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.
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.
- Antiretroviral therapy.
- Prophylaxis or treatment for opportunistic infection.
Patients must have:
- Prior enrollment on Celgene's placebo-controlled thalidomide study, provided patient
meets specified criteria for not continuing on that study.