Efficacy and Safety of Temazepam in HIV Seropositive Patients With Insomnia
Condition: Insomnia
MeSH terms: HIV Seropositivity; Sleep Initiation and Maintenance Disorders
Intervention: Temazepam; Placebo
Intervention description: Temazepam 15 mg orally at bedtime
Intervention MeSH terms: Temazepam
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 44.0
Sex: All
Minimum age: 18 Years
Maximum age: 69 Years
Healthy volunteers: No
Keywords: Insomnia; HIV

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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. males or females age 18-69;

          2. females must utilize an approved form of birth control during the study;

          3. have at least a 3 month history of insomnia as defined in the DSM-IV criteria for
             primary insomnia;

          4. self report > 60 minutes of wakefulness after initial sleep onset on at least 4 nights
             of 7 consecutive nights;

          5. self report > 30 minutes of self-reported latency to sleep onset on at least 4 nights
             of 7 consecutive nights;

          6. Self report < 6.5 hours of total sleep time at least 4 nights of 7 consecutive nights;

          7. be able to read, understand, and sign an informed consent form before entering into
             the study and must be willing to comply with all study procedures;

          8. agree to participate for the entire study period (a total of approximately 6 months);
             and

          9. provide documentation of HIV seropositivity and be enrolled in ongoing care for their
             HIV disease in an infectious disease clinic with their last examination not exceeding
             3 months prior to screening date

        Exclusion Criteria:

          1. Have a clinically significant unstable medical abnormality, or history or presence of
             significant neurological disorders (including cognitive disorders), or frequent
             nightly urination, defined as > 2 times per night;

          2. Had a clinically significant illness, as determined by the Investigator, within 30
             days of Initial Screening (Visit 1);

          3. Have any clinically significant abnormal finding in physical examination, neurological
             assessment, or vital signs, as determined by the Investigator;

          4. Have a known or exaggerated pharmacological sensitivity or hypersensitivity or
             intolerance to doxepin HCl, any tricyclic antidepressant or antihistamine, temazepam
             or any benzodiazepine;

          5. Have a positive urine drug screen for amphetamines, benzodiazepines, barbiturates,
             cocaine, opiates, or cannabinoids at Initial Screening (Visit 1);

          6. Self reports typical consumption of more than five alcoholic beverages on a single day
             or greater than 14 alcoholic beverages weekly;

          7. Have a history of epilepsy or serious head injury;

          8. Have been on current HAART or antiretroviral regimen for less than 1 month;

          9. Have a recent history (within one year) of alcohol or drug abuse, or current evidence
             of substance dependence or abuse as defined by DSM-IV-TR criteria;

         10. Have used temazepam for any indication within the 30 days prior to Initial Screening
             (Visit 1);

         11. Have used any investigational drug within 30 days or five half-lives (whichever is
             longer) prior to Initial Screening (Visit 1), or plans to use an investigational drug
             (other than the study drug) during the study;

         12. Current use of any of the following medications: antipsychotics, appetite
             suppressants, systemic corticosteroids, theophylline, respiratory stimulants and
             decongestants;

         13. The following medications may be discontinued for the purpose of entry into the study
             provided the medication is taken at bedtime for the indication of sleep. If the
             indication is other than sleep, the medication cannot be discontinued for the purpose
             of entry into the study: anxiolytics, antidepressants, anticonvulsants, histamine-1
             receptor antagonists (except for loratadine, desloratidine, and fexofenadine),
             narcotic analgesics, sedative/hypnotics (other than study drug) or OTC sleep aids;

         14. Have symptoms consistent with the diagnosis of any other sleep disorder other than
             primary insomnia (e.g., sleep apnea, narcolepsy, periodic leg movements, restless leg
             syndrome, etc.);

         15. Have a body mass index (BMI) greater than or equal to 34;

         16. Have insomnia associated with circadian rhythm disturbances, such as night or rotating
             shift work or travel across more than four time zones in the 14 days before Initial
             Screening (Visit 1) or during the study;

         17. Self reports intentional napping more than two times per week;

         18. Have a variation in bedtime of more than three hours on five of seven consecutive
             nights as recorded on the sleep diary;

         19. Have a history of non-adherence to treatment or clinical visit attendance; or,

         20. subjects taking any benzodiazepine within 5 half-lives prior to the study baseline