The Treatment of Insomnia in Patients With HIV Disease


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.

Full Title of Study: “A Randomized, Double-blind, Placebo Controlled Study to Assess the Efficacy and Safety of Doxepin and Temazepam in HIV Seropositive Patients With Insomnia.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: August 2010

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.


  • 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

Arms, Groups and Cohorts

  • Placebo Comparator: Placebo
    • Placebo
  • Active Comparator: 2
    • Doxepin
  • Active Comparator: 3
    • Temazepam

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Secondary Measures

  • 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.

Participating in This Clinical Trial

Inclusion Criteria

  • Insomnia – HIV Seropositive – Stable HIV Disease Exclusion Criteria:
  • Other psychiatric illnesses – Unstable HIV disease
  • Gender Eligibility: All

    Minimum Age: 18 Years

    Maximum Age: 69 Years

    Are Healthy Volunteers Accepted: No

    Investigator Details

    • Lead Sponsor
      • Duke University
    • Provider of Information About this Clinical Study
      • Sponsor
    • Overall Official(s)
      • Andrew D Krystal, MD, Principal Investigator, Duke University


    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.

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