NCT00118378

Effectiveness of Modafinil for Treating Fatigue in Adults With HIV/AIDS

Modafinil Treatment for Fatigue in HIV+ Patients

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 115 (actual)
• Sponsor: New York State Psychiatric Institute · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study will determine whether modafinil (Provigil®), a medication approved for the treatment of narcolepsy, is effective in reducing fatigue in adults with HIV/AIDS.

Detailed description

Fatigue is a common problem for many people with HIV/AIDS, interfering with daily activities and serving as a significant barrier to working among those whose health is otherwise stable or restored by antiretroviral (ARV) medication. Fatigue in HIV is associated with disability and diminished quality of life. It may be caused by ARVs or by the virus itself. This study will determine if modafinil can reduce fatigue in HIV/AIDS patients. This study will last 12 weeks. Participants will be randomly assigned to receive either modafinil or placebo daily for 4 weeks. Participants who show an improvement in symptoms will receive modafinil for an additional 8 weeks. Participants who do not respond to modafinil will have the opportunity to receive other drug treatments. All participants will have weekly study visits for the first 4 weeks of the study and biweekly visits for the remainder of the study. At each visit, participants will complete various tasks to determine cognitive function and self-report scales will be used to determine symptoms of depression and fatigue.

Conditions

• HIV Infections
• Fatigue

Interventions

Type	Name	Description
DRUG	Modafinil	50 mg per day, increasing to 200 mg per day as clinically indicated
DRUG	Placebo	50 mg per day, increasing to 200 mg per day as clinically indicated

Timeline

• Start date: 2004-12-01
• Primary completion: 2010-06-01
• Completion: 2010-11-01
• First posted: 2005-07-11
• Last updated: 2017-05-10
• Results posted: 2014-06-09

Locations

1 site across 1 country: United States