drugset / Trial / NCT00737204
Effectiveness of Armodafinil for Treating Fatigue in Adults With HIV/AIDS
Phase 4
Completed
70 enrolled
New York State Psychiatric Institute
National Institute of Mental Health (NIMH) · collab
RandomizedParallel-groupTriple-blindTreatment
Summary
This study will determine whether armodafinil (Nuvigil), an FDA approved medication, is effective in reducing fatigue in adults with HIV/AIDS.
Timeline
- Start
- 2008-06
- Primary completion
- 2010-04
- Completion
- 2010-09
Outcome
Met primary endpoint
registry analysis (superiority or other test); Armodafinil vs Placebo; p <0.001; ANCOVA NCT00737204 ↗
registry analysis (superiority or other test); Armodafinil vs Placebo; p = .01; ANCOVA NCT00737204 ↗
Publications
- Background Rabkin JG, McElhiney MC, Rabkin R, Ferrando SJ. Modafinil treatment for fatigue in HIV+ patients: a pilot study. J Clin Psychiatry. 2004 Dec;65(12):1688-95. doi: 10.4088/jcp.v65n1215.
- Results Rabkin JG, McElhiney MC, Rabkin R. Treatment of HIV-related fatigue with armodafinil: a placebo-controlled randomized trial. Psychosomatics. 2011 Jul-Aug;52(4):328-36. doi: 10.1016/j.psym.2011.02.005.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Armodafinil | Small molecule | 250 mg | — |