At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 44 enrolled
Drug / intervention
Doxepin +2 moredrug
Likely dose
Doxepin 10 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-blind, Placebo Controlled Study to Assess the Efficacy and Safety of Doxepin and Temazepam in HIV Seropositive Patients With Insomnia.
In Brief
A Phase 4 clinical trial evaluating Doxepin, Temazepam, and 1 other intervention for HIV Infections and Insomnia. Completed, enrolled 44 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections, Insomnia
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMar 2007
First PostedApr 2007
Primary CompletionAug 2010
TodayJul 2026
First PostedApr 27, 2007
Enrollment StartMar 1, 2007
Primary CompletionAug 1, 2010
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 19.2 years ago
Interventions
Doxepindrug
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
Temazepamdrug
Temazepam capsule 15 mg po nightly x duration of study
Placebodrug
Placebo capsule nightly for duration of study