Modafinil treatment for fatigue in HIV+ patients: a pilot study.
BACKGROUND
Fatigue is widespread among human immunodeficiency virus-positive (HIV+) patients, yet few studies have assessed effective treatments. The authors conducted a pilot study to evaluate the efficacy of modafinil for fatigue in this clinical population.


METHODS
Response was evaluated after a 4-week open-label trial. Data were collected from February 2003 through January 2004. Responders were offered 8 additional weeks of modafinil. Inclusion criteria included written approval from the primary care physician, clinically significant fatigue, current use of anti-retroviral medications, and the absence of treatable medical conditions known to cause fatigue. Exclusion criteria included untreated major depression and current substance abuse. Major outcome measures were the Fatigue Severity Scale, Chalder Fatigue Scale, Hamilton Rating Scale for Depression, Beck Depression Inventory, and neuropsychological tests assessing verbal memory, speed of processing, and executive function. Immunologic and virologic measures were performed at baseline and week 4 to assess safety of treatment.


RESULTS
All 30 patients who enrolled completed 4 weeks of treatment; 24 (80%) were rated as responders. Responders showed statistically significant improvement on all measures of fatigue, depressive symptoms, and executive function, while nonresponders did not. Mean values of CD4 cell count and HIV RNA viral load did not change. The most common side effect was headache, followed by irritability and feeling "hyper."


CONCLUSIONS
This pilot study shows encouraging results for modafinil in alleviation of fatigue in HIV+ patients. In addition, depressive symptoms were substantially reduced. Improvements on measures of verbal memory and executive function were significant, but in the absence of a placebo control, the magnitude of effect due to practice cannot be determined.
Rabkin
Judith G
JG
New York State Psychiatric Institute, New York, NY 10032, USA. jgr1@Columbia.edu
McElhiney
Martin C
MC
Rabkin
Richard
R
Ferrando
Stephen J
SJ
D000328:Adult; D000368:Aged; D044966:Anti-Retroviral Agents / Q000627:therapeutic use; D001559:Benzhydryl Compounds / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D018791:CD4 Lymphocyte Count / Q000706:statistics & numerical data; D000697:Central Nervous System Stimulants / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D015897:Comorbidity; D003866:Depressive Disorder / Q000175:diagnosis / Q000188:drug therapy / Q000453:epidemiology; D004359:Drug Therapy, Combination; D005221:Fatigue / Q000188:drug therapy* / Q000209:etiology; D005260:Female; D006678:HIV / Q000187:drug effects; D015658:HIV Infections / Q000150:complications* / Q000175:diagnosis / Q000188:drug therapy; D006679:HIV Seropositivity / Q000150:complications / Q000188:drug therapy / Q000453:epidemiology; D006801:Humans; D008297:Male; D008875:Middle Aged; D000077408:Modafinil; D009483:Neuropsychological Tests; D010555:Personality Inventory; D010865:Pilot Projects; D011569:Psychiatric Status Rating Scales; D012367:RNA, Viral / Q000097:blood / Q000187:drug effects; D016896:Treatment Outcome; D019562:Viral Load / Q000706:statistics & numerical data
D044966:Anti-Retroviral Agents; D001559:Benzhydryl Compounds; D000697:Central Nervous System Stimulants; D012367:RNA, Viral; D000077408:Modafinil