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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00118378 |
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.
Condition | Intervention | Phase |
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HIV Infections Fatigue |
Drug: Modafinil |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Modafinil Treatment for Fatigue in HIV+ Patients |
Estimated Enrollment: | 120 |
Study Start Date: | January 2005 |
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. Modafinil, responsive: Experimental
Participants will take modafinil for 4 weeks. If responsive, participants will be offered 8 additional weeks of modafinil.
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Drug: Modafinil
50 mg per day, increasing to 200 mg per day as clinically indicated
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2. Placebo, Modafinil: Placebo Comparator
Participants will take placebo for 4 weeks, then a 12-week course of modafinil.
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Drug: Modafinil
50 mg per day, increasing to 200 mg per day as clinically indicated
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3. Modafinil, nonresponsive: Experimental
Participants will take modafinil for 4 weeks. If nonresponsive, they will be offered an alternative treatment.
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Drug: Modafinil
50 mg 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. 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.
For information on an identical study using a related drug, please follow this URL:
http://clinicaltrials.gov/show/NCT00737204
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, New York | |
New York State Psychiatric Institute | |
New York, New York, United States, 10032 |
Principal Investigator: | Judith G. Rabkin, PhD, MPH | Columbia University |
Responsible Party: | New York State Psychiatric Institute ( Judith Rabkin, PhD ) |
Study ID Numbers: | R01 MH072383-01, DAHBR 9A-ASNM |
Study First Received: | July 6, 2005 |
Last Updated: | February 19, 2009 |
ClinicalTrials.gov Identifier: | NCT00118378 History of Changes |
Health Authority: | United States: Federal Government |
HIV AIDS Modafinil Depression |
Sexually Transmitted Diseases, Viral Fatigue Depression Acquired Immunodeficiency Syndrome Central Nervous System Stimulants Depressive Disorder Neuroprotective Agents |
Immunologic Deficiency Syndromes Modafinil Virus Diseases Signs and Symptoms HIV Infections Sexually Transmitted Diseases Retroviridae Infections |
RNA Virus Infections Sexually Transmitted Diseases, Viral Fatigue Slow Virus Diseases Immune System Diseases Physiological Effects of Drugs Acquired Immunodeficiency Syndrome Central Nervous System Stimulants Infection Protective Agents Neuroprotective Agents |
Pharmacologic Actions Modafinil Immunologic Deficiency Syndromes Virus Diseases Signs and Symptoms HIV Infections Therapeutic Uses Sexually Transmitted Diseases Lentivirus Infections Central Nervous System Agents Retroviridae Infections |