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

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:

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: Change in Insomnia Severity Rating Scale at 3 Months. [ Time Frame: Baseline and 3 months ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
A 22 item scale measuring level of fatigue, with possible totals ranging from 22-220. A higher number indicates greater severity of fatigue.


Enrollment:	44
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: 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

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 (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:	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
Study First Received:	April 25, 2007
Results First Received:	December 12, 2012
Last Updated:	July 26, 2013
Health Authority:	United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 28, 2016