Conditions: HIV Infections Insomnia
Keywords: HIV Insomnia Cytokines Adherence
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 44
Healthy volunteers: no

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.

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.

Arms:
arm 1: Placebo arm 2: Doxepin arm 3: Temazepam

Interventions: intervention 1: Doxepin intervention 2: Temazepam intervention 3: Placebo
Intervention descriptions: intervention 1: 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 intervention 2: Temazepam capsule 15 mg po nightly x duration of study intervention 3: Placebo capsule nightly for duration of study

Protocol document: