NCT00792584

Brief 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 twelve week, randomized, placebo-controlled, double-blind study. In group 1, efavirenz will be replaced with efavirenz placebo plus etravirine, in group 2, efavirenz would be continued, and etravirine placebo given in addition. After six 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2008

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

November 17, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 18, 2008

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

September 12, 2011

Status Verified

September 1, 2011

Enrollment Period

Same day

First QC Date

November 17, 2008

Last Update Submit

September 9, 2011

Conditions

Sleep Disorders

Keywords

etravirineefavirenzanxietydepressionsleep qualityHIVNNRTITritherapycompliancestocrinTo replace efavirenz in long-term users with etravirineTo investigate effect of such replacement on patient preference, sleep quality, daytime sleepiness, and anxiety

Outcome Measures

Primary Outcomes (1)

  • Symptoms and neurological side effects of study drugs

    baseline, week 6 and week 12

Secondary Outcomes (4)

  • Levels of daytime sleepiness

    baseline, week 6 and week 12

  • Sleep Quality

    baseline, week 6 and week 12

  • Patient preference

    12 weeks

  • Symptoms of depression, anxiety and stress will be assessed

    baseline, week 6 and week 12

Study Arms (2)

1

EXPERIMENTAL

patients treats with etravirine for 6 weeks

Drug: etravirine

2

EXPERIMENTAL

patients treats with efavirenz for 6 weeks

Drug: efavirenz

Interventions

etravirineDRUG

Patient receives etravirine/ placebo or efavirenz / placebo

1
efavirenzDRUG

patient receives efavirenz / placebo or etravirine / placebo

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Geneva Hospital

Geneva, Canton of Geneva, 1211, Switzerland

Location

Related Links

MeSH Terms

Conditions

Sleep Wake DisordersAnxiety DisordersDepressionSleep Initiation and Maintenance DisordersPatient ComplianceDisorders of Excessive Somnolence

Interventions

etravirineefavirenz

Condition Hierarchy (Ancestors)

Nervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersBehavioral SymptomsBehaviorSleep Disorders, IntrinsicDyssomniasPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth Behavior

Study Officials

  • Bernard BH Hirschel, Professor

    Geneva Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

November 17, 2008

First Posted

November 18, 2008

Study Start

November 1, 2008

Primary Completion

November 1, 2008

Study Completion

June 1, 2009

Last Updated

September 12, 2011

Record last verified: 2011-09

Locations

CH(1)