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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT00737204
First received: August 14, 2008
Last updated: June 11, 2014
Last verified: March 2013

August 14, 2008
June 11, 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Role function scale outcome [ Time Frame: Measured at baseline and Weeks 4 and 12 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00737204 on ClinicalTrials.gov Archive Site
  • CD4 Cell Count [ Time Frame: Measured at baseline and Week 4 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
  • HIV viral load [ Time Frame: Measured at baseline and Weeks 4 and 12 ] [ Designated as safety issue: Yes ]
  • Hamilton rating scale for depression [ Time Frame: Measured at baseline and Weeks 4 and 12 ] [ Designated as safety issue: No ]
  • Beck Depression Inventory II [ Time Frame: Measured at baseline and Weeks 4 and 12 ] [ Designated as safety issue: No ]
  • Cognitive function [ Time Frame: Measured at baseline and Weeks 4 and 12 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00737204
#4839/5892R, R01MH072383-02
Yes
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