Status:
COMPLETED
Effectiveness of Modafinil for Treating Fatigue in Adults With HIV/AIDS
Lead Sponsor:
New York State Psychiatric Institute
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
HIV Infections
Fatigue
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
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.
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
115 Patients enrolled
Trial Details
Trial ID
NCT00118378
Start Date
December 1 2004
End Date
November 1 2010
Last Update
May 10 2017
Active Locations (1)
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1
New York State Psychiatric Institute
New York, New York, United States, 10032