Conditions: HIV Infections Fatigue
Keywords: HIV AIDS Modafinil Depression
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 115
Healthy volunteers: no

Brief 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.

Arms:
arm 1: Participants will take modafinil for 4 weeks. arm 2: Participants will take placebo for 4 weeks.

Interventions: intervention 1: Modafinil intervention 2: Placebo
Intervention descriptions: intervention 1: 50 mg per day, increasing to 200 mg per day as clinically indicated intervention 2: 50 mg per day, increasing to 200 mg per day as clinically indicated

Protocol document: