The Treatment of Insomnia in Patients With HIV Disease - Full Text View

Sponsor:	Duke University
Information provided by:	Duke University
ClinicalTrials.gov Identifier:	NCT00465972

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 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.

Resource links provided by NLM:

MedlinePlus related topics: 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 ]

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
1: Placebo Comparator Placebo	Drug: Placebo Placebo capsule nightly for duration of study
2: Active Comparator 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
3: Active Comparator 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

Contacts

Contact: Linda Ollis	919-681-8789	ollis001@mc.duke.edu
Contact: Tamara Hayes	919-681-8797

Locations

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

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.

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 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Duke University:

HIV
Insomnia
Cytokines
Adherence

Additional relevant MeSH terms:

Sleep Initiation and Maintenance Disorders
Sexually Transmitted Diseases, Viral
Neurotransmitter Agents
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
GABA Modulators
Physiological Effects of Drugs
Psychotropic Drugs
Sleep Disorders
Infection
Sleep Disorders, Intrinsic
Mental Disorders
Therapeutic Uses
Hypnotics and Sedatives
Doxepin

Retroviridae Infections
Antidepressive Agents
RNA Virus Infections
Tranquilizing Agents
Immune System Diseases
Acquired Immunodeficiency Syndrome
Nervous System Diseases
Temazepam
Central Nervous System Depressants
Dyssomnias
Histamine Agents
Immunologic Deficiency Syndromes
Pharmacologic Actions
Antidepressive Agents, Tricyclic
Virus Diseases

ClinicalTrials.gov processed this record on November 27, 2009