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Effectiveness of Armodafinil for Treating Fatigue in Adults With HIV/AIDS

Information source: New York State Psychiatric Institute
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV Infections; Fatigue

Intervention: Armodafinil (Drug); Placebo (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: New York State Psychiatric Institute

Official(s) and/or principal investigator(s):
Judith G. Rabkin, Phd, MPH, Principal Investigator, Affiliation: Columbia University


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

Clinical Details

Official title: Armodafinil Treatment for Fatigue in HIV+ Patients

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

Fatigue Severity Scale(FSS) Outcome

Role Function Scale

Secondary outcome:

CD4 Cell Count

HIV Viral Load

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. Participants will be randomly assigned to receive either armodafinil or a placebo daily for 4 weeks. Participants randomized to active medication and who show improvements in symptoms will be offered armodafinil for an additional 12 weeks. For them, the study duration is 16 weeks. Participants who did not receive armodafinil will be offered armodafinil for 16 weeks. For these participants, the study duration is 20 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.


Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.


Inclusion Criteria: 1. Ages 18-75 2. HIV+ 3. Clinically significant fatigue (score of 4. 5+ on Fatigue Severity Scale, plus impairment on 1+ categories of Role Function Scale) 4. Fatigue duration for 3+ months 5. English-speaking 6. Able to give informed consent 7. Fecund women uses barrier method of contraception Exclusion Criteria: 1. Primary care doctor does not approve of study participation 2. Unstable medical condition (e. g. liver failure; cirrhosis, new onset opportunistic infection in past month) 3. Untreated hypogonadism, except for men for whom testosterone replacement is medically contraindicated (serum testosterone below the reference range) 4. Untreated hypothyroidism (Thyroid Stimulating Hormone over 5 IUI/mL) 5. Untreated and uncontrolled hypertension 6. Clinically significant anemia (hematocrit <30%) 7. Started testosterone or nandrolone in past 6 weeks 8. Started or changed an antiretroviral regimen in past 4 weeks if fatigue predated the change; otherwise, started or changed regimen in past 2 months 9. Untreated or under-treated major depressive disorder 10. Started antidepressant medication within past 6 weeks 11. Substance abuse/dependence (past 4 months) 12. Regular and frequent cannabis use (> twice/week regularly) 13. Currently clinically significant suicidal ideation or Hamilton Depression Scale (HAM-D) score >24 14. History or current psychosis or bipolar disorder 15. Pregnant or breastfeeding 16. Significant untreated insomnia (score >3 on HAM-D insomnia items) 17. Currently taking psychostimulant medication or past nonresponse to modafinil 18. Has no alternative viable antiretroviral regimen after the current one 19. Left ventricular hypertrophy; mitral valve prolapse

Locations and Contacts

New York State Psychiatric Institute, New York, New York 10032, United States
Additional Information

Related 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.

Starting date: June 2008
Last updated: June 11, 2014

Page last updated: August 23, 2015

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