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

This study has been completed.
Sponsor:
Collaborators:
Centre Hospitalier Universitaire Vaudois
Swiss HIV Cohort Study
Gilead Sciences
Information provided by (Responsible Party):
Marie Schneider, Policlinique Médicale Universitaire
ClinicalTrials.gov Identifier:
NCT01322932
First received: March 24, 2011
Last updated: May 31, 2012
Last verified: May 2012
History of Changes

March 24, 2011
May 31, 2012
July 2010
October 2011   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01322932 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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.

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.
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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.
HIV Infection
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
95
February 2012
October 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT01322932
151/10
No
Marie Schneider, Policlinique Médicale Universitaire
Policlinique Médicale Universitaire
  • Centre Hospitalier Universitaire Vaudois
  • Swiss HIV Cohort Study
  • Gilead Sciences
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
Policlinique Médicale Universitaire
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP