The Treatment of Insomnia in Patients With HIV Disease

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ClinicalTrials.gov Identifier: NCT00465972

Recruitment Status : Completed

First Posted : April 27, 2007

Results First Posted : July 30, 2013

Last Update Posted : July 30, 2013

Sponsor:

Information provided by (Responsible Party):

Duke University

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
HIV Infections Insomnia	Drug: Doxepin Drug: Temazepam Drug: Placebo	Phase 4

Detailed Description:

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.

Study Design


Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	44 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
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.
Study Start Date :	March 2007
Actual Primary Completion Date :	August 2010
Actual Study Completion Date :	August 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Temazepam Doxepin hydrochloride Doxepin

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: Placebo Placebo	Drug: Placebo Placebo capsule nightly for duration of study
Active Comparator: 2 Doxepin	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
Active Comparator: 3 Temazepam	Drug: Temazepam Temazepam capsule 15 mg po nightly x duration of study

Outcome Measures

Primary Outcome Measures :

Response: Change in Insomnia Severity Rating Scale at 3 Months. [ Time Frame: Baseline and 3 months ]
Insomnia Severity Index; It is a measure of Insomnia Severity; A higher number indicates greater severity of insomnia. Range of possible score totals is 0-28.

Secondary Outcome Measures :

Change in Piper Fatigue Scale at 3 Months [ Time Frame: Baseline and 3 months ]
A 22 item scale measuring level of fatigue, with possible totals ranging from 22-220. A higher number indicates greater severity of fatigue.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 69 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Insomnia
HIV Seropositive
Stable HIV Disease

Exclusion Criteria:

Other psychiatric illnesses
Unstable HIV disease

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00465972

Locations


United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710

Sponsors and Collaborators

Duke University

Investigators


Principal Investigator:	Andrew D Krystal, MD	Duke University

More Information

Publications:

Reid S, Dwyer J. Insomnia in HIV infection: a systematic review of prevalence, correlates, and management. Psychosom Med. 2005 Mar-Apr;67(2):260-9. Review.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Low Y, Preud'homme X, Goforth HW, Omonuwa T, Krystal AD. The association of fatigue with depression and insomnia in HIV-seropositive patients: a pilot study. Sleep. 2011 Dec 1;34(12):1723-6. doi: 10.5665/sleep.1446.


Responsible Party:	Duke University
ClinicalTrials.gov Identifier:	NCT00465972 History of Changes
Other Study ID Numbers:	8899
First Posted:	April 27, 2007 Key Record Dates
Results First Posted:	July 30, 2013
Last Update Posted:	July 30, 2013
Last Verified:	May 2013

Keywords provided by Duke University:


HIV Insomnia Cytokines Adherence

Additional relevant MeSH terms:


HIV Infections Sleep Initiation and Maintenance Disorders Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Sleep Disorders, Intrinsic Dyssomnias Sleep Wake Disorders Nervous System Diseases Mental Disorders	Doxepin Temazepam Antidepressive Agents, Tricyclic Antidepressive Agents Psychotropic Drugs Histamine Antagonists Histamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Hypnotics and Sedatives Central Nervous System Depressants Anti-Anxiety Agents Tranquilizing Agents GABA Modulators

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