• Fatigue severity scale outcome [ Time Frame: Measured at baseline and Weeks 4 and 12 ] [ Designated as safety issue: No ]
• Role function scale outcome [ Time Frame: Measured at baseline and Weeks 4 and 12 ] [ Designated as safety issue: No ]

• CD4 cell count [ Time Frame: Measured at baseline and Weeks 4 and 12 ] [ Designated as safety issue: Yes ]
• HIV viral load [ Time Frame: Measured at baseline and Weeks 4 and 12 ] [ Designated as safety issue: Yes ]
• Hamilton rating scale for depression [ Time Frame: Measured at baseline and Weeks 4 and 12 ] [ Designated as safety issue: No ]
• Beck Depression Inventory II [ Time Frame: Measured at baseline and Weeks 4 and 12 ] [ Designated as safety issue: No ]
• Cognitive function [ Time Frame: Measured at baseline and Weeks 4 and 12 ] [ Designated as safety issue: No ]

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.

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

• HIV Infections
• Fatigue

• Experimental: Participants will receive armodafinil for 4 weeks. If responsive, participants will be offered 12 additional weeks of armodafinil.
• Placebo Comparator: Participants will receive a placebo pill for 4 weeks, then a 16-week course of armodafinil.
• Active Comparator: Participants will receive armodafinil for 4 weeks. If nonresponsive, participants will be offered 12 weeks of an alternative treatment.

Inclusion Criteria:

• HIV infected
• Clinically significant fatigue for at least 3 months before study entry
• Able to speak English
• Willing to use acceptable methods of contraception

Exclusion Criteria:

• Insufficient production of thyroid hormones (hypothyroidism) or untreated malfunctioning of testes or ovaries (hypogonadism)
• Uncontrolled hypertension
• Clinically significant anemia
• Initiation of testosterone or nandrolone (a steroid) treatment within 6 weeks before study entry
• Began or changed an ARV regimen within 12 weeks before study entry
• Untreated major depression
• Initiation of antidepressant medication within 6 weeks before study entry
• Current substance abuse or dependence that may interfere with the study
• Regular cannabis use
• Previous or current nondrug-induced psychosis or bipolar disorder
• Current use of psychostimulant medication
• Previous nonresponse to an adequate trial of modafinil
• Any unstable medical condition
• Previously failed ARV regimens and currently on last viable ARV regimen
• Pregnancy or breastfeeding
• Primary care doctor does not approve of study participation