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: July 26, 2013
Last verified: May 2013
  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:


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
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:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
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 July 26, 2014