The Treatment of Insomnia in Patients With HIV Disease
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ClinicalTrials.gov Identifier: NCT00465972 |
Recruitment Status
:
Completed
First Posted
: April 27, 2007
Results First Posted
: July 30, 2013
Last Update Posted
: July 30, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections Insomnia | Drug: Doxepin Drug: Temazepam Drug: Placebo | Phase 4 |
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 Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 44 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
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 Start Date : | March 2007 |
Actual Primary Completion Date : | August 2010 |
Actual Study Completion Date : | August 2010 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: Placebo
Placebo
|
Drug: Placebo
Placebo capsule nightly for duration of study
|
Active Comparator: 2
Doxepin
|
Drug: Doxepin
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
|
Active Comparator: 3
Temazepam
|
Drug: Temazepam
Temazepam capsule 15 mg po nightly x duration of study
|
- 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.
- 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.

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Ages Eligible for Study: | 18 Years to 69 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Insomnia
- HIV Seropositive
- Stable HIV Disease
Exclusion Criteria:
- Other psychiatric illnesses
- Unstable HIV disease

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00465972
United States, North Carolina | |
Duke University Medical Center | |
Durham, North Carolina, United States, 27710 |
Principal Investigator: | Andrew D Krystal, MD | Duke University |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Duke University |
ClinicalTrials.gov Identifier: | NCT00465972 History of Changes |
Other Study ID Numbers: |
8899 |
First Posted: | April 27, 2007 Key Record Dates |
Results First Posted: | July 30, 2013 |
Last Update Posted: | July 30, 2013 |
Last Verified: | May 2013 |
Keywords provided by Duke University:
HIV Insomnia Cytokines Adherence |
Additional relevant MeSH terms:
HIV Infections Sleep Initiation and Maintenance Disorders Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Sleep Disorders, Intrinsic Dyssomnias Sleep Wake Disorders Nervous System Diseases Mental Disorders |
Doxepin Temazepam Antidepressive Agents, Tricyclic Antidepressive Agents Psychotropic Drugs Histamine Antagonists Histamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Hypnotics and Sedatives Central Nervous System Depressants Anti-Anxiety Agents Tranquilizing Agents GABA Modulators |