HIV InfectionNCT01322932
Tenofovir, Emtricitabine and Efavirenz Late Switch to a Single Pill: Patients' Opinion Survey
An observational study of HIV Infection, run by Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infection
- How many people
- 95 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jul 2010to Feb 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- patients under TDF-FTC-EFV
- followed up at the Service of Infectious Disease of the University Hospital of Lausanne
- enrolled in the SHCS
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Centre Hospitalier Universitaire Vaudois et Policlinique Medicale Universitaire
Lausanne, Canton of Vaud, 1011
About this study
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
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.
Read the 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.
- Conditions
- HIV Infection
- Keywords
- Medication Adherence, HIV Infection, efavirenz, emtricitabine, tenofovir disoproxil fumarate drug combination [Substance Name], efavirenz, emtricitabine, Patient Satisfaction, tenofovir disoproxil fumarate
- Medical subject headings
- HIV Infections, Medication Adherence, Patient Satisfaction
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient adherence
by questionnaire in both subgroups and by MEMS data in the adherence subgroup
Measured: V0, V1, V2
Adverse events and symptoms
by questionnaires
Measured: V0, V1, V2
Treatment management
Treatment management according to meals, timing, disruptive daily schedule By questionnaire
Measured: V0, V1, V2
Patient satisfaction of the switch
By questionnaire
Measured: V1, V2
Secondary outcomes (2)
Impact of switch on clinical outcomes
Clincal outcomes = viral load, CD4 count, resistance, EFV blood level. By medical file
Measured: V0, V1, V2
Patients' acceptance of switch
Measured: V-1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2011 (estimated)
- Study startJul 2010
- Primary completionOct 2011
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier Universitaire Vaudois, Swiss HIV Cohort Study, Gilead Sciences
- Responsible party
- Sponsor
- Investigators
- Matthias Cavassini, M.D, Study chair, Centre Hospitalier Universitaire VaudoisMarie-Paule Schneider, PhD, Principal investigator, Center for Primary Care and Public Health (Unisante), University of Lausanne, SwitzerlandOlivier Bugnon, Professor, Study chair, Center for Primary Care and Public Health (Unisante), University of Lausanne, SwitzerlandAurélie Gertsch, PhD Student, Principal investigator, Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01322932
- Sponsor's protocol ID
- 151/10
- Status last verified
- Jul 2026
- First submitted
- 24 Mar 2011
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01322932
- Acronym / sponsor ID
- 151/10
- Conditions
- HIV Infection
- Keywords
- Medication Adherence, HIV Infection, efavirenz, emtricitabine, tenofovir disoproxil fumarate drug combination [Substance Name], efavirenz, emtricitabine, Patient Satisfaction, tenofovir disoproxil fumarate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Center for Primary Care and Public Health (Unisante), University of Lausanne, SwitzerlandUniversity, hospital or other
- Collaborators
- Centre Hospitalier Universitaire Vaudois, Swiss HIV Cohort Study, Gilead Sciences
- Study start
- Jul 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 25 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- patients under TDF-FTC-EFV
- followed up at the Service of Infectious Disease of the University Hospital of Lausanne
- enrolled in the SHCS
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Patient adherence
Time frame: V0, V1, V2
by questionnaire in both subgroups and by MEMS data in the adherence subgroup
Adverse events and symptoms
Time frame: V0, V1, V2
by questionnaires
Treatment management
Time frame: V0, V1, V2
Treatment management according to meals, timing, disruptive daily schedule By questionnaire
Patient satisfaction of the switch
Time frame: V1, V2
By questionnaire
2 secondary outcomes
Impact of switch on clinical outcomes
Time frame: V0, V1, V2
Patients' acceptance of switch
Time frame: V-1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthias Cavassini, M.D study chair
Centre Hospitalier Universitaire Vaudois
Marie-Paule Schneider, PhD principal investigator
Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
Olivier Bugnon, Professor study chair
Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infection, run by Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient adherence (time frame: V0, V1, V2). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.