Effectiveness of Armodafinil for Treating 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.

This study will last 18 weeks. Participants will be randomly assigned to receive either
armodafinil or a placebo daily for 4 weeks. Participants who show improvements in symptoms
will be offered armodafinil for an additional 12 weeks. Participants who did not receive
armodafinil will be offered armodafinil for 16 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.

For information on a related study, please follow this URL:

http://clinicaltrials.gov/show/NCT00118378