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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.
 
ClinicalTrials.gov Identifier: NCT00118378
Recruitment Status : Completed
First Posted : July 11, 2005
Results First Posted : June 9, 2014
Last Update Posted : May 10, 2017
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
New York State Psychiatric Institute

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
HIV Infections Fatigue Drug: Modafinil Drug: Placebo Phase 4

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 115 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Modafinil Treatment for Fatigue in HIV+ Patients
Study Start Date : December 2004
Actual Primary Completion Date : June 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fatigue HIV/AIDS
Drug Information available for: Modafinil

Arms and Interventions
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Arm Intervention/treatment
Experimental: Modafinil
Participants will take modafinil for 4 weeks.
 Drug: Modafinil
50 mg per day, increasing to 200 mg per day as clinically indicated
Other Name: Provigil
Placebo Comparator: Placebo
Participants will take placebo for 4 weeks.
 Drug: Placebo
50 mg per day, increasing to 200 mg per day as clinically indicated
Other Name: sugar pill


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00118378


Locations
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United States, New York
New York State Psychiatric Institute
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Judith G. Rabkin, PhD, MPH Columbia University
More Information
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Additional Information:

Publications of Results:

Other Publications:

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Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00118378    
Other Study ID Numbers: #4839
R01MH072383-01 ( U.S. NIH Grant/Contract )
DAHBR 9A-ASNM
First Posted: July 11, 2005    Key Record Dates
Results First Posted: June 9, 2014
Last Update Posted: May 10, 2017
Last Verified: March 2017
Keywords provided by New York State Psychiatric Institute:
HIV
AIDS
Modafinil
Depression
Additional relevant MeSH terms:
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Fatigue
Modafinil
Central Nervous System Stimulants
Physiological Effects of Drugs
 Wakefulness-Promoting Agents
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action