Tenofovir, Emtricitabine and Efavirenz Late Switch to a Single Pill: Patients' Opinion Survey
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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 |
- 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
- 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) |
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 |
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.
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| Switzerland | |
| Centre Hospitalier Universitaire Vaudois et Policlinique Medicale Universitaire | |
| Lausanne, Vaud, Switzerland, 1011 | |
| 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 May 22, 2013