Back to resultsEffectiveness of Modafinil for Treating Fatigue in Adults With HIV/AIDS
Primary Purpose
HIV Infections, Fatigue
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Modafinil
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring HIV, AIDS, Modafinil, Depression
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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
Sites / Locations
- New York State Psychiatric Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Modafinil
Placebo
Arm Description
Participants will take modafinil for 4 weeks.
Participants will take placebo for 4 weeks.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT00118378
First Posted
July 6, 2005
Last Updated
April 3, 2017
Sponsor
New York State Psychiatric Institute
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT00118378
Brief Title
Effectiveness of Modafinil for Treating Fatigue in Adults With HIV/AIDS
Official Title
Modafinil Treatment for Fatigue in HIV+ Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
November 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New York State Psychiatric Institute
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Fatigue
Keywords
HIV, AIDS, Modafinil, Depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
115 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Modafinil
Arm Type
Experimental
Arm Description
Participants will take modafinil for 4 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will take placebo for 4 weeks.
Intervention Type
Drug
Intervention Name(s)
Modafinil
Other Intervention Name(s)
Provigil
Intervention Description
50 mg per day, increasing to 200 mg per day as clinically indicated
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
sugar pill
Intervention Description
50 mg per day, increasing to 200 mg per day as clinically indicated
Primary Outcome Measure Information:
Title
Fatigue Severity Scale (FSS)
Description
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.
Time Frame
Measured at baseline and Week 4
Title
Role Function Scale Outcome
Description
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.
Time Frame
Measured at baseline and Week 4
Secondary Outcome Measure Information:
Title
CD4 Cell Count
Description
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.
Time Frame
Measured at baseline and Week 4
Title
HIV RNA Viral Load
Description
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.
Time Frame
Measured at baseline and Week 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Judith G. Rabkin, PhD, MPH
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York State Psychiatric Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
15641875
Citation
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. doi: 10.4088/jcp.v65n1215.
Results Reference
background
PubMed Identifier
20492840
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.
Results Reference
result
Links:
URL
http://clinicaltrials.gov/ct2/show/NCT00737204?term=rabkin&rank=4
Description
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Effectiveness of Modafinil for Treating Fatigue in Adults With HIV/AIDS
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