Clinical trial NCT01322932: Tenofovir, Emtricitabine and Efavirenz Late Switch to a Single Pill: Patients' Opinion Survey
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infection
Keywords: Medication Adherence
HIV Infection
efavirenz, emtricitabine, tenofovir disoproxil fumarate drug combination [Substance Name]
efavirenz
emtricitabine
Patient Satisfaction
tenofovir disoproxil fumarate
Lead sponsor: Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier Universitaire Vaudois
name: Swiss HIV Cohort Study
name: Gilead Sciences
First posted: 2011-03-25
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient adherence
timeFrame: V0, V1, V2
measure: Adverse events and symptoms
timeFrame: V0, V1, V2
measure: Treatment management
timeFrame: V0, V1, V2
measure: Patient satisfaction of the switch
timeFrame: V1, V2
Secondary outcomes:
measure: Impact of switch on clinical outcomes
timeFrame: V0, V1, V2
measure: Patients' acceptance of switch
timeFrame: V-1
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois et Policlinique Medicale Universitaire
state: Vaud
Study officials:
affiliation: Centre Hospitalier Universitaire Vaudois
name: Matthias Cavassini, M.D
role: STUDY_CHAIR
affiliation: Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
name: Marie-Paule Schneider, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
name: Olivier Bugnon, Professor
role: STUDY_CHAIR
affiliation: Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
name: Aurélie Gertsch, PhD Student
role: PRINCIPAL_INVESTIGATOR
References: