Back to resultsThe Treatment of Insomnia in Patients With HIV Disease
Primary Purpose
HIV Infections, Insomnia
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Doxepin
Temazepam
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring HIV, Insomnia, Cytokines, Adherence
Eligibility Criteria
Inclusion Criteria:
- Insomnia
- HIV Seropositive
- Stable HIV Disease
Exclusion Criteria:
- Other psychiatric illnesses
- Unstable HIV disease
Sites / Locations
- Duke University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Arm Label
Placebo
2
3
Arm Description
Placebo
Doxepin
Temazepam
Outcomes
Primary Outcome Measures
Response: Change in Insomnia Severity Rating Scale at 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
Change in Piper Fatigue Scale at 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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00465972
Brief Title
The Treatment of Insomnia in Patients With HIV Disease
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.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Insomnia
Keywords
HIV, Insomnia, Cytokines, Adherence
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Arm Title
2
Arm Type
Active Comparator
Arm Description
Doxepin
Arm Title
3
Arm Type
Active Comparator
Arm Description
Temazepam
Intervention Type
Drug
Intervention Name(s)
Doxepin
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Temazepam
Intervention Description
Temazepam capsule 15 mg po nightly x duration of study
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo capsule nightly for duration of study
Primary Outcome Measure Information:
Title
Response: Change in Insomnia Severity Rating Scale at 3 Months.
Description
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.
Time Frame
Baseline and 3 months
Secondary Outcome Measure Information:
Title
Change in Piper Fatigue Scale at 3 Months
Description
A 22 item scale measuring level of fatigue, with possible totals ranging from 22-220. A higher number indicates greater severity of fatigue.
Time Frame
Baseline and 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Insomnia
HIV Seropositive
Stable HIV Disease
Exclusion Criteria:
Other psychiatric illnesses
Unstable HIV disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew D Krystal, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
15784792
Citation
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. doi: 10.1097/01.psy.0000151771.46127.df.
Results Reference
background
PubMed Identifier
22131611
Citation
Low Y, Preud'homme X, Goforth HW, Omonuwa T, Krystal AD. The association of fatigue with depression and insomnia in HIV-seropositive patients: a pilot study. Sleep. 2011 Dec 1;34(12):1723-6. doi: 10.5665/sleep.1446.
Results Reference
derived
Learn more about this trial
The Treatment of Insomnia in Patients With HIV Disease
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