Tenofovir, Emtricitabine and Efavirenz Late Switch to a Single Pill: Patients' Opinion Survey
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|ClinicalTrials.gov Identifier: NCT01322932|
Recruitment Status : Completed
First Posted : March 25, 2011
Last Update Posted : December 22, 2015
|Condition or disease|
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|
|Actual Enrollment :||95 participants|
|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|
|Study Start Date :||July 2010|
|Actual Primary Completion Date :||October 2011|
|Actual Study Completion Date :||February 2012|
- Patient adherence [ Time Frame: V0, V1, V2 ]by questionnaire in both subgroups and by MEMS data in the adherence subgroup
- Adverse events and symptoms [ Time Frame: V0, V1, V2 ]by questionnaires
- Treatment management [ Time Frame: V0, V1, V2 ]Treatment management according to meals, timing, disruptive daily schedule By questionnaire
- Patient satisfaction of the switch [ Time Frame: V1, V2 ]By questionnaire
- Impact of switch on clinical outcomes [ Time Frame: V0, V1, V2 ]Clincal outcomes = viral load, CD4 count, resistance, EFV blood level. By medical file
- Patients' acceptance of switch [ Time Frame: V-1 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|