Status and phase
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About
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.
Full 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.
Sex
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Volunteers
Inclusion and exclusion criteria
Inclusion Criteria
Concurrent Medication:
Allowed:
Patients must have:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
Concurrent Treatment:
Excluded:
Patients with the following prior conditions are excluded:
Prior Medication:
Excluded:
Prior Treatment:
Excluded:
Required ONLY IF patient is on antiretroviral therapy:
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Data sourced from clinicaltrials.gov
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