Patient Preference, Sleep Quality, and Anxiety/Depression: A Comparison of Raltegravir and Efavirenz
NCT ID: NCT00944957
Last Updated: 2010-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2009-11-30
2010-04-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Raltegravir first
Patients treated with Raltegravir for first 2 weeks
Raltegravir for the first 2 weeks
Patient receives raltegravir and efavirenz placebo during the first 2 weeks
Efavirenz for the last 2 weeks
Patient receives efavirenz and raltegravir placebo during the last 2 weeks
Efavirenz first
Patients treated with Efavirenz for first 2 weeks
Efavirenz for the first 2 weeks
Efavirenz and raltegravir placebo for the first 2 weeks
Raltegravir for the last 2 weeks
Raltegravir and efavirenz placebo for the last 2 weeks
Interventions
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Raltegravir for the first 2 weeks
Patient receives raltegravir and efavirenz placebo during the first 2 weeks
Efavirenz for the last 2 weeks
Patient receives efavirenz and raltegravir placebo during the last 2 weeks
Efavirenz for the first 2 weeks
Efavirenz and raltegravir placebo for the first 2 weeks
Raltegravir for the last 2 weeks
Raltegravir and efavirenz placebo for the last 2 weeks
Eligibility Criteria
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Inclusion Criteria
* 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
* 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%
18 Years
ALL
No
Sponsors
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University of Bern
OTHER
University of Lausanne Hospitals
OTHER
Hospital Lugano
UNKNOWN
University Hospital, Basel, Switzerland
OTHER
Hospital of Neuchâtel
UNKNOWN
University Hospital, Zürich
OTHER
University Hospital, Geneva
OTHER
Responsible Party
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Geneva infectious diseases
Principal Investigators
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Bernard BH Hirschel, Professor
Role: PRINCIPAL_INVESTIGATOR
Geneva Hospital
Locations
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University Hopistal of Geneva
Geneva, Canton of Geneva, Switzerland
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Swiss HIV Cohort Study
Other Identifiers
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IEC 09-087
Identifier Type: -
Identifier Source: org_study_id
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