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| Sponsored by: |
National Institute of Mental Health (NIMH) |
| Information provided by: | National Institute of Mental Health (NIMH) |
| ClinicalTrials.gov Identifier: | NCT00737204 |
Purpose
This study will determine whether armodafinil (Nuvigil), an FDA approved medication, is effective in reducing fatigue in adults with HIV/AIDS.
| Condition | Intervention | Phase |
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HIV Infections Fatigue |
Drug: Armodafinil |
Phase IV |
| MedlinePlus related topics: | AIDS Depression |
| Drug Information available for: | Armodafinil |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Parallel Assignment, Efficacy Study |
| Official Title: | Armodafinil Treatment for Fatigue in HIV+ Patients |
| Estimated Enrollment: | 50 |
| Study Start Date: | June 2008 |
| Estimated Study Completion Date: | February 2010 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
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1. Armodafinil, responsive: Experimental
Participants will receive armodafinil for 4 weeks. If responsive, participants will be offered 12 additional weeks of armodafinil.
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Drug: Armodafinil
Participants will receive 50 mg of armodafinil per day, increasing to 200 mg per day as clinically indicated.
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2. Placebo, Armodafinil: Placebo Comparator
Participants will receive a placebo pill for 4 weeks, then a 16-week course of armodafinil.
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Drug: Armodafinil
Participants will receive 50 mg of armodafinil per day, increasing to 200 mg per day as clinically indicated.
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3. Armodafinil, nonresponsive: Active Comparator
Participants will receive armodafinil for 4 weeks. If nonresponsive, participants will be offered 12 weeks of an alternative treatment.
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Drug: Armodafinil
Participants will receive 50 mg of armodafinil per day, increasing to 200 mg per day as clinically indicated.
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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.
This study will last 18 weeks. Participants will be randomly assigned to receive either armodafinil or a placebo daily for 4 weeks. Participants who show improvements in symptoms will be offered armodafinil for an additional 12 weeks. Participants who did not receive armodafinil will be offered armodafinil for 16 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.
Eligibility
| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Judith G. Rabkin, PhD, MPH | 212-543-5762 | jgr1@columbia.edu |
| United States, New York | |||||
| New York State Psychiatric Institute | Recruiting | ||||
| New York, New York, United States, 10032 | |||||
| Contact: Judith G. Rabkin, PhD, MPH 212-543-5762 jgr1@columbia.edu | |||||
| Principal Investigator: Judith G. Rabkin, PhD, MPH | |||||
| Principal Investigator: | Judith G. Rabkin, Phd, MPH | Columbia University |
More Information
| Responsible Party: | New York State Psychiatric Institute ( Judith Rabkin, PhD ) |
| Study ID Numbers: | R01 MH72383 - Substudy 1, DAHBR 9A-ASNK |
| First Received: | August 14, 2008 |
| Last Updated: | August 21, 2008 |
| ClinicalTrials.gov Identifier: | NCT00737204 |
| Health Authority: | United States: Federal Government |
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