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.
1 other identifier
interventional
44
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 hiv-infections
Started Mar 2007
Typical duration for phase_4 hiv-infections
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2007
CompletedFirst Submitted
Initial submission to the registry
April 25, 2007
CompletedFirst Posted
Study publicly available on registry
April 27, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2010
CompletedResults Posted
Study results publicly available
July 30, 2013
CompletedJuly 30, 2013
May 1, 2013
3.4 years
April 25, 2007
December 12, 2012
July 26, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Baseline and 3 months
Secondary Outcomes (1)
Change in Piper Fatigue Scale at 3 Months
Baseline and 3 months
Study Arms (3)
Placebo
PLACEBO COMPARATORPlacebo
2
ACTIVE COMPARATORDoxepin
3
ACTIVE COMPARATORTemazepam
Interventions
Eligibility Criteria
You may qualify if:
- Insomnia
- HIV Seropositive
- Stable HIV Disease
You may not qualify if:
- Other psychiatric illnesses
- Unstable HIV disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duke Universitylead
Study Sites (1)
Duke University Medical Center
Durham, North Carolina, 27710, United States
Related Publications (2)
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.
PMID: 15784792BACKGROUNDLow 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.
PMID: 22131611DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Andrew Krystal, MD, MS, Professor of Psychiatry and Behavioral Sciences
- Organization
- Duke University School of Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
Andrew D Krystal, MD
Duke University
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 25, 2007
First Posted
April 27, 2007
Study Start
March 1, 2007
Primary Completion
August 1, 2010
Study Completion
August 1, 2010
Last Updated
July 30, 2013
Results First Posted
July 30, 2013
Record last verified: 2013-05