Effectiveness of Modafinil for Treating Fatigue in Adults With HIV/AIDS

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00118378
Recruitment Status : Completed
First Posted : July 11, 2005
Results First Posted : June 9, 2014
Last Update Posted : May 10, 2017
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
New York State Psychiatric Institute

July 6, 2005
July 11, 2005
January 3, 2012
June 9, 2014
May 10, 2017
December 2004
June 2010   (Final data collection date for primary outcome measure)
  • Fatigue Severity Scale (FSS) [ Time Frame: Measured at baseline and Week 4 ]
    The FSS is a 9-item self-report scale that measures the impact of fatigue on everyday functioning. Each item is rated on a scale of 1 to 7. Total scores range from 9 to 63, with a higher value indicating greater impairment due to fatigue.
  • Role Function Scale Outcome [ Time Frame: Measured at baseline and Week 4 ]
    The Role Function Scale includes 10 items drawn from the Short Form 36-item Health Survey (SF-36) and other SF versions. It is intended to assess the extent to which fatigue has a behavioral impact on daily activities. Scores of frequency in the past week, on a 5-point scale, are summed with higher scores signifying greater role impairment. Scores range from 10 to 50.
  • Fatigue severity scale outcome
  • Role Function Scale Outcome
Complete list of historical versions of study NCT00118378 on Archive Site
  • CD4 Cell Count [ Time Frame: Measured at baseline and Week 4 ]
    CD4 cell count is a laboratory marker providing an indication of immune functioning. Blood was drawn for this measure at baseline and week 4. The reference range for CD4 cell count is 490-1740, and a clinically significant change is defined as a change of >= 100 cells. A higher number is associated with better immune functioning.
  • HIV RNA Viral Load [ Time Frame: Measured at baseline and Week 4 ]
    HIV RNA viral load assay is a laboratory measure indicating viral activity. Because of the large range of possible values (50-100,000 copies), this measure is presented in log10. We entered the log10 value of 1.69 when the laboratory result stated "under 50 copies," which was the assay's lowest limit of detectability during the study.
  • CD4 Cell Count
  • HIV viral load
  • Hamilton Rating Scale for Depression
  • Beck Depression Inventory II
  • Cognitive function
Not Provided
Not Provided
Effectiveness of Modafinil for Treating Fatigue in Adults With HIV/AIDS
Modafinil Treatment for Fatigue in HIV+ Patients
This study will determine whether modafinil (Provigil®), a medication approved for the treatment of narcolepsy, 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. This study will determine if modafinil can reduce fatigue in HIV/AIDS patients.

This study will last 12 weeks. Participants will be randomly assigned to receive either modafinil or placebo daily for 4 weeks. Participants who show an improvement in symptoms will receive modafinil for an additional 8 weeks. Participants who do not respond to modafinil will have the opportunity to receive other drug treatments. 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.

Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
  • HIV Infections
  • Fatigue
  • Drug: Modafinil
    50 mg per day, increasing to 200 mg per day as clinically indicated
    Other Name: Provigil
  • Drug: Placebo
    50 mg per day, increasing to 200 mg per day as clinically indicated
    Other Name: sugar pill
  • Experimental: Modafinil
    Participants will take modafinil for 4 weeks.
    Intervention: Drug: Modafinil
  • Placebo Comparator: Placebo
    Participants will take placebo for 4 weeks.
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
November 2010
June 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Ages 18-75
  2. HIV+
  3. Clinically significant fatigue (score of 4.5+ on Fatigue Severity Scale, plus impairment on 1+ categories of Role Function Scale)
  4. Fatigue duration for 3+ months
  5. English-speaking
  6. Able to give informed consent
  7. Fecund women uses barrier method of contraception

Exclusion Criteria:

  1. Primary care doctor does not approve of study participation
  2. Unstable medical condition (e.g. liver failure;cirrhosis, new onset opportunistic infection [O.I.] in past month)
  3. Untreated hypogonadism, except for men for whom testosterone replacement is medically contraindicated (serum testosterone below the reference range)
  4. Untreated hypothyroidism (thyroid stimulating hormone [TSH] over 5 IUI/mL)
  5. Untreated and uncontrolled hypertension
  6. Clinically significant anemia (hematocrit <30%)
  7. Started testosterone or nandrolone in past 6 weeks
  8. Started or changed an antiretroviral regimen in past 4 weeks if fatigue predated the change; otherwise, started or changed regimen in past 2 months
  9. Untreated or under-treated major depressive disorder
  10. Started antidepressant medication within past 6 weeks
  11. Substance abuse/dependence (past 4 months)
  12. Regular and frequent cannabis use (> twice/week regularly)
  13. Currently clinically significant suicidal ideation or Hamilton Depression Rating Scale (HAM-D) >24
  14. History or current psychosis or bipolar disorder
  15. Pregnant or breastfeeding
  16. Significant untreated insomnia (score >3 on HAM-D insomnia items)
  17. Currently taking psychostimulant medication or past nonresponse to modafinil
  18. Has no alternative viable antiretroviral regimen after the current one
  19. Left ventricular hypertrophy; mitral valve prolapse
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
R01MH072383-01 ( U.S. NIH Grant/Contract )
Not Provided
Not Provided
New York State Psychiatric Institute
New York State Psychiatric Institute
National Institute of Mental Health (NIMH)
Principal Investigator: Judith G. Rabkin, PhD, MPH Columbia University
New York State Psychiatric Institute
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP