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

• Status: Completed
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New York State Psychiatric Institute
• Collaborator: National Institute of Mental Health (NIMH)
• Treatments: Armodafinil; Modafinil

Criteria

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