HIV Infections Clinical Trial
Official title:
Modafinil Treatment for Fatigue in HIV+ Patients
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.
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
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