HIV Infection
Conditions
Keywords
Medication Adherence, HIV Infection, efavirenz, emtricitabine, tenofovir disoproxil fumarate drug combination [Substance Name], efavirenz, emtricitabine, Patient Satisfaction, tenofovir disoproxil fumarate
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.
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.
Interventions
None listed
Sponsors
Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
Centre Hospitalier Universitaire Vaudois
Swiss HIV Cohort Study
Gilead Sciences
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient adherence | V0, V1, V2 | by questionnaire in both subgroups and by MEMS data in the adherence subgroup |
| Adverse events and symptoms | V0, V1, V2 | by questionnaires |
| Treatment management | V0, V1, V2 | Treatment management according to meals, timing, disruptive daily schedule By questionnaire |
| Patient satisfaction of the switch | V1, V2 | By questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Impact of switch on clinical outcomes | V0, V1, V2 | Clincal outcomes = viral load, CD4 count, resistance, EFV blood level. By medical file |
| Patients' acceptance of switch | V-1 | — |
Countries
Switzerland
Contacts
STUDY_CHAIRMatthias Cavassini, M.D
Centre Hospitalier Universitaire Vaudois
PRINCIPAL_INVESTIGATORMarie-Paule Schneider, PhD
Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
STUDY_CHAIROlivier Bugnon, Professor
Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
PRINCIPAL_INVESTIGATORAurélie Gertsch, PhD Student
Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
Outcome results
None listed