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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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HIV Infections, HIV Wasting Syndrome

Intervention / Treatment
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* Drug: Thalidomide


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Thalidomide|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acquired Immunodeficiency Syndrome, Cachexia, Thalidomide