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

Sponsored by:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00737204

Purpose

This study will determine whether armodafinil (Nuvigil), an FDA approved medication, is effective in reducing fatigue in adults with HIV/AIDS.

Condition	Intervention	Phase
HIV Infections Fatigue	Drug: Armodafinil	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Parallel Assignment, Efficacy Study
Official Title:	Armodafinil Treatment for Fatigue in HIV+ Patients

Resource links provided by NLM:

MedlinePlus related topics: AIDS Depression

Drug Information available for: Armodafinil

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 Weeks 4 and 12 ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	June 2008
Estimated Study Completion Date:	February 2010
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1. Armodafinil, responsive: Experimental Participants will receive armodafinil for 4 weeks. If responsive, participants will be offered 12 additional weeks of armodafinil.	Drug: Armodafinil Participants will receive 50 mg of armodafinil per day, increasing to 200 mg per day as clinically indicated.
2. Placebo, Armodafinil: Placebo Comparator Participants will receive a placebo pill for 4 weeks, then a 16-week course of armodafinil.	Drug: Armodafinil Participants will receive 50 mg of armodafinil per day, increasing to 200 mg per day as clinically indicated.
3. Armodafinil, nonresponsive: Active Comparator Participants will receive armodafinil for 4 weeks. If nonresponsive, participants will be offered 12 weeks of an alternative treatment.	Drug: Armodafinil Participants will receive 50 mg of armodafinil 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. 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.

This study will last 18 weeks. Participants will be randomly assigned to receive either armodafinil or a placebo daily for 4 weeks. Participants who show improvements in symptoms will be offered armodafinil for an additional 12 weeks. Participants who did not receive armodafinil will be offered armodafinil for 16 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.

For information on a related study, please follow this URL:

http://clinicaltrials.gov/show/NCT00118378

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: NCT00737204

Contacts

Contact: Judith G. Rabkin, PhD, MPH

212-543-5762

jgr1@columbia.edu

Locations

United States, New York
New York State Psychiatric Institute	Recruiting
New York, New York, United States, 10032
Contact: Judith G. Rabkin, PhD, MPH 212-543-5762 jgr1@columbia.edu
Principal Investigator: Judith G. Rabkin, PhD, MPH

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 MH072383-02, DAHBR 9A-ASNK
Study First Received:	August 14, 2008
Last Updated:	March 16, 2009
ClinicalTrials.gov Identifier:	NCT00737204 History of Changes
Health Authority:	United States: Federal Government

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

HIV
AIDS
Armodafinil
Depression

Study placed in the following topic categories:

Sexually Transmitted Diseases, Viral
Fatigue
Depression
Acquired Immunodeficiency Syndrome
Central Nervous System Stimulants
Depressive Disorder
Neuroprotective Agents

Immunologic Deficiency Syndromes
Modafinil
Virus Diseases
Signs and Symptoms
HIV Infections
Sexually Transmitted Diseases
Retroviridae Infections

Additional relevant MeSH terms:

RNA Virus Infections
Sexually Transmitted Diseases, Viral
Fatigue
Slow Virus Diseases
Immune System Diseases
Physiological Effects of Drugs
Acquired Immunodeficiency Syndrome
Central Nervous System Stimulants
Infection
Protective Agents
Neuroprotective Agents

Pharmacologic Actions
Modafinil
Immunologic Deficiency Syndromes
Virus Diseases
Signs and Symptoms
HIV Infections
Therapeutic Uses
Sexually Transmitted Diseases
Lentivirus Infections
Central Nervous System Agents
Retroviridae Infections

ClinicalTrials.gov processed this record on July 02, 2009