Compassionate Use Study of Two Dose Levels of Thalidomide in Adults With HIV Wasting Syndrome
To allow patients with HIV-associated wasting to receive thalidomide treatment at 1 of 2 doses. To gain safety and efficacy data from a broader base of patients with HIV-associated wasting in order to support Celgene's pivotal placebo-controlled study.
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Compassionate Use Study of Two Dose Levels of Thalidomide in Adults With HIV Wasting Syndrome|
Patients are randomized to receive thalidomide at 1 of 2 doses for 12 weeks initially, with response assessed at weeks 2, 4, 8, and 12. Patients failing the low dose will be eligible to increase the dose to the higher dose. Treatment may continue indefinitely. After 12 weeks, patients continuing treatment are evaluated every 2 months for up to 6 additional months, then every 6 months thereafter.