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

NCT00944957 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2010-01-12

No results posted yet for this study

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.

Conditions

  • Sleep Disorders
  • HIV Infections

Interventions

DRUG

Raltegravir for the first 2 weeks

Patient receives raltegravir and efavirenz placebo during the first 2 weeks

DRUG

Efavirenz for the last 2 weeks

Patient receives efavirenz and raltegravir placebo during the last 2 weeks

DRUG

Efavirenz for the first 2 weeks

Efavirenz and raltegravir placebo for the first 2 weeks

DRUG

Raltegravir for the last 2 weeks

Raltegravir and efavirenz placebo for the last 2 weeks

Sponsors & Collaborators

  • University of Bern

    collaborator OTHER

  • University of Lausanne Hospitals

    collaborator OTHER

  • Hospital Lugano

    collaborator UNKNOWN

  • University Hospital, Basel, Switzerland

    collaborator OTHER

  • Hospital of Neuchâtel

    collaborator UNKNOWN

  • University Hospital, Zürich

    collaborator OTHER

  • University Hospital, Geneva

    lead OTHER

Principal Investigators

  • Bernard BH Hirschel, Professor · Geneva Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2009-12-31
Completion
2010-04-30

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00944957 on ClinicalTrials.gov