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

Completed · Phase 4 · Has a placebo group

Conditions studied: HIV Infections, Fatigue

In brief

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.

Key facts

Study ID

NCT00118378

Run by

New York State Psychiatric Institute

People needed

115

Starts

2004-12-01

Expected to finish

2010-11-01

Last updated by the study team

2017-05-10

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Ages 18-75
• HIV+
• Clinically significant fatigue (score of 4.5+ on Fatigue Severity Scale, plus impairment on 1+ categories of Role Function Scale)
• Fatigue duration for 3+ months
• English-speaking
• Able to give informed consent
• Fecund women uses barrier method of contraception

You may not qualify if…

• Primary care doctor does not approve of study participation
• Unstable medical condition (e.g. liver failure;cirrhosis, new onset opportunistic infection [O.I.] in past month)
• Untreated hypogonadism, except for men for whom testosterone replacement is medically contraindicated (serum testosterone below the reference range)
• Untreated hypothyroidism (thyroid stimulating hormone [TSH] over 5 IUI/mL)
• Untreated and uncontrolled hypertension
• Clinically significant anemia (hematocrit <30%)
• Started testosterone or nandrolone in past 6 weeks
• Started or changed an antiretroviral regimen in past 4 weeks if fatigue predated the change; otherwise, started or changed regimen in past 2 months
• Untreated or under-treated major depressive disorder
• Started antidepressant medication within past 6 weeks
• Substance abuse/dependence (past 4 months)
• Regular and frequent cannabis use (> twice/week regularly)
• Currently clinically significant suicidal ideation or Hamilton Depression Rating Scale (HAM-D) >24
• History or current psychosis or bipolar disorder
• Pregnant or breastfeeding
• Significant untreated insomnia (score >3 on HAM-D insomnia items)
• Currently taking psychostimulant medication or past nonresponse to modafinil
• Has no alternative viable antiretroviral regimen after the current one
• Left ventricular hypertrophy; mitral valve prolapse

Where it is running

• New York State Psychiatric Institute — New York, New York, United States

Full record on ClinicalTrials.gov

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