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Completed

NCT Number: NCT00465972

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.

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Dyssomnias Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Insomnia Lentivirus Infections Mental Disorders Nervous System Diseases RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders Urogenital Diseases Virus Diseases

Age range

18 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Insomnia
  • HIV Seropositive
  • Stable HIV Disease

Exclusion criteria

  • Other psychiatric illnesses
  • Unstable HIV disease

Treatment and study plan

Doxepin

Drug

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

Temazepam

Drug

Temazepam capsule 15 mg po nightly x duration of study

Placebo

Drug

Placebo capsule nightly for duration of study

Primary outcomes

  1. 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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Apr 27, 2007
Registry last updated
Jul 30, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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