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

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ClinicalTrials.gov Identifier: NCT01322932
Recruitment Status : Completed
First Posted : March 25, 2011
Last Update Posted : December 22, 2015
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
HIV Infection

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.


Study Design

Study Type : Observational
Actual Enrollment : 95 participants
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
Study Start Date : July 2010
Primary Completion Date : October 2011
Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. Patient adherence [ Time Frame: V0, V1, V2 ]
    by questionnaire in both subgroups and by MEMS data in the adherence subgroup

  2. Adverse events and symptoms [ Time Frame: V0, V1, V2 ]
    by questionnaires

  3. Treatment management [ Time Frame: V0, V1, V2 ]
    Treatment management according to meals, timing, disruptive daily schedule By questionnaire

  4. Patient satisfaction of the switch [ Time Frame: V1, V2 ]
    By questionnaire


Secondary Outcome Measures :
  1. Impact of switch on clinical outcomes [ Time Frame: V0, V1, V2 ]
    Clincal outcomes = viral load, CD4 count, resistance, EFV blood level. By medical file

  2. Patients' acceptance of switch [ Time Frame: V-1 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Marie Schneider, Pharmacist, PhD, Policlinique Médicale Universitaire
ClinicalTrials.gov Identifier: NCT01322932     History of Changes
Other Study ID Numbers: 151/10
First Posted: March 25, 2011    Key Record Dates
Last Update Posted: December 22, 2015
Last Verified: December 2015

Keywords provided by Marie Schneider, 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
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Tenofovir
Emtricitabine
Efavirenz
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP3A Inducers