Expired Study
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New York, New York 10032


Purpose:

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.


Study summary:

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. This study will determine if 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.


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 [O.I.] 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 [TSH] 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 Rating Scale (HAM-D) >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


NCT ID:

NCT00118378


Primary Contact:

Principal Investigator
Judith G. Rabkin, PhD, MPH
Columbia University


Backup Contact:

N/A


Location Contact:

New York, New York 10032
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 10, 2017

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