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Effectiveness of Armodafinil 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
Armodafinil
Placebo
Sponsored by
New York State Psychiatric Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring HIV, AIDS, Armodafinil, Depression

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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 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 Scale (HAM-D) score >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

Sites / Locations

  • New York State Psychiatric Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Armodafinil

Placebo

Arm Description

Participants will take armodafinil for 4 weeks. The dose will be titrated up from 50mg to 250mg per day as clinically indicated, using 50mg tablets. If responsive, participants will be offered 12 additional weeks of armodafinil.

Participants will receive placebo pills for 4 weeks. Placebo tablets that match the 50mg active medication tablets will given following the same dosing strategy as Arm 1. The dose will be titrated from 1 placebo tablet daily to 5 tablets daily as clinically indicated. Non-responders to placebo will then be offered 16 weeks of active medication.

Outcomes

Primary Outcome Measures

Fatigue Severity Scale(FSS) Outcome
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 9-63, with a higher score indicating greater impairment due to fatigue.
Role Function Scale
The Role Function Scale includes 10 items drawn from the Short Form 36-item 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 10-50.

Secondary Outcome Measures

CD4 Cell Count
Cd4 cell count is a laboratory marker providing an indication of immune system functioning. Blood samples were 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 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 transformed to log10 values. 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

First Posted
August 14, 2008
Last Updated
June 11, 2014
Sponsor
New York State Psychiatric Institute
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00737204
Brief Title
Effectiveness of Armodafinil for Treating Fatigue in Adults With HIV/AIDS
Official Title
Armodafinil Treatment for Fatigue in HIV+ Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
September 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 armodafinil (Nuvigil), an FDA approved medication, 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. A related study tested whether modafinil, of which armodafinil is an r-isomer, could reduce fatigue in HIV/AIDS patients. Armodafinil, believed to have a longer duration and greater effect than modafinil, will be tested on the same criteria. Participants will be randomly assigned to receive either armodafinil or a placebo daily for 4 weeks. Participants randomized to active medication and who show improvements in symptoms will be offered armodafinil for an additional 12 weeks. For them, the study duration is 16 weeks. Participants who did not receive armodafinil will be offered armodafinil for 16 weeks. For these participants, the study duration is 20 weeks. Participants who did not benefit from armodafinil will receive alternate treatment options. 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. After completion of 16 weeks, participants responding to armodafinil will be transitioned to the publicly available modafinil over the course of 2 weeks.

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, Armodafinil, Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Armodafinil
Arm Type
Experimental
Arm Description
Participants will take armodafinil for 4 weeks. The dose will be titrated up from 50mg to 250mg per day as clinically indicated, using 50mg tablets. If responsive, participants will be offered 12 additional weeks of armodafinil.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo pills for 4 weeks. Placebo tablets that match the 50mg active medication tablets will given following the same dosing strategy as Arm 1. The dose will be titrated from 1 placebo tablet daily to 5 tablets daily as clinically indicated. Non-responders to placebo will then be offered 16 weeks of active medication.
Intervention Type
Drug
Intervention Name(s)
Armodafinil
Other Intervention Name(s)
Nuvigil
Intervention Description
Participants will receive 50 mg of armodafinil per day, increasing to 250 mg per day as clinically indicated.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Sugar pill
Intervention Description
Participants will receive placebo pills matched to the active armodafinil and according to the same dosing strategy
Primary Outcome Measure Information:
Title
Fatigue Severity Scale(FSS) Outcome
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 9-63, with a higher score indicating greater impairment due to fatigue.
Time Frame
Measured at baseline and Weeks 4
Title
Role Function Scale
Description
The Role Function Scale includes 10 items drawn from the Short Form 36-item 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 10-50.
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 system functioning. Blood samples were 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 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 transformed to log10 values. 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 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 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 Scale (HAM-D) score >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
21777715
Citation
Rabkin JG, McElhiney MC, Rabkin R. Treatment of HIV-related fatigue with armodafinil: a placebo-controlled randomized trial. Psychosomatics. 2011 Jul-Aug;52(4):328-36. doi: 10.1016/j.psym.2011.02.005.
Results Reference
result

Learn more about this trial

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

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