Modafinil for Fatigue in HIV/AIDS

Condition(s) targeted: HIV Infections; Fatigue

Intervention: Modafinil (Drug); Placebo (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

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.

Official title: Modafinil Treatment for Fatigue in HIV+ Patients

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

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 medication. Fatigue in HIV is associated with disability and diminished quality of life. It may be caused by antiretrovirals (ARVs) or by the virus itself. This study will the medication modafinil can reduce fatigue in HIV/AIDS patients.

This study will last 12 weeks. Participants will be randomly assigned to receive either modafinil or placebo daily for 4 weeks. Participants who show an improvement in symptoms will receive modafinil for an additional 8 weeks. Participants who do not respond to modafinil will have the opportunity to receive other drug treatments. 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.

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

Criteria:

Inclusion Criteria:

- HIV infected

- Clinically significant fatigue for at least 3 months prior to 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 prior to

study entry

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

- Untreated major depression

- Initiation of antidepressant medication within 6 weeks prior to 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

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
Martin McElhiney, PhD, Phone: 212 543 5331, Email: Mcelhin@pi.cpmc.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: January 2005
Ending date: February 2010
Last updated: April 1, 2008