Tenofovir, Emtricitabine and Efavirenz Late Switch to a Single Pill: 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 Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||HIV-positive Patients Under Tenofovir, Emtricitabine and Efavirenz Therapy Switching From a Two-pill Regimen to a Single Pill Regimen: Patients'Opinion Survey|
- Patient adherence [ Time Frame: V0, V1, V2 ] [ Designated as safety issue: No ]by questionnaire in both subgroups and by MEMS data in the adherence subgroup
- Adverse events and symptoms [ Time Frame: V0, V1, V2 ] [ Designated as safety issue: No ]by questionnaires
- Treatment management [ Time Frame: V0, V1, V2 ] [ Designated as safety issue: No ]Treatment management according to meals, timing, disruptive daily schedule By questionnaire
- Patient satisfaction of the switch [ Time Frame: V1, V2 ] [ Designated as safety issue: No ]By questionnaire
- Impact of switch on clinical outcomes [ Time Frame: V0, V1, V2 ] [ Designated as safety issue: No ]Clincal outcomes = viral load, CD4 count, resistance, EFV blood level. By medical file
- Patients' acceptance of switch [ Time Frame: V-1 ] [ Designated as safety issue: No ]
|Study Start Date:||July 2010|
|Study Completion Date:||February 2012|
|Primary Completion Date:||October 2011 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01322932
|Centre Hospitalier Universitaire Vaudois et Policlinique Medicale Universitaire|
|Lausanne, Vaud, Switzerland, 1011|
|Study Chair:||Matthias Cavassini, M.D||Centre Hospitalier Universitaire Vaudois|
|Principal Investigator:||Marie-Paule Schneider, PhD||Policlinique Médicale Universitaire|
|Study Chair:||Olivier Bugnon, Professor||Policlinique Médicale Universitaire|
|Principal Investigator:||Aurélie Gertsch, PhD Student||Policlinique Médicale Universitaire|