HivAES ODEFSEYNCT03451032
Regional Multicenter Study to Evaluate Tolerability and Efficacy of TAF/FTC/RPV Combination (ODEFSEY ®) in Prevention of Sexual or Blood Exposure to HIV
An observational study of Hiv, run by Nantes University Hospital at 6 sites in France.
Trial summary
Prospective, multicenter study to evaluate tolerability, adherence and efficacy of a 28-day course of TAF/FTC/RPV, an HIV post-exposure prophylaxis after a potential sexual or blood exposure to HIV. At baseline, participants are prescribed TAF/FTC/RPV and a blood test. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Hiv
- What is being tested?
- Non Interventional Study
- How many people
- 150 participants
- Where
- 6 sitesFrance
- Study dates
- 15 Mar 2018to 15 Mar 2019
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Persons included in the study are adults who seek care in one of the French CEGIDD or in one of the French centers of " Pays de la Loire " area after a potential sexual or blood HIV exposure with an indication of HIV post-exposure prophylaxis according to the French guidelines.
Who may be able to join
- Subject seeking care in one of the French CEGIDD or in one of the French centers of " Pays de la Loire " area (CHU Nantes, CHU Angers, CHD La Roche sur Yon, CH Le Mans, CH Saint Nazaire, CH Laval) after a potential sexual or non-sexual HIV exposure
- Adult ≥18 years old
- Oral informed consent
- Written informed consent to have their data recorded in an electronic medical record ("Nadis" software).
- Indication of HIV post-exposure prophylaxis according to the French guidelines
Who cannot join
- Subject not willing or refusing to participate
- Subject on legal protection
- HIV positive status
- Pregnancy or breastfeeding
- Already treated by pre exposure prophylaxis
- Already included in the study
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
Angers University Hospital
Angers, 49000
La Roche sur Yon Hospital
La Roche-sur-Yon, 85000
Laval Hospital
Laval, 53000
Le Mans Hospital
Le Mans, 72000
Nantes University Hospital
Nantes, 44093
Saint-Nazaire Hospital
Saint-Nazaire, 44600
About this study
Prospective, multicenter study to evaluate tolerability, adherence and efficacy of a 28-day course of TAF/FTC/RPV, an HIV post-exposure prophylaxis after a potential sexual or blood exposure to HIV.
At baseline, participants are prescribed TAF/FTC/RPV and a blood test. At W6, all participants are contacted by phone to evaluate completeness and tolerability of the TAF/FTC/RPV regimen.
Read the detailed description
At baseline, participants seek care in one of the centers of " Pays de la Loire " area after a potential HIV exposure. They receive TAF/FTC/RPV, one pill taken with food once daily for 28 days according to national guidelines. They have to start this post-exposure prophylaxis within 48 hours after the HIV exposure.
At inclusion, participants give their written consent to have their data recorded in an electronic medical record Nadis® and their oral consent after reading the study information letter. A blood test is prescribed to examine biological variables (HIV, HBV, HCV serologies, TPHA VDRL, ALT/AST, hemogram and serum creatinine). Characteristics of participants and context of the risk are collected in the electronic medical record Nadis®. A blood test is prescribed at W2, W6 and W12 to evaluate tolerability and efficacy of the treatment.
At W6, all participants are contacted by phone call to evaluate completeness and tolerability of the TAF/FTC/RPV regimen. They are reminded to have a blood test done at W6 and W12.
- Conditions
- Hiv
- Being tested
- Non Interventional Study
- Keywords
- HIV exposition treatment, sexual risk, blood risk
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non Interventional StudyOther
Non Interventional Study
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants who stopped the 28-day course of TAF/FTC/RPV
: Phone call to all participants to check on their adherence and to collect information about possible side effects
Measured: At 6 weeks
Secondary outcomes (1)
Proportion of participants who had side effects of the post-exposure prophylaxis with TAF/FTC/RPV
Phone call to all participants to collect information about possible side effects.
