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
  Purpose

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.


Condition
HIV Infection

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Policlinique Médicale Universitaire:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 ]

Enrollment: 95
Study Start Date: July 2010
Study Completion Date: February 2012
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01322932

Locations
Switzerland
Centre Hospitalier Universitaire Vaudois et Policlinique Medicale Universitaire
Lausanne, Vaud, Switzerland, 1011
Sponsors and Collaborators
Policlinique Médicale Universitaire
Centre Hospitalier Universitaire Vaudois
Swiss HIV Cohort Study
Gilead Sciences
Investigators
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
  More Information

No publications provided

Responsible Party: Marie Schneider, Pharmacist, PhD, Policlinique Médicale Universitaire
ClinicalTrials.gov Identifier: NCT01322932     History of Changes
Other Study ID Numbers: 151/10
Study First Received: March 24, 2011
Last Updated: May 31, 2012
Health Authority: Switzerland: Ethikkommission

Keywords provided by Policlinique Médicale Universitaire:
Medication Adherence
HIV Infection
efavirenz, emtricitabine, tenofovir disoproxil fumarate drug combination [Substance Name]
efavirenz
emtricitabine
Patient Satisfaction
tenofovir disoproxil fumarate

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Tenofovir
Tenofovir disoproxil
Efavirenz
Efavirenz, emtricitabine, tenofovir disoproxil fumarate drug combination
Emtricitabine
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on August 28, 2014