The Treatment of Insomnia in Patients With HIV Disease

Phase 4

Completed

• Conditions: HIV Infections; Insomnia
• Interventions: Drug: Placebo; Drug: Doxepin; Drug: Temazepam

• Registration Number: NCT00465972
• Lead Sponsor: Duke University

Brief Summary

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.

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.

Study Timeline

• Study Start: 2007-03
• Study First Submitted: 2007-04-25
• Study First Submitted QC: 2007-04-25
• Study First Posted: 2007-04-27
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Results First Submitted: 2012-12-12
• Status Verified: 2013-05
• Results First Submitted QC: 2013-07-26
• Last Update Submitted: 2013-07-26
• Results First Posted: 2013-07-30
• Last Update Posted: 2013-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• Insomnia
• HIV Seropositive
• Stable HIV Disease

Exclusion Criteria

• Other psychiatric illnesses
• Unstable HIV disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo
2	Doxepin	Doxepin
3	Temazepam	Temazepam

Primary Outcome Measures

Name	Time	Method
Response: Change in Insomnia Severity Rating Scale at 3 Months.	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 Outcome Measures

Name	Time	Method
Change in Piper Fatigue Scale at 3 Months	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.

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States