HIV Infections, HIV Wasting Syndrome
Conditions
Keywords
Acquired Immunodeficiency Syndrome, Cachexia, Thalidomide
Brief 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.
Detailed description
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.
Interventions
DRUGThalidomide
Sponsors
Celgene Corporation
Study design
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Countries
United States
Outcome results
None listed