Compassionate Use Study of Two Dose Levels of Thalidomide in Adults With HIV Wasting Syndrome

Celgene Corporation

Overview

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Masking

NONE

Conditions

HIV Infections HIV Wasting Syndrome

Interventions

ThalidomideDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria Concurrent Medication: Allowed: * Antiretroviral therapy. * Prophylaxis or treatment for opportunistic infection. Patients must have: HIV-associated wasting. Prior Medication: Allowed: * Prior enrollment on Celgene's placebo-controlled thalidomide study, provided patient meets specified criteria for not continuing on that study.

Locations (1)

Celgene Corp

Warren Township, New Jersey, United States

Data from ClinicalTrials.gov

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