Effectiveness of Modafinil for Treating Fatigue in Adults With HIV/AIDS - Full Text View

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 IV

MedlinePlus related topics:

AIDS Depression

ChemIDplus related topics:

Modafinil

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Official Title:	Modafinil Treatment for Fatigue in HIV+ Patients

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 ]

Estimated Enrollment:	120
Study Start Date:	January 2005
Estimated Study Completion Date:	February 2010
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1. Modafinil, responsive: Experimental 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
2. Placebo, Modafinil: Placebo Comparator 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
3. Modafinil, nonresponsive: Experimental 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

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.

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

Publications:

Rabkin JG, McElhiney MC, Rabkin R, Ferrando SJ. Modafinil treatment for fatigue in HIV+ patients: a pilot study. J Clin Psychiatry. 2004 Dec;65(12):1688-95.

Responsible Party:	New York State Psychiatric Institute ( Judith Rabkin, PhD )
Study ID Numbers:	R01 MH72383, DAHBR 9A-ASNM
First Received:	July 6, 2005
Last Updated:	August 11, 2008
ClinicalTrials.gov Identifier:	NCT00118378
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):

HIV

AIDS

Modafinil

Depression

Study placed in the following topic categories:

Virus Diseases

Signs and Symptoms

Sexually Transmitted Diseases, Viral

Depression

Fatigue

HIV Infections

Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome

Depressive Disorder

Retroviridae Infections

Modafinil

Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

RNA Virus Infections

Slow Virus Diseases

Immune System Diseases

Therapeutic Uses

Physiological Effects of Drugs

Lentivirus Infections

Central Nervous System Stimulants

Infection

Protective Agents

Neuroprotective Agents

Central Nervous System Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on September 05, 2008

Sponsored by:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00118378