Text Size

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
History of Changes
  Purpose

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 Intervention Phase
HIV Infections
Fatigue
 Drug: Modafinil
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Modafinil Treatment for Fatigue in HIV+ Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 115
Study Start Date: January 2005
Study Completion Date: November 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1. Modafinil, responsive
Participants will take modafinil for 4 weeks. If responsive, participants will be offered 8 additional weeks of modafinil.
 Drug: Modafinil
50 mg per day, increasing to 200 mg per day as clinically indicated
Other Name: Provigil
Placebo Comparator: 2. Placebo, Modafinil
Participants will take placebo for 4 weeks, then a 12-week course of modafinil.
 Drug: Modafinil
50 mg per day, increasing to 200 mg per day as clinically indicated
Other Name: Provigil
Experimental: 3. Modafinil, nonresponsive
Participants will take modafinil for 4 weeks. If nonresponsive, they will be offered an alternative treatment.
 Drug: Modafinil
50 mg per day, increasing to 200 mg per day as clinically indicated
Other Name: Provigil

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.

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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00118378

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

Additional Information:
Click here for a related study currently recruiting participants.  This link exits the ClinicalTrials.gov site

Publications:
Rabkin JG, McElhiney M, Rabkin R, McGrath P. Modafinil treatment for fatigue in HIV/AIDS: A randomized placebo-ctontrolled study. J. Clinical Psychiatry 2010; 71:707-715

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Judith Rabkin, PhD, New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00118378     History of Changes
Other Study ID Numbers: R01 MH072383-01, DAHBR 9A-ASNM
Study First Received: July 6, 2005
Last Updated: November 23, 2010
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
HIV
AIDS
Modafinil
Depression

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Fatigue
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
 Slow Virus Diseases
Signs and Symptoms
Modafinil
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Neuroprotective Agents
Protective Agents

ClinicalTrials.gov processed this record on May 16, 2013