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

NCT ID: NCT00737204

Last Updated: 2014-06-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-06-30
• Study Completion Date: 2010-09-30

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.

Conditions

HIV Infections; Fatigue

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Armodafinil

Participants 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.

Group Type: EXPERIMENTAL

Armodafinil

Intervention Type: DRUG

Participants will receive 50 mg of armodafinil per day, increasing to 250 mg per day as clinically indicated.

Placebo

Participants 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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Participants will receive placebo pills matched to the active armodafinil and according to the same dosing strategy

Interventions

Armodafinil

Participants will receive 50 mg of armodafinil per day, increasing to 250 mg per day as clinically indicated.

Intervention Type: DRUG

Placebo

Participants will receive placebo pills matched to the active armodafinil and according to the same dosing strategy

Intervention Type: DRUG

Other Intervention Names

Nuvigil; Sugar pill

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

New York State Psychiatric Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Judith G. Rabkin, Phd, MPH

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

New York State Psychiatric Institute

New York, New York, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 15641875 (View on PubMed)

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.

Reference Type: RESULT

PMID: 21777715 (View on PubMed)

Other Identifiers

R01MH072383-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

#4839/5892R

Identifier Type: -

Identifier Source: org_study_id