Trial record 11 of 18 for: " April 11, 2007":" May 11, 2007"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

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The Treatment of Insomnia in Patients With HIV Disease

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Duke University

ClinicalTrials.gov Identifier:

NCT00465972

First received: April 25, 2007

Last updated: August 5, 2012

Last verified: August 2011

History of Changes

Purpose

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
HIV Infections Insomnia	Drug: Doxepin Drug: Temazepam Drug: Placebo	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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.

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Temazepam Doxepin hydrochloride Doxepin

U.S. FDA Resources

Further study details as provided by Duke University:

Primary Outcome Measures:

Response: Effect upon an insomnia severity rating scale at 3 and 6 months. [ Time Frame: 2 weeks, 4 weeks, 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Response: effect upon cytokine analysis, fatigue, immune measures, and adherence. [ Time Frame: 2 weeks, 4 weeks, 3 months ] [ Designated as safety issue: No ]

Enrollment:	49
Study Start Date:	March 2007
Study Completion Date:	August 2010
Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: 1 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

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.

Eligibility

Ages Eligible for Study:	18 Years to 69 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Insomnia
HIV Seropositive
Stable HIV Disease

Exclusion Criteria:

Other psychiatric illnesses
Unstable HIV disease

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00465972

Locations

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

Sponsors and Collaborators

Duke University

Investigators

Principal Investigator:	Harold W Goforth, MD	Duke University
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.

Additional 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.

Responsible Party:	Duke University
ClinicalTrials.gov Identifier:	NCT00465972 History of Changes
Other Study ID Numbers:	8899
Study First Received:	April 25, 2007
Last Updated:	August 5, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by Duke University:

HIV
Insomnia
Cytokines
Adherence

Additional relevant MeSH terms:

HIV Infections
Acquired Immunodeficiency Syndrome
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
Slow Virus Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders

Nervous System Diseases
Mental Disorders
Doxepin
Temazepam
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013

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