Effectiveness of Armodafinil 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: NCT00737204
Recruitment Status : Completed
First Posted : August 18, 2008
Results First Posted : June 12, 2014
Last Update Posted : June 12, 2014
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
New York State Psychiatric Institute

August 14, 2008
August 18, 2008
March 13, 2013
June 12, 2014
June 12, 2014
June 2008
April 2010   (Final data collection date for primary outcome measure)
  • Fatigue Severity Scale(FSS) Outcome [ Time Frame: Measured at baseline and Weeks 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 9-63, with a higher score indicating greater impairment due to fatigue.
  • Role Function Scale [ Time Frame: Measured at Baseline and Week 4 ]
    The Role Function Scale includes 10 items drawn from the Short Form 36-item 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 10-50.
  • Fatigue severity scale outcome [ Time Frame: Measured at baseline and Weeks 4 and 12 ]
  • Role function scale outcome [ Time Frame: Measured at baseline and Weeks 4 and 12 ]
Complete list of historical versions of study NCT00737204 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 system functioning. Blood samples were 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 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 transformed to log10 values. 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 [ Time Frame: Measured at baseline and Weeks 4 and 12 ]
  • HIV Viral Load [ Time Frame: Measured at baseline and Weeks 4 and 12 ]
  • Hamilton rating scale for depression [ Time Frame: Measured at baseline and Weeks 4 and 12 ]
  • Beck Depression Inventory II [ Time Frame: Measured at baseline and Weeks 4 and 12 ]
  • Cognitive function [ Time Frame: Measured at baseline and Weeks 4 and 12 ]
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Effectiveness of Armodafinil for Treating Fatigue in Adults With HIV/AIDS
Armodafinil Treatment for Fatigue in HIV+ Patients
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.

Participants will be randomly assigned to receive either armodafinil or a placebo daily for 4 weeks. Participants randomized to active medication and who show improvements in symptoms will be offered armodafinil for an additional 12 weeks. For them, the study duration is 16 weeks. Participants who did not receive armodafinil will be offered armodafinil for 16 weeks. For these participants, the study duration is 20 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.

Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
  • HIV Infections
  • Fatigue
  • Drug: Armodafinil
    Participants will receive 50 mg of armodafinil per day, increasing to 250 mg per day as clinically indicated.
    Other Name: Nuvigil
  • Drug: Placebo
    Participants will receive placebo pills matched to the active armodafinil and according to the same dosing strategy
    Other Name: Sugar pill
  • Experimental: Armodafinil
    Participants will take armodafinil for 4 weeks. The dose will be titrated up from 50mg to 250mg per day as clinically indicated, using 50mg tablets. If responsive, participants will be offered 12 additional weeks of armodafinil.
    Intervention: Drug: Armodafinil
  • Placebo Comparator: Placebo
    Participants will receive placebo pills for 4 weeks. Placebo tablets that match the 50mg active medication tablets will given following the same dosing strategy as Arm 1. The dose will be titrated from 1 placebo tablet daily to 5 tablets daily as clinically indicated. Non-responders to placebo will then be offered 16 weeks of active medication.
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
September 2010
April 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 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 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 Scale (HAM-D) score >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, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
R01MH072383-02 ( U.S. NIH Grant/Contract )
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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 2013

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