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

Completed · Phase 2

Conditions studied: HIV Infections, HIV Wasting Syndrome

In brief

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.

Key facts

Study ID

NCT00002127

Run by

Celgene Corporation

People needed

75

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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:

Where it is running

• Marin County Specialty Clinic — Greenbrae, California, United States
• AIDS Community Research Consortium — Redwood City, California, United States
• UCSD Med Ctr - Owen Clinic — San Diego, California, United States
• San Francisco Gen Hosp — San Francisco, California, United States
• Kaiser Permanente Med Ctr — San Francisco, California, United States
• Gottlieb Med Group — Sherman Oaks, California, United States
• George Washington Univ Med Ctr — Washington D.C., District of Columbia, United States
• Community Research Initiative of South Florida — Coral Gables, Florida, United States
• Kansas City AIDS Research Consortium — Kansas City, Missouri, United States
• Saint Michael's Med Ctr — Newark, New Jersey, United States
• Rockefeller Univ — New York, New York, United States
• Thomas Jefferson Med College — Philadelphia, Pennsylvania, United States
• Advanced Research Management — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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