Fatigue continues to be a major problem for many people with HIV/AIDS, even when their health is otherwise stable or restored by antiretroviral medication. Fatigue in HIV is associated with disability and diminished life satisfaction, and is a significant barrier for those who consider returning to work. While earlier in the epidemic, fatigue was attributed to the virus and concomitant opportunistic infections, more recently it seems that the otherwise life-extending antiretrovirals also play a role. Previous research by our group and others has demonstrated that fatigue in patients with HIV/AIDS is responsive to psychostimulants such as dextroamphetamine and methylphenidate. However, access to these drugs is limited by physician reluctance to prescribe them, dose escalation is often necessary, and for patients with substance abuse histories they are largely contraindicated. Consequently, there remains a significant unmet need for an effective treatment for HIV-associated fatigue. We propose to conduct a 4-week placebo controlled double blind trial of modafinil for HIV+ patients with clinically significant fatigue, followed by an 8-week maintenance phase for modafinil responders. Modafinil is approved for the treatment of narcolepsy, but its use has been extended to treat fatigue and excessive daytime sleepiness in other patient groups with neurological disease or depression, and findings have been positive. We plan to enter 120 patients with the expectation of having at least 100 study completers. The major aims concern modafinil efficacy for fatigue compared to placebo, safety in terms of effects on immunologic/virologic measures, and impact on depressive symptoms when present at baseline.

Agency
National Institute of Health (NIH)
Institute
National Institute of Mental Health (NIMH)
Type
Research Project (R01)
Project #
5R01MH072383-03
Application #
7188104
Study Section
Behavioral and Social Consequences of HIV/AIDS Study Section (BSCH)
Program Officer
Joseph, Jeymohan
Project Start
2005-03-03
Project End
2009-02-28
Budget Start
2007-03-09
Budget End
2008-02-29
Support Year
3
Fiscal Year
2007
Total Cost
$354,880
Indirect Cost
Name
New York State Psychiatric Institute
Department
Type
DUNS #
167204994
City
New York
State
NY
Country
United States
Zip Code
10032
Doshi, Shreya; Keilp, John G; Strobino, Barbara et al. (2018) Depressive Symptoms and Suicidal Ideation Among Symptomatic Patients With a History of Lyme Disease vs Two Comparison Groups. Psychosomatics 59:481-489
McElhiney, Martin; Rabkin, Judith; Van Gorp, Wilfred et al. (2013) Effect of armodafinil on cognition in patients with HIV/AIDS and fatigue. J Clin Exp Neuropsychol 35:718-27
Rabkin, J G; McElhiney, M C; Rabkin, R (2011) Modafinil and armodafinil treatment for fatigue for HIV-positive patients with and without chronic hepatitis C. Int J STD AIDS 22:95-101
Rabkin, Judith G; McElhiney, Martin C; Rabkin, Richard (2011) Treatment of HIV-related fatigue with armodafinil: a placebo-controlled randomized trial. Psychosomatics 52:328-36
Rabkin, Judith G; McElhiney, Martin C; Rabkin, Richard et al. (2010) Modafinil treatment for fatigue in HIV/AIDS: a randomized placebo-controlled study. J Clin Psychiatry 71:707-15
McElhiney, Martin; Rabkin, Judith; Van Gorp, Wilfred et al. (2010) Modafinil effects on cognitive function in HIV+ patients treated for fatigue: a placebo controlled study. J Clin Exp Neuropsychol 32:474-80