Modafinil Treatment for Fatigue in HIV+ Patients

Summary

Principal Investigator: J G Rabkin
Abstract: 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.
Funding Period: 2005-03-03 - 2009-08-28
more information: NIH RePORT

Top Publications

  1. pmc Modafinil effects on cognitive function in HIV+ patients treated for fatigue: a placebo controlled study
    Martin McElhiney
    Department of Psychiatry, College of Physicians and Surgeons, Columbia University, New York, NY, USA
    J Clin Exp Neuropsychol 32:474-80. 2010
  2. pmc Modafinil treatment for fatigue in HIV/AIDS: a randomized placebo-controlled study
    Judith G Rabkin
    Department of Psychiatry, College of Physicians and Surgeons, Columbia University, and New York State Psychiatric Institute, New York, NY 10032, USA
    J Clin Psychiatry 71:707-15. 2010
  3. ncbi Modafinil and armodafinil treatment for fatigue for HIV-positive patients with and without chronic hepatitis C
    J G Rabkin
    New York State Psychiatric Institute and Department of Psychiatry, College of Physicians and Surgeons, Columbia University, New York, NY 10032, USA
    Int J STD AIDS 22:95-101. 2011
  4. pmc Treatment of HIV-related fatigue with armodafinil: a placebo-controlled randomized trial
    Judith G Rabkin
    New York State Psychiatric Institute and Department of Psychiatry, College of Physicians and Surgeons, Columbia University, 1051 Riverside Drive, New York, NY 10032, USA
    Psychosomatics 52:328-36. 2011
  5. pmc Effect of armodafinil on cognition in patients with HIV/AIDS and fatigue
    Martin McElhiney
    a Department of Psychiatry, College of Physicians and Surgeons, Columbia University, New York, NY, USA
    J Clin Exp Neuropsychol 35:718-27. 2013

Detail Information

Publications5

  1. pmc Modafinil effects on cognitive function in HIV+ patients treated for fatigue: a placebo controlled study
    Martin McElhiney
    Department of Psychiatry, College of Physicians and Surgeons, Columbia University, New York, NY, USA
    J Clin Exp Neuropsychol 32:474-80. 2010
    ..In addition, cognitive performance, as measured by a global change score, improved more in the modafinil than in the placebo group although the effect was not specific to any cognitive domain...
  2. pmc Modafinil treatment for fatigue in HIV/AIDS: a randomized placebo-controlled study
    Judith G Rabkin
    Department of Psychiatry, College of Physicians and Surgeons, Columbia University, and New York State Psychiatric Institute, New York, NY 10032, USA
    J Clin Psychiatry 71:707-15. 2010
    ..To evaluate the efficacy and safety of modafinil in the treatment of fatigue in patients with human immunodeficiency virus/acquired immune deficiency syndrome (HIV/AIDS) and to assess effect on depressive symptoms...
  3. ncbi Modafinil and armodafinil treatment for fatigue for HIV-positive patients with and without chronic hepatitis C
    J G Rabkin
    New York State Psychiatric Institute and Department of Psychiatry, College of Physicians and Surgeons, Columbia University, New York, NY 10032, USA
    Int J STD AIDS 22:95-101. 2011
    ..Further investigation in a focused trial is warranted...
  4. pmc Treatment of HIV-related fatigue with armodafinil: a placebo-controlled randomized trial
    Judith G Rabkin
    New York State Psychiatric Institute and Department of Psychiatry, College of Physicians and Surgeons, Columbia University, 1051 Riverside Drive, New York, NY 10032, USA
    Psychosomatics 52:328-36. 2011
    ..To evaluate the efficacy and safety of armodafinil in the treatment of fatigue in HIV+ patients, and to assess its effect on depressive symptoms and behavior once fatigue remitted...
  5. pmc Effect of armodafinil on cognition in patients with HIV/AIDS and fatigue
    Martin McElhiney
    a Department of Psychiatry, College of Physicians and Surgeons, Columbia University, New York, NY, USA
    J Clin Exp Neuropsychol 35:718-27. 2013
    ....