The Treatment of Insomnia in Patients With HIV Disease
Information source: Duke University
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections; Insomnia
Intervention: Doxepin (Drug); Temazepam (Drug); Placebo (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Duke University Official(s) and/or principal investigator(s):
Harold W Goforth, MD, Principal Investigator, Affiliation: Duke University
Andrew D Krystal, MD, Principal Investigator, Affiliation: Duke University
Overall contact:
Linda Ollis, Phone: 919-681-8789, Email: ollis001@mc.duke.edu
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.
Clinical Details
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 design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: Response: Effect upon an insomnia severity rating scale at 3 and 6 months.
Secondary outcome: Response: effect upon cytokine analysis, fatigue, immune measures, and adherence.
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 69 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Insomnia
- HIV Seropositive
- Stable HIV Disease
Exclusion Criteria:
- Other psychiatric illnesses
- Unstable HIV disease
Locations and Contacts
Linda Ollis, Phone: 919-681-8789, Email: ollis001@mc.duke.edu
Duke University Medical Center, Durham, North Carolina 27710, United States; Recruiting
Harold W Goforth, MC, Phone: 919-681-8742, Email: harold.goforth@duke.edu
Additional Information
Related publications: 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.
Starting date: March 2007
Ending date: December 2009
Last updated: January 9, 2008
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