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

NCT00944957 | Unknown DMC

• 1 other identifier: IEC 09-087
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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 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

Keywords

Raltegravir; efavirenz; anxiety; depression; sleep quality; HIV; NNRTI; Tritherapy; compliance; stocrin; treatment experienced

Outcome Measures

Primary Outcomes (1)

• Symptoms and neurological side effects of study drugs

  baseline, week 2 and week 4

Secondary Outcomes (4)

• Levels of daytime sleepiness

  baseline, week 2 and week 4

• Sleep Quality

  baseline, week 2 and week 4

• Patient preference

  4 weeks

• Symptoms of depression, anxiety and stress will be assessed

  baseline, week 2 and week 4

Study Arms (2)

Raltegravir first

EXPERIMENTAL

Patients treated with Raltegravir for first 2 weeks

Drug: Raltegravir for the first 2 weeks; Drug: Efavirenz for the last 2 weeks

Efavirenz first

EXPERIMENTAL

Patients treated with Efavirenz for first 2 weeks

Drug: Efavirenz for the first 2 weeks; Drug: Raltegravir for the last 2 weeks

Interventions

Raltegravir for the first 2 weeks DRUG

Patient receives raltegravir and efavirenz placebo during the first 2 weeks

Raltegravir first

Efavirenz for the last 2 weeks DRUG

Patient receives efavirenz and raltegravir placebo during the last 2 weeks

Raltegravir first

Efavirenz for the first 2 weeks DRUG

Efavirenz and raltegravir placebo for the first 2 weeks

Efavirenz first

Raltegravir for the last 2 weeks DRUG

Raltegravir and efavirenz placebo for the last 2 weeks

Efavirenz first

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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%

Sponsors & Collaborators

• University Hospital, Geneva: lead
• University of Bern: collaborator
• University of Lausanne Hospitals: collaborator
• Hospital Lugano: collaborator
• University Hospital, Basel, Switzerland: collaborator
• Hospital of Neuchâtel: collaborator
• University Hospital, Zürich: collaborator

Study Sites (1)

University Hopistal of Geneva

Geneva, Canton of Geneva, 1211, Switzerland

RECRUITING

Related Links

• Swiss HIV Cohort Study
• Homepage Bernard Hirschel

MeSH Terms

Conditions

Sleep Wake Disorders; HIV Infections; Anxiety Disorders; Depression; Sleep Initiation and Maintenance Disorders; Patient Compliance

Interventions

Raltegravir Potassium; efavirenz

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Behavioral Symptoms; Behavior; Sleep Disorders, Intrinsic; Dyssomnias; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior

Intervention Hierarchy (Ancestors)

Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Bernard BH Hirschel, Professor

  Geneva Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bernard BH Hirschel, Professor

CONTACT

022 372 98 11; bernard.hirschel@hcuge.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 21, 2009
• First Posted: July 23, 2009
• Study Start: November 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: April 1, 2010
• Last Updated: January 12, 2010

Record last verified: 2009-07

Locations

CH (1)