Effectiveness of Armodafinil for Treating Fatigue in Adults With HIV/AIDS
Armodafinil Treatment for Fatigue in HIV+ Patients
2 other identifiers
interventional
70
1 country
1
Brief Summary
This study will determine whether armodafinil (Nuvigil), an FDA approved medication, is effective in reducing fatigue in adults with HIV/AIDS.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 hiv-infections
Started Jun 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
August 14, 2008
CompletedFirst Posted
Study publicly available on registry
August 18, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2010
CompletedResults Posted
Study results publicly available
June 12, 2014
CompletedJune 12, 2014
March 1, 2013
1.8 years
August 14, 2008
March 13, 2013
June 11, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Fatigue Severity Scale(FSS) Outcome
The FSS is a 9-item self-report scale that measures the impact of fatigue on everyday functioning. Each item is rated on a scale of 1 to 7. Total scores range from 9-63, with a higher score indicating greater impairment due to fatigue.
Measured at baseline and Weeks 4
Role Function Scale
The Role Function Scale includes 10 items drawn from the Short Form 36-item Survey (SF-36) and other SF versions. It is intended to assess the extent to which fatigue has a behavioral impact on daily activities. Scores of frequency in the past week, on a 5-point scale, are summed with higher scores signifying greater role impairment. Scores range from 10-50.
Measured at Baseline and Week 4
Secondary Outcomes (2)
CD4 Cell Count
Measured at baseline and Week 4
HIV Viral Load
Measured at baseline and Week 4
Study Arms (2)
Armodafinil
EXPERIMENTALParticipants will take armodafinil for 4 weeks. The dose will be titrated up from 50mg to 250mg per day as clinically indicated, using 50mg tablets. If responsive, participants will be offered 12 additional weeks of armodafinil.
Placebo
PLACEBO COMPARATORParticipants will receive placebo pills for 4 weeks. Placebo tablets that match the 50mg active medication tablets will given following the same dosing strategy as Arm 1. The dose will be titrated from 1 placebo tablet daily to 5 tablets daily as clinically indicated. Non-responders to placebo will then be offered 16 weeks of active medication.
Interventions
Participants will receive 50 mg of armodafinil per day, increasing to 250 mg per day as clinically indicated.
Participants will receive placebo pills matched to the active armodafinil and according to the same dosing strategy
Eligibility Criteria
You may qualify if:
- Ages 18-75
- HIV+
- Clinically significant fatigue (score of 4.5+ on Fatigue Severity Scale, plus impairment on 1+ categories of Role Function Scale)
- Fatigue duration for 3+ months
- English-speaking
- Able to give informed consent
- Fecund women uses barrier method of contraception
You may not qualify if:
- Primary care doctor does not approve of study participation
- Unstable medical condition (e.g. liver failure; cirrhosis, new onset opportunistic infection in past month)
- Untreated hypogonadism, except for men for whom testosterone replacement is medically contraindicated (serum testosterone below the reference range)
- Untreated hypothyroidism (Thyroid Stimulating Hormone 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 Hamilton Depression Scale (HAM-D) score \>24
- History or current psychosis or bipolar disorder
- Pregnant or breastfeeding
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
New York State Psychiatric Institute
New York, New York, 10032, United States
Related Publications (2)
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. doi: 10.4088/jcp.v65n1215.
PMID: 15641875BACKGROUNDRabkin 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. doi: 10.1016/j.psym.2011.02.005.
PMID: 21777715RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Judith G. Rabkin, Ph.D., M.P.H.
- Organization
- New York State Psychiatric Institute
Study Officials
- PRINCIPAL INVESTIGATOR
Judith G. Rabkin, Phd, MPH
Columbia University
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 14, 2008
First Posted
August 18, 2008
Study Start
June 1, 2008
Primary Completion
April 1, 2010
Study Completion
September 1, 2010
Last Updated
June 12, 2014
Results First Posted
June 12, 2014
Record last verified: 2013-03