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

This study has been completed.
Sponsor:
Information provided by:
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00118378
First received: July 6, 2005
Last updated: November 23, 2010
Last verified: November 2010

July 6, 2005
November 23, 2010
January 2005
June 2010   (final data collection date for primary outcome measure)
  • 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 ]
  • Fatigue severity scale outcome
  • role function scale outcome
Complete list of historical versions of study NCT00118378 on ClinicalTrials.gov Archive Site
  • 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 Week 4 ] [ Designated as safety issue: No ]
  • 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.

For information on an identical study using a related drug, please follow this URL: http://clinicaltrials.gov/show/NCT00737204

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: Modafinil
50 mg per day, increasing to 200 mg per day as clinically indicated
Other Name: Provigil
  • Experimental: 1. Modafinil, responsive
    Participants will take modafinil for 4 weeks. If responsive, participants will be offered 8 additional weeks of modafinil.
    Intervention: Drug: Modafinil
  • Placebo Comparator: 2. Placebo, Modafinil
    Participants will take placebo for 4 weeks, then a 12-week course of modafinil.
    Intervention: Drug: Modafinil
  • Experimental: 3. Modafinil, nonresponsive
    Participants will take modafinil for 4 weeks. If nonresponsive, they will be offered an alternative treatment.
    Intervention: Drug: Modafinil

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
115
November 2010
June 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • HIV infected
  • Clinically significant fatigue for at least 3 months before study entry
  • Able to speak English
  • Willing to use acceptable methods of contraception

Exclusion Criteria:

  • Insufficient production of thyroid hormones (hypothyroidism) or untreated malfunctioning of testes or ovaries (hypogonadism)
  • Uncontrolled hypertension
  • Clinically significant anemia
  • Initiation of testosterone or nandrolone (a steroid) treatment within 6 weeks before study entry
  • Began or changed an ARV regimen within 12 weeks before study entry
  • Untreated major depression
  • Initiation of antidepressant medication within 6 weeks before study entry
  • Current substance abuse or dependence that may interfere with the study
  • Regular cannabis use
  • Previous or current nondrug-induced psychosis or bipolar disorder
  • Current use of psychostimulant medication
  • Previous nonresponse to an adequate trial of modafinil
  • Any unstable medical condition
  • Previously failed ARV regimens and currently on last viable ARV regimen
  • Pregnancy or breastfeeding
  • Primary care doctor does not approve of study participation
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00118378
R01 MH072383-01, DAHBR 9A-ASNM
Yes
Judith Rabkin, PhD, New York State Psychiatric Institute
National Institute of Mental Health (NIMH)
Not Provided
Principal Investigator: Judith G. Rabkin, PhD, MPH Columbia University
National Institute of Mental Health (NIMH)
November 2010

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