The Treatment of Insomnia in Patients With HIV Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00465972
Recruitment Status : Completed
First Posted : April 27, 2007
Results First Posted : July 30, 2013
Last Update Posted : July 30, 2013
Information provided by (Responsible Party):
Duke University

April 25, 2007
April 27, 2007
December 12, 2012
July 30, 2013
July 30, 2013
March 2007
August 2010   (Final data collection date for primary outcome measure)
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.
Response: Effect upon an insomnia severity rating scale at 3 and 6 months.
Complete list of historical versions of study NCT00465972 on Archive Site
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.
Response: effect upon cytokine analysis, fatigue, immune measures, and adherence.
Not Provided
Not Provided
The Treatment of Insomnia in Patients With HIV Disease
A Randomized, Double-blind, Placebo Controlled Study to Assess the Efficacy and Safety of Doxepin and Temazepam in HIV Seropositive Patients With Insomnia.
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.

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.

Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • HIV Infections
  • Insomnia
  • 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
  • Drug: Temazepam
    Temazepam capsule 15 mg po nightly x duration of study
  • Drug: Placebo
    Placebo capsule nightly for duration of study
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Active Comparator: 2
    Intervention: Drug: Doxepin
  • Active Comparator: 3
    Intervention: Drug: Temazepam

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
August 2010
August 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Insomnia
  • HIV Seropositive
  • Stable HIV Disease

Exclusion Criteria:

  • Other psychiatric illnesses
  • Unstable HIV disease
Sexes Eligible for Study: All
18 Years to 69 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Duke University
Duke University
Not Provided
Principal Investigator: Andrew D Krystal, MD Duke University
Duke University
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP