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Patient Preference, Sleep Quality, and Anxiety/Depression: A Comparison of Raltegravir and Efavirenz

Information source: University Hospital, Geneva
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Sleep Disorders; HIV Infections

Intervention: Raltegravir for the first 2 weeks (Drug); Efavirenz for the last 2 weeks (Drug); Efavirenz for the first 2 weeks (Drug); Raltegravir for the last 2 weeks (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: University Hospital, Geneva

Official(s) and/or principal investigator(s):
Bernard BH Hirschel, Professor, Principal Investigator, Affiliation: Geneva Hospital

Overall contact:
Bernard BH Hirschel, Professor, Phone: 022 372 98 11, Ext: +41, Email: bernard.hirschel@hcuge.ch

Summary

Efavirenz causes neuropsychiatric side effects and sleep disturbance, including vivid dreams, dizziness, and abnormal tiredness. These symptoms are frequent during the first weeks of treatment, with subsequent attenuation but may not completely resolve even years after efavirenz initiation. The investigators plan a four week, randomized, placebo-controlled, double-blind study. In group 1, efavirenz will be replaced with efavirenz placebo plus raltegravir, in group 2, efavirenz would be continued, and raltegravir placebo given in addition. After two weeks, patients in group 1 would switch to the regimen of group 2, and vice versa. The primary endpoint of the trial will be patient preference. Sleep quality, daytime sleepiness, and anxiety will also be investigated.

Clinical Details

Official title: Patient Preference, Sleep Quality, and Anxiety/Depression: Comparison of Raltegravir and Efavirenz

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Symptoms and neurological side effects of study drugs

Secondary outcome:

Levels of daytime sleepiness

Sleep Quality

Patient preference

Symptoms of depression, anxiety and stress will be assessed

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Adult patients > 18 years

- Signing the study consent form and agree to change ART regimen

- Stable HAART including EFV since at least 3 months

- HIV-RNA below 50 copies for at least 3 months

Exclusion Criteria:

- No major psychiatric disease (psychosis, severe depression) diagnosed before the

initiation of EFV

- Mentally incompetent patients

- Pregnancy or lactation Women of childbearing potential must use one or two reliable

contraceptive methods during the trial, from day 1 to the end of week 12. Acceptable methods include the birth control pill, IUD, condoms with spermicides. Non-acceptable methods include (non-exhaustive list): Withdrawal, calendar (Onigo method), or spermicides alone.

- Concomitant renal or hepatic disease:

- Creatinine above 150 micromol/L

- Transaminases above 5 times upper normal limit

- Prothrombin (Quick) value below 50%

Locations and Contacts

Bernard BH Hirschel, Professor, Phone: 022 372 98 11, Ext: +41, Email: bernard.hirschel@hcuge.ch

University Hopistal of Geneva, Geneva 1211, Switzerland; Recruiting
Bernard BH Hirschel, Professor, Phone: 022 372 98 11, Ext: +41, Email: bernard.hirschel@hcuge.ch
Additional Information

Swiss HIV Cohort Study

Homepage Bernard Hirschel

Starting date: November 2009
Last updated: January 11, 2010

Page last updated: August 23, 2015

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