Efficacy and Safety of Temazepam in HIV Seropositive Patients With Insomnia
Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
The purpose of this study is to test two study drugs, one of which is temazepam (15mg) and
one of which is a placebo (an inactive substance that looks just like the temazepam), to see
if insomnia (trouble sleeping) can be reduced in patients with HIV infection. Placebos are
given in research studies to try and make sure that subjects are responding to the effects of
the study drug and not to other factors, like the attention they are receiving. If you decide
to take part in this study, you will take 1 capsule of study drug every night approximately
30 minutes before bedtime for approximately 12 weeks.
This study is to test the study drug called temazepam for the treatment of insomnia (trouble
sleeping) in patients with HIV infection. Temazepam has been approved by the FDA for the
treatment of insomnia. However, because this study requires treatment for 12 weeks instead of
the 7 to 10 days approved by the FDA, the use of temazepam is considered to be
investigational in this study.