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| ID | Type | Description | Link |
|---|---|---|---|
| R01MH072383-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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This study will determine whether armodafinil (Nuvigil), an FDA approved medication, is effective in reducing fatigue in adults with HIV/AIDS.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Armodafinil | Experimental | 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. |
|
| Placebo | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Armodafinil | Drug | Participants will receive 50 mg of armodafinil per day, increasing to 250 mg per day as clinically indicated. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Measured at baseline and Weeks 4 |
| 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. | Measured at Baseline and Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Measured at baseline and Week 4 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Judith G. Rabkin, Phd, MPH | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York State Psychiatric Institute | New York | New York | 10032 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15641875 | Background | 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. | |
| 21777715 | Result | 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. |
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A total of 114 patients were screened for eligibility, 25 had medical or psychiatric exclusion criteria, 7 were active substance users, 4 were taking stimulants, 3 were not clinically fatigued, 5 declined participation, and 70 were randomized. Of the 70, 64 completed the 4-week trial.
Patients were recruited from community based organizations and healthcare clinics that provide services to persons with HIV, by placing flyers on bulletin boards and in waiting areas.
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| ID | Title | Description |
|---|---|---|
| FG000 | Armodafinil | Participants will receive armodafinil for 4 weeks. If responsive, participants will be offered 12 additional weeks of armodafinil. Starting dose of armodafinil is 50 mg/day, increased weekly in the absence of clinical response and dose-limiting side effects to a maximum of 250 mg/day. |
| FG001 | Placebo | Participants will receive a placebo pill (matching the active medication) for 4 weeks, then a 16-week course of armodafinil. Starting dose of is one placebo pill/day, increased weekly in the absence of clinical response and dose-limiting side effects to a maximum of 5 placebo pills/day. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Armodafinil | Participants will receive armodafinil for 4 weeks. If responsive, participants will be offered 12 additional weeks of armodafinil. |
| BG001 | Placebo | Participants will receive a placebo pill for 4 weeks, then a 16-week course of armodafinil. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Of the 70 patients randomized, 64 completed the 4-week trial. Data presented are for the 70, using the last data point carried forward (intention to treat). | Posted | Mean | Standard Deviation | units on a scale | Measured at baseline and Weeks 4 |
|
Treatment emergent side effects were assessed at baseline and then weekly during the 4-week trial.
Each potential side effect was rated on a 0 ("No Problems" to 5 ("Severe Problems"). An increase of 2 points during the trial from the baseline score was considered an adverse event.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Armodafinil | Participants will receive armodafinil for 4 weeks. If responsive, participants will be offered 12 additional weeks of armodafinil. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Judith G. Rabkin, Ph.D., M.P.H. | New York State Psychiatric Institute | (646) 774-8075 | jgr1@columbia.edu |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D005221 | Fatigue |
| D000163 | Acquired Immunodeficiency Syndrome |
| D003863 | Depression |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| ID | Term |
|---|---|
| D000077408 | Modafinil |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D001559 | Benzhydryl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Placebo | Drug | Participants will receive placebo pills matched to the active armodafinil and according to the same dosing strategy |
|
|
| 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. | Measured at baseline and Week 4 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Participants will receive a placebo pill for 4 weeks, then a 16-week course of armodafinil. |
|
|
|
| Primary | 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. | The week 4 outcome analyses are based on an intention to treat sample, which includes the 6 dropouts, using the last data point brought forward. | Posted | Mean | Standard Deviation | units on a scale | Measured at Baseline and Week 4 |
|
|
|
|
| Secondary | 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. | Results were included for patients on whom baseline and week 4 labs were drawn. | Posted | Mean | Standard Deviation | Cells/mcL | Measured at baseline and Week 4 |
|
|
|
|
| Secondary | 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. | Results were included for patients on whom baseline and week 4 labs were drawn. | Posted | Mean | Standard Deviation | Log10 copies/mL | Measured at baseline and Week 4 |
|
|
|
| 0 |
| 36 |
| 0 |
| 36 |
| EG001 | Placebo | Participants will receive a placebo pill for 4 weeks, then a 16-week course of armodafinil. | 0 | 34 | 0 | 34 |
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| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012897 | Slow Virus Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D002241 | Carbohydrates |