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Sponsored by: |
Duke University |
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Information provided by: | Duke University |
ClinicalTrials.gov Identifier: | NCT00465972 |
This study is designed to evaluate the efficacy of two commonly prescribed sleep aids for use in patients who are HIV positive and suffer from insomnia.
Condition | Intervention | Phase |
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HIV Infections Insomnia |
Drug: Doxepin Drug: Temazepam Drug: Placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | A Randomized, Double-Blind, Placebo Controlled Study to Assess the Efficacy and Safety of Doxepin and Temazepam in HIV Seropositive Patients With Insomnia. |
Estimated Enrollment: | 60 |
Study Start Date: | March 2007 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Placebo Comparator
Placebo
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Drug: Placebo
Placebo capsule nightly for duration of study
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2: Active Comparator
Doxepin
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Drug: Doxepin
Doxepin 10 mg po nightly x duration of study length OR Temazepam 15 mg po nightly x duration of study length OR Placebo nightly x duration of study length
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3: Active Comparator
Temazepam
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Drug: Temazepam
Temazepam capsule 15 mg po nightly x duration of study
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Insomnia is a disorder defined as persistent difficulty falling asleep, staying asleep or non-restorative sleep which is associated with diminished daytime function without any identifiable underlying cause. This condition is extremely common among HIV infected individuals and can lead to significant distress and reduction in the quality of life. The mechanisms for disrupted sleep in this population are diverse, including potential direct effects of the tat protein upon the sleep centers in the central nervous system. Insomnia has been documented to be one of the most common psychiatric disorders in HIV disease, but no trial has systematically examined the efficacy of available hypnotic agents, which are commonly used in this population.
Comparison(s): Two commonly prescribed hypnotic agents used for insomnia will be compared to placebo over a 6 month treatment study.
Ages Eligible for Study: | 18 Years to 69 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Linda Ollis | 919-681-8789 | ollis001@mc.duke.edu |
Contact: Tamara Hayes | 919-681-8797 |
United States, North Carolina | |
Duke University Medical Center | Recruiting |
Durham, North Carolina, United States, 27710 | |
Contact: Harold W Goforth, MC 919-681-8742 harold.goforth@duke.edu |
Principal Investigator: | Harold W Goforth, MD | Duke University |
Principal Investigator: | Andrew D Krystal, MD | Duke University |
Responsible Party: | Duke University Medical Center ( Harold Goforth, M.D./Assistant Professor of Psychiatry ) |
Study ID Numbers: | 8899 |
Study First Received: | April 25, 2007 |
Last Updated: | January 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00465972 |
Health Authority: | United States: Institutional Review Board |
HIV Insomnia Cytokines Adherence |
Sleep Initiation and Maintenance Disorders Sexually Transmitted Diseases, Viral Acquired Immunodeficiency Syndrome Temazepam Sleep Disorders Dyssomnias Immunologic Deficiency Syndromes Histamine |
Sleep Disorders, Intrinsic Virus Diseases HIV Infections Mental Disorders Sexually Transmitted Diseases Doxepin Histamine phosphate Retroviridae Infections |
RNA Virus Infections Neurotransmitter Agents Tranquilizing Agents Slow Virus Diseases Immune System Diseases Molecular Mechanisms of Pharmacological Action GABA Modulators Nervous System Diseases Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Histamine Agents |
Infection Pharmacologic Actions Antidepressive Agents, Tricyclic Histamine Antagonists Therapeutic Uses Hypnotics and Sedatives Lentivirus Infections GABA Agents Anti-Anxiety Agents Central Nervous System Agents Antidepressive Agents |