| April 25, 2007 |
| January 9, 2008 |
| March 2007 |
| December 2009 (final data collection date for primary outcome measure) |
| Response: Effect upon an insomnia severity rating scale at 3 and 6 months. [ Time Frame: 2 weeks, 4 weeks, 3 months ] [ Designated as safety issue: No ] |
| Response: Effect upon an insomnia severity rating scale at 3 and 6 months. |
| Complete list of historical versions of study NCT00465972 on ClinicalTrials.gov Archive Site |
| Response: effect upon cytokine analysis, fatigue, immune measures, and adherence. [ Time Frame: 2 weeks, 4 weeks, 3 months ] [ Designated as safety issue: No ] |
| Response: effect upon cytokine analysis, fatigue, immune measures, and adherence. |
| |
| 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. |
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. |
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. |
| Phase IV |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
|
|
- Drug: Doxepin
- Drug: Temazepam
- Drug: Placebo
|
- Placebo Comparator: Placebo
- Active Comparator: Doxepin
- Active Comparator: Temazepam
|
| 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. |
| |
| Recruiting |
| 60 |
| December 2009 |
| December 2009 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Insomnia
- HIV Seropositive
- Stable HIV Disease
Exclusion Criteria:
- Other psychiatric illnesses
- Unstable HIV disease
|
| Both |
| 18 Years to 69 Years |
| No |
|
|
| United States |
| |
| NCT00465972 |
| Harold Goforth, M.D./Assistant Professor of Psychiatry, Duke University Medical Center |
| 8899 |
| Duke University |
|
| Principal Investigator: |
Harold W Goforth, MD |
Duke University |
|
| Principal Investigator: |
Andrew D Krystal, MD |
Duke University |
|
|
| Duke University |
| January 2008 |
