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

HIV Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01322932
• Other study ID #: 151/10
• Status: Completed
• Phase: N/A
• First received: March 24, 2011
• Last updated: December 21, 2015
• Start date: July 2010
• Est. completion date: February 2012

Study information

• Verified date: December 2015
• Source: Policlinique Médicale Universitaire
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: February 2012
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• HIV Infection
• HIV Infections

Locations

Country	Name	City	State
Switzerland	Centre Hospitalier Universitaire Vaudois et Policlinique Medicale Universitaire	Lausanne	Vaud

Sponsors (4)

Lead Sponsor	Collaborator
Policlinique Médicale Universitaire	Centre Hospitalier Universitaire Vaudois, Gilead Sciences, Swiss HIV Cohort Study

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient adherence	by questionnaire in both subgroups and by MEMS data in the adherence subgroup	V0, V1, V2	No
Primary	Adverse events and symptoms	by questionnaires	V0, V1, V2	No
Primary	Treatment management	Treatment management according to meals, timing, disruptive daily schedule By questionnaire	V0, V1, V2	No
Primary	Patient satisfaction of the switch	By questionnaire	V1, V2	No
Secondary	Impact of switch on clinical outcomes	Clincal outcomes = viral load, CD4 count, resistance, EFV blood level. By medical file	V0, V1, V2	No
Secondary	Patients' acceptance of switch		V-1	No