Clinical trial NCT00737204: Effectiveness of Armodafinil for Treating Fatigue in Adults With HIV/AIDS
Official title: Armodafinil Treatment for Fatigue in HIV+ Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV Infections
Fatigue
Keywords: HIV
AIDS
Armodafinil
Depression
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2008-08-18
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility 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

Primary outcomes:
measure: Fatigue Severity Scale(FSS) Outcome
timeFrame: Measured at baseline and Weeks 4
measure: Role Function Scale
timeFrame: Measured at Baseline and Week 4
Secondary outcomes:
measure: CD4 Cell Count
timeFrame: Measured at baseline and Week 4
measure: HIV Viral Load
timeFrame: Measured at baseline and Week 4
Other outcomes:
Locations:
city: New York
country: United States
facility: New York State Psychiatric Institute
state: New York
Study officials:
affiliation: Columbia University
name: Judith G. Rabkin, Phd, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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. doi: 10.1016/j.psym.2011.02.005.