within 30 days prior to study entry.

Prior Treatment:

Excluded:

• Radiotherapy within 6 weeks prior to study entry.

Required ONLY IF patient is on antiretroviral therapy:

• Stable regimen of AZT or ddI for at least 1 month prior to study entry. Active drug abuse within 3 months prior to study entry.