Tenofovir, Emtricitabine and Efavirenz Late Switch to a Single Pill: Patients' Opinion Survey

NCT01322932 | Completed

• 1 other identifier: 151/10
• Study Type: observational
• Target: 95
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess adherence, tolerability and satisfaction of each eligible HIV subjects switching from a two- or three-pill tenofovir-emtricitabine-efavirenz (TDF-FTC-EFV) to a one-pill TDF-FTC-EFV treatment.

Conditions

HIV Infection

Keywords

Medication Adherence; HIV Infection; efavirenz, emtricitabine, tenofovir disoproxil fumarate drug combination [Substance Name]; efavirenz; emtricitabine; Patient Satisfaction; tenofovir disoproxil fumarate

Outcome Measures

Primary Outcomes (4)

• Patient adherence

  by questionnaire in both subgroups and by MEMS data in the adherence subgroup

  V0, V1, V2

• Adverse events and symptoms

  by questionnaires

  V0, V1, V2

• Treatment management

  Treatment management according to meals, timing, disruptive daily schedule By questionnaire

  V0, V1, V2

• Patient satisfaction of the switch

  By questionnaire

  V1, V2

Secondary Outcomes (2)

• Impact of switch on clinical outcomes

  V0, V1, V2

• Patients' acceptance of switch

  V-1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients under TDF-FTC-EFV followed up at the Service of Infectious Disease of the University Hospital of Lausanne and enrolled in the Swiss HIV Cohort Study (SHCS) Adherence subgroup: patients enrolled in the HIV adherence program at the pharmacy of the Department of Ambulatory Care \& Community Medicine in Lausanne.

You may qualify if:

• patients under TDF-FTC-EFV
• followed up at the Service of Infectious Disease of the University Hospital of Lausanne
• enrolled in the SHCS

You may not qualify if:

• patients receiving TDF-FTC-EFV in combination with other ARTs
• patients under TDF-FTC-EFV for less than 3 months
• patients not fluent in French

Sponsors & Collaborators

• Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland: lead
• Centre Hospitalier Universitaire Vaudois: collaborator
• Swiss HIV Cohort Study: collaborator
• Gilead Sciences: collaborator

Study Sites (1)

Centre Hospitalier Universitaire Vaudois et Policlinique Medicale Universitaire

Lausanne, Canton of Vaud, 1011, Switzerland

Location

MeSH Terms

Conditions

HIV Infections; Medication Adherence; Patient Satisfaction

Condition Hierarchy (Ancestors)

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; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Matthias Cavassini, M.D

  Centre Hospitalier Universitaire Vaudois

  STUDY CHAIR

• Marie-Paule Schneider, PhD

  Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland

  PRINCIPAL INVESTIGATOR

• Olivier Bugnon, Professor

  Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland

  STUDY CHAIR

• Aurélie Gertsch, PhD Student

  Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pharmacist, PhD

Study Record Dates

• First Submitted: March 24, 2011
• First Posted: March 25, 2011
• Study Start: July 1, 2010
• Primary Completion: October 1, 2011
• Study Completion: February 1, 2012
• Last Updated: December 22, 2015

Record last verified: 2015-12

Locations

CH (1)