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

Sponsor:	New York State Psychiatric Institute
Collaborator:	National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):	New York State Psychiatric Institute
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:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Armodafinil Treatment for Fatigue in HIV+ Patients

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: Depression Fatigue HIV/AIDS

Drug Information available for: Armodafinil

U.S. FDA Resources

Further study details as provided by New York State Psychiatric Institute:

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 ]

Enrollment:	70
Study Start Date:	June 2008
Study Completion Date:	September 2010
Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1. Armodafinil, responsive 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 250 mg per day as clinically indicated. Other Name: Nuvigil
Placebo Comparator: 2. Placebo, Armodafinil 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 250 mg per day as clinically indicated. Other Name: Nuvigil
Active Comparator: 3. Armodafinil, nonresponsive 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 250 mg per day as clinically indicated. Other Name: Nuvigil

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 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Ages 18-75
HIV+
Clinically significant fatigue (score of 4.5+ on Fatigue Severity Scale, plus impairment on 1+ categories of Role Function Scale [MOS Scale])
Fatigue duration for 3+ months
English-speaking
Able to give informed consent
Fecund women uses barrier method of contraception

Exclusion Criteria:

Primary care doctor does not approve of study participation
Unstable medical condition (e.g. liver failure;cirrhosis, new onset O.I. in past month)
Untreated hypogonadism, except for men for whom testosterone replacement is medically contraindicated (serum testosterone below the reference range)
Untreated hypothyroidism (TSH over 5 IUI/mL)
Untreated and uncontrolled hypertension
Clinically significant anemia (hematocrit <30%)
Started testosterone or nandrolone in past 6 weeks
Started or changed an antiretroviral regimen in past 4 weeks if fatigue predated the change; otherwise, started or changed regimen in past 2 months
Untreated or under-treated major depressive disorder
Started antidepressant medication within past 6 weeks
Substance abuse/dependence (past 4 months)
Regular and frequent cannabis use (> twice/week regularly)
Currently clinically significant suicidal ideation or HAM-D >24
History or current psychosis or bipolar disorder
Pregnant or breastfeeding
Significant untreated insomnia (score >3 on HAM-D insomnia items)
Currently taking psychostimulant medication or past nonresponse to modafinil
Has no alternative viable antiretroviral regimen after the current one
Left ventricular hypertrophy; mitral valve prolapse

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00737204

Locations

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

Principal Investigator:

Judith G. Rabkin, Phd, MPH

Columbia University

More Information

Publications:

Rabkin JG, McElhiney MC, Rabkin R. Treatment of HIV-related fatigue with armodafinil: a placebo-controlled randomized trial. Psychosomatics. 2011 Jul-Aug;52(4):328-36.

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
ClinicalTrials.gov Identifier:	NCT00737204 History of Changes
Other Study ID Numbers:	R01 MH072383-02,#4839/5892R, R01MH072383-02, DAHBR 9A-ASNK
Study First Received:	August 14, 2008
Last Updated:	December 29, 2011
Health Authority:	United States: Federal Government

Keywords provided by New York State Psychiatric Institute:

HIV
AIDS
Armodafinil
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 February 09, 2012