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

HIV-positive Patients Under Tenofovir, Emtricitabine and Efavirenz Therapy Switching From a Two-pill Regimen to a Single Pill Regimen: Patients'Opinion Survey

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.

Study Overview

• Status: Completed
• Conditions: HIV Infection

Detailed Description

Each eligible patient will be screened from de SHCS database. Each refusal and drop-out will be documented. A pre-visit (V-1) will be scheduled for informed consent, V0 for inclusion (V-1 and V0 may occur on the same day), V1 one month post-inclusion and V2 4 to 7 months post-inclusion. V0, V1 and V2 will be planned during regular medical visits.

Eligible patients either get their cART in their usual pharmacy according to standard of care, or take part in a routine adherence-enhancing program(adherence subgroup)run by the pharmacists of the outpatient medical clinic.

In the adherence subgroup, adherence is assessed electronically by MEMS (Medication event monitoring system) monitors on a regular basis.

• Study Type: Observational
• Enrollment (Actual): 95

Contacts and Locations

Study Locations

• Switzerland
  • Vaud
    • Lausanne, Vaud, Switzerland, 1011
      • Centre Hospitalier Universitaire Vaudois et Policlinique Medicale Universitaire

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Impact of switch on clinical outcomes	Clincal outcomes = viral load, CD4 count, resistance, EFV blood level. By medical file	V0, V1, V2
Patients' acceptance of switch		V-1

Collaborators and Investigators

• Sponsor: Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
• Collaborators: Gilead Sciences; Centre Hospitalier Universitaire Vaudois; Swiss HIV Cohort Study
• Investigators: Study Chair: Olivier Bugnon, Professor, Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland; Principal Investigator: Marie-Paule Schneider, PhD, Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland; Study Chair: Matthias Cavassini, M.D, Centre Hospitalier Universitaire Vaudois; Principal Investigator: Aurélie Gertsch, PhD Student, Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): February 1, 2012

Study Registration Dates

• First Submitted: March 24, 2011
• First Submitted That Met QC Criteria: March 24, 2011
• First Posted (Estimate): March 25, 2011

Study Record Updates

• Last Update Posted (Estimate): December 22, 2015
• Last Update Submitted That Met QC Criteria: December 21, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: HIV Infection; tenofovir disoproxil fumarate; efavirenz; Medication Adherence; Patient Satisfaction; emtricitabine; efavirenz, emtricitabine, tenofovir disoproxil fumarate drug combination [Substance Name]
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections
• Other Study ID Numbers: 151/10