Measured: At 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2018
- Study start15 Mar 2018
- Primary completion15 Mar 2019
- Study completion15 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HivStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bénédicte BONNET, Dr, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03451032
- Sponsor's protocol ID
- RC17_0485
- Acronym
- AES ODEFSEY
- Status last verified
- Aug 2019
- First submitted
- 19 Feb 2018
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regional Multicenter Study to Evaluate Tolerability and Efficacy of TAF/FTC/RPV Combination (ODEFSEY ®) in Prevention of Sexual or Blood Exposure to HIV
- ClinicalTrials.gov ID
- NCT03451032
- Acronym / sponsor ID
- AES ODEFSEY / RC17_0485
- Conditions
- Hiv
- Keywords
- HIV exposition treatment, sexual risk, blood risk
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 15 Mar 2018 (actual)
- Primary completion
- 15 Mar 2019 (actual)
- Study completion
- 15 Mar 2019 (actual)
- First posted
- 1 Mar 2018 (actual)
- 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.
Prospective, multicenter study to evaluate tolerability, adherence and efficacy of a 28-day course of TAF/FTC/RPV, an HIV post-exposure prophylaxis after a potential sexual or blood exposure to HIV.
At baseline, participants are prescribed TAF/FTC/RPV and a blood test. At W6, all participants are contacted by phone to evaluate completeness and tolerability of the TAF/FTC/RPV regimen.
Detailed description
At baseline, participants seek care in one of the centers of " Pays de la Loire " area after a potential HIV exposure. They receive TAF/FTC/RPV, one pill taken with food once daily for 28 days according to national guidelines. They have to start this post-exposure prophylaxis within 48 hours after the HIV exposure.
At inclusion, participants give their written consent to have their data recorded in an electronic medical record Nadis® and their oral consent after reading the study information letter. A blood test is prescribed to examine biological variables (HIV, HBV, HCV serologies, TPHA VDRL, ALT/AST, hemogram and serum creatinine). Characteristics of participants and context of the risk are collected in the electronic medical record Nadis®. A blood test is prescribed at W2, W6 and W12 to evaluate tolerability and efficacy of the treatment.
At W6, all participants are contacted by phone call to evaluate completeness and tolerability of the TAF/FTC/RPV regimen. They are reminded to have a blood test done at W6 and W12.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Persons included in the study are adults who seek care in one of the French CEGIDD or in one of the French centers of " Pays de la Loire " area after a potential sexual or blood HIV exposure with an indication of HIV post-exposure prophylaxis according to the French guidelines.
Key inclusion criteria (5 listed)
- Subject seeking care in one of the French CEGIDD or in one of the French centers of " Pays de la Loire " area (CHU Nantes, CHU Angers, CHD La Roche sur Yon, CH Le Mans, CH Saint Nazaire, CH Laval) after a potential sexual or non-sexual HIV exposure
- Adult ≥18 years old
- Oral informed consent
- Written informed consent to have their data recorded in an electronic medical record ("Nadis" software).
- Indication of HIV post-exposure prophylaxis according to the French guidelines
Key exclusion criteria (6 listed)
- Subject not willing or refusing to participate
- Subject on legal protection
- HIV positive status
- Pregnancy or breastfeeding
- Already treated by pre exposure prophylaxis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non Interventional StudyNon Interventional Study | Other | – |
Primary outcome
Proportion of participants who stopped the 28-day course of TAF/FTC/RPV
Time frame: At 6 weeks
: Phone call to all participants to check on their adherence and to collect information about possible side effects
1 secondary outcome
Proportion of participants who had side effects of the post-exposure prophylaxis with TAF/FTC/RPV
Time frame: At 6 weeks
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 28 Aug 2019.
- Individual participant dataSharing planned: No
Related trials for Hiv
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Not yet recruiting
Adapting the ESTEEM Intervention to Improve Mental Health and PrEP Uptake Among Men at Risk of HIV
PrEP Use
RecruitingPhase 2
Evaluating the Safety and Immunogenicity of MTBVAC
HIV I Infection, Tuberculosis
Active, not recruiting
Evaluating the Effectiveness of a Mobile HIV Prevention App to Increase HIV and Sexually Transmitted Infections (STI) Testing and PrEP Initiation Among Rural Men Who Have Sex With Men
HIV Infections, STI
Not yet recruiting
PNF RCT to Decrease Alcohol Use and Increase HIV Prevention
HIV (Human Immunodeficiency Virus), Alcohol Misuse
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.
Bénédicte BONNET, Dr principal investigator
Nantes University Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hiv, run by Nantes University Hospital at 6 sites in France.
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 5 inclusion and 6 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 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. 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?
Proportion of participants who stopped the 28-day course of TAF/FTC/RPV (time frame: At 6 weeks). 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 28 Aug 2019.