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

Completed

• Conditions: HIV Infection

• Registration Number: NCT01322932
• Lead Sponsor: Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland

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.

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 Timeline

• Study Start: 2010-07
• Study First Submitted: 2011-03-24
• Study First Submitted QC: 2011-03-24
• Study First Posted: 2011-03-25
• Primary Completion: 2011-10
• Study Completion: 2012-02
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-21
• Last Update Posted: 2015-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 95

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patient adherence	V0, V1, V2	by questionnaire in both subgroups and by MEMS data in the adherence subgroup
Adverse events and symptoms	V0, V1, V2	by questionnaires
Treatment management	V0, V1, V2	Treatment management according to meals, timing, disruptive daily schedule By questionnaire
Patient satisfaction of the switch	V1, V2	By questionnaire

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Centre Hospitalier Universitaire Vaudois et Policlinique Medicale Universitaire; 🇨🇭 Lausanne, Vaud, Switzerland