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

NCT ID: NCT01322932

Last Updated: 2015-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

95 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-07-31

Study Completion Date

2012-02-29

Brief Summary

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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

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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.

Conditions

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HIV Infection

Keywords

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Medication Adherence HIV Infection efavirenz, emtricitabine, tenofovir disoproxil fumarate drug combination [Substance Name] efavirenz emtricitabine Patient Satisfaction tenofovir disoproxil fumarate

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire Vaudois

OTHER

Sponsor Role collaborator

Swiss HIV Cohort Study

NETWORK

Sponsor Role collaborator

Gilead Sciences

INDUSTRY

Sponsor Role collaborator

Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Marie Schneider

Pharmacist, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Matthias Cavassini, M.D

Role: STUDY_CHAIR

Centre Hospitalier Universitaire Vaudois

Marie-Paule Schneider, PhD

Role: PRINCIPAL_INVESTIGATOR

Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland

Olivier Bugnon, Professor

Role: STUDY_CHAIR

Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland

Aurélie Gertsch, PhD Student

Role: PRINCIPAL_INVESTIGATOR

Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland

Locations

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Centre Hospitalier Universitaire Vaudois et Policlinique Medicale Universitaire

Lausanne, Canton of Vaud, Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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151/10

Identifier Type: -

Identifier Source: org_study_id