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

HIV Infections Clinical Trial

Official title:

Modafinil Treatment for Fatigue in HIV+ Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00118378
• Other study ID #: #4839
• Secondary ID: R01MH072383-01DA
• Status: Completed
• Phase: Phase 4
• First received: July 6, 2005
• Last updated: June 6, 2014
• Start date: December 2004
• Est. completion date: November 2010

Study information

• Verified date: March 2013
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: November 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fatigue
• HIV Infections

Intervention

Drug:
• Modafinil
50 mg per day, increasing to 200 mg per day as clinically indicated
• Placebo
50 mg per day, increasing to 200 mg per day as clinically indicated

Locations

Country	Name	City	State
United States	New York State Psychiatric Institute	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York State Psychiatric Institute	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

Rabkin JG, McElhiney MC, Rabkin R, McGrath PJ. Modafinil treatment for fatigue in HIV/AIDS: a randomized placebo-controlled study. J Clin Psychiatry. 2010 Jun;71(6):707-15. doi: 10.4088/JCP.09m05171bro. Epub 2010 May 4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fatigue Severity Scale (FSS)	The FSS is a 9-item self-report scale that measures the impact of fatigue on everyday functioning. Each item is rated on a scale of 1 to 7. Total scores range from 9 to 63, with a higher value indicating greater impairment due to fatigue.	Measured at baseline and Week 4	No
Primary	Role Function Scale Outcome	The Role Function Scale includes 10 items drawn from the Short Form 36-item Health Survey (SF-36) and other SF versions. It is intended to assess the extent to which fatigue has a behavioral impact on daily activities. Scores of frequency in the past week, on a 5-point scale, are summed with higher scores signifying greater role impairment. Scores range from 10 to 50.	Measured at baseline and Week 4	No
Secondary	CD4 Cell Count	CD4 cell count is a laboratory marker providing an indication of immune functioning. Blood was drawn for this measure at baseline and week 4. The reference range for CD4 cell count is 490-1740, and a clinically significant change is defined as a change of >= 100 cells. A higher number is associated with better immune functioning.	Measured at baseline and Week 4	Yes
Secondary	HIV RNA Viral Load	HIV RNA viral load assay is a laboratory measure indicating viral activity. Because of the large range of possible values (50-100,000 copies), this measure is presented in log10. We entered the log10 value of 1.69 when the laboratory result stated "under 50 copies," which was the assay's lowest limit of detectability during the study.	Measured at baseline and Week 4	Yes

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