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

Patients are randomized to receive either thalidomide at 1 of 2 doses or placebo for 8 weeks. Patients who respond may continue in double-blinded treatment for an additional 4 weeks; nonresponding patients may receive thalidomide for up to 4 weeks. Per amendment, patients may receive thalidomide for more than 12 weeks on a compassionate basis.

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.