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

Condition(s) targeted: HIV Infections; Fatigue

Intervention: Armodafinil (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: National Institute of Mental Health (NIMH)

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

Overall contact:
Judith G. Rabkin, PhD, MPH, Phone: 212-543-5762, Email: jgr1@columbia.edu

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

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 outcome

Role function scale outcome

Secondary outcome:

CD4 cell count

HIV viral load

Hamilton rating scale for depression

Beck Depression Inventory II

Cognitive function

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.

This study will last 18 weeks. Participants will be randomly assigned to receive either armodafinil or a placebo daily for 4 weeks. Participants who show improvements in symptoms will be offered armodafinil for an additional 12 weeks. Participants who did not receive armodafinil will be offered armodafinil for 16 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.

For information on a related study, please follow this URL:

http://clinicaltrials. gov/show/NCT00118378

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- HIV infected

- Clinically significant fatigue for at least 3 months before study entry

- Able to speak English

- Willing to use acceptable methods of contraception

Exclusion Criteria:

- Insufficient production of thyroid hormones (hypothyroidism) or untreated

malfunctioning of testes or ovaries (hypogonadism)

- Uncontrolled hypertension

- Clinically significant anemia

- Initiation of testosterone or nandrolone (a steroid) treatment within 6 weeks before

study entry

- Began or changed an ARV regimen within 12 weeks before study entry

- Untreated major depression

- Initiation of antidepressant medication within 6 weeks before study entry

- Current substance abuse or dependence that may interfere with the study

- Regular cannabis use

- Previous or current nondrug-induced psychosis or bipolar disorder

- Current use of psychostimulant medication

- Previous nonresponse to an adequate trial of modafinil

- Any unstable medical condition

- Previously failed ARV regimens and currently on last viable ARV regimen

- Pregnancy or breastfeeding

- Primary care doctor does not approve of study participation

Judith G. Rabkin, PhD, MPH, Phone: 212-543-5762, Email: jgr1@columbia.edu

New York State Psychiatric Institute, New York, New York 10032, United States; Recruiting
Judith G. Rabkin, PhD, MPH, Phone: 212-543-5762, Email: jgr1@columbia.edu
Judith G. Rabkin, PhD, MPH, Principal Investigator

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: March 16, 2009