Overview

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

Status:
Completed
Trial end date:
2010-11-01
Target enrollment:
0
Participant gender:
All
Summary
This study will determine whether modafinil (Provigil®), a medication approved for the treatment of narcolepsy, 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 [O.I.] 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 [TSH] 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 Rating Scale
(HAM-D) >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