HIV Infections Clinical Trial
Official title:
Armodafinil Treatment for Fatigue in HIV+ Patients
This study will determine whether armodafinil (Nuvigil), an FDA approved medication, 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. A related
study tested whether modafinil, of which armodafinil is an r-isomer, could reduce fatigue in
HIV/AIDS patients. Armodafinil, believed to have a longer duration and greater effect than
modafinil, will be tested on the same criteria.
Participants will be randomly assigned to receive either armodafinil or a placebo daily for
4 weeks. Participants randomized to active medication and who show improvements in symptoms
will be offered armodafinil for an additional 12 weeks. For them, the study duration is 16
weeks. Participants who did not receive armodafinil will be offered armodafinil for 16
weeks. For these participants, the study duration is 20 weeks. Participants who did not
benefit from armodafinil will receive alternate treatment options. 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. After completion of 16 weeks, participants responding to armodafinil will be
transitioned to the publicly available modafinil over the course of 2 weeks.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment
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