Treatment of HIV-related fatigue with armodafinil: a placebo-controlled randomized trial.

ABSTRACT:

Objective

To evaluate the efficacy and safety of armodafinil in the treatment of fatigue in HIV+ patients, and to assess its effect on depressive symptoms and behavior once fatigue remitted.

Method

HIV+ patients with clinically significant fatigue were treated in a placebo-controlled randomized double-blind trial for 4 weeks. Armodafinil responders and placebo non-responders or relapsers were treated openly for a total of 16 weeks with armodafinil. The primary outcome measure for fatigue and depression was the Clinical Global Impressions-Improvement Scale, supplemented by the Fatigue Severity Scale, the Hamilton Depression Rating Scale, and the Beck Depression Inventory. Safety was assessed with assays of CD4 cell count and HIV RNA viral load and the SAFTEE side effects rati

SUBMITTER: Rabkin JG 

PROVIDER: S-EPMC3142348 | biostudies-literature | 2011 Jul-Aug

REPOSITORIES: biostudies-literature