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| ID | Type | Description | Link |
|---|---|---|---|
| R01MH072383-01 | U.S. NIH Grant/Contract | View source | |
| DAHBR 9A-ASNM |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Modafinil | Experimental | Participants will take modafinil for 4 weeks. |
|
| Placebo | Placebo Comparator | Participants will take placebo for 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Modafinil | Drug | 50 mg per day, increasing to 200 mg per day as clinically indicated |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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. | |
| 20492840 | Result | 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. |
| Label | URL |
|---|---|
| Click here for a related study currently recruiting participants. | View source |
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Patients were enrolled from January 2005 until December 2008.
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| ID | Title | Description |
|---|---|---|
| FG000 | Modafinil | Participants will take modafinil for 4 weeks. If responsive, participants will be offered 8 additional weeks of modafinil. |
| FG001 | Placebo | Participants will take placebo for 4 weeks, if not responsive, a 12-week course of modafinil will be offered. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Modafinil | Participants will take modafinil for 4 weeks. If responsive, participants will be offered 8 additional weeks of modafinil. |
| BG001 | Placebo | Participants will take placebo for 4 weeks, if not responsive, a 12-week course of modafinil will be offered. |
| 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) | 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. | The WEEK 4 outcome analyses are based on an intention to treat sample which includes the 10 dropouts (2 on Modafinil and 8 on Placebo), using the last data point brought forward. | Posted | Mean | Standard Deviation | units on a scale | Measured at baseline and Week 4 |
|
Weeks 1-4 during the double-blind phase of the study.
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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 | Modafinil | Participants will take modafinil for 4 weeks. If responsive, participants will be offered 8 additional weeks of modafinil. |
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This study was conducted at a single site in an urban setting where most patients have good access to medical care. Women were under-represented despite outreach efforts.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Judith Rabkin | New York State Psychiatric Institute | 212.543.5762 | 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 | 50 mg per day, increasing to 200 mg per day as clinically indicated |
|
|
| 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 |
| 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 randomized to placebo for 4 weeks, if not responsive, a 12-week course of modafinil will be offered. |
|
|
|
| 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. | The WEEK 4 outcome analyses are based on an intention to treat sample which includes the 10 dropouts (2 on Modafinil and 8 on Placebo), 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 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. | 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 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. | 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 |
| 62 |
| 0 |
| 62 |
| EG001 | Placebo | Participants will take placebo for 4 weeks, if not responsive, a 12-week course of modafinil will be offered. | 0 | 53 | 0 | 53 |
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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 |