HIV RiskPhase 3NCT02998320
Evaluation of Compliance With Treatment by Genvoya in HIV Post-exposure Prophylaxis
A Phase 3 study testing Genvoya in people with HIV Risk, run by Groupe d'Etude sur le Risque d'Exposition des Soignants aux Agents Infectieux at 16 sites in France.
Trial summary
This study measures the proportion of enrolled patients taking the uninterrupted HIV post-exposure prophylaxis Genvoya for four weeks Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Risk
- What is being tested?
- Genvoya
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 16 sitesFrance
- Study dates
- 10 Mar 2017to 30 Sep 2018
- Phase
- Phase 3
- 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
Who may be able to join
- an age above 18 years
- consultation within 48 hours following a risk of HIV transmission (blood or sexual contact)
- indication for HIV post-exposure prophylaxis (according to French guidelines)
- person able to understand the nature of the study
- person who signed his consent form to participate in the study
Who cannot join
- person exposed to HIV risk from person infected by HIV, whose therapeutic history justifies the prescription of another combination of antiretroviral drugs
- contraindications to the prescription of Genvoy
- other medical contraindications
- person infected by hepatitis B virus
- pregnant or lactating woman
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
France16 sites
Hôpital Jean Minjoz
Besançon, 25030
Hôpital Saint-André
Bordeaux, 33075
CHU Ambroise Paré
Boulogne-Billancourt, 92100
Hôpital Manchester
Charleville-Mézières, 08011
CHU Dijon
Dijon, 77908
Hôpital Croix Rousse
Lyon, 69317
CHR de Metz
Metz, 57050
CHU Bichat
Paris, 75018
Hôpital Tenon
Paris, 75020
Hôpital Saint-Antoine
Paris, 75571
GH Pitié Salpetriere
Paris, 75651
CHU de Reims
Reims, 51092
CHU
Rennes, 35033
Hôpitaux Universitaires
Strasbourg, 67091
Hôpital Foch
Suresnes, 92150
Hôpital de Tourcoing
Tourcoing, 59208
About this study
Official title: Evaluation of Compliance With Treatment by Elvitegravir/Cobicistat/FTC/Tenofovir Alafenamide (E/C/F/TAF) in HIV Post-exposure Prophylaxis (to Infected Blood or Sexual Contact)
This study measures the proportion of enrolled patients taking the uninterrupted HIV post-exposure prophylaxis Genvoya for four weeks
Read the detailed description
This study measures the proportion of enrolled patients taking the uninterrupted HIV post-exposure prophylaxis Elvitegravir/Cobicistat/FTC/Tenofovir alafenamide (E/C/F/TAF) for four Weeks.
Elvitegravir is an HIV-1 integrase strand transfer inhibitor (INSTI). Cobicistat is a selective, mechanism-based inhibitor of cytochrome P450 (CYP) enzymes of the CYP3A subfamily. Emtricitabine is a nucleoside reverse transcriptase inhibitor (NRTI) and nucleoside analogue àf 2'-dexicytidine. Tenofovir alafenamide is a nucleotide reverse transcriptase inhibitor (NtRTI) and phosphonoamidate prodrug of tenofovir (2'-deoxyadenosine monophosphate analogue).
- Conditions
- HIV Risk
- Being tested
- Genvoya
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GenvoyaDrug
Also called (E/C/F/TAF) ATC Code: J05AR18
Oral use (one tablet each day); 150/150/200/10 mg; 28 days
| Study group | Role | What they receive |
|---|---|---|
| Genvoya | Experimental | Genvoya (E/C/F/TAF) Tablet (oral use) : 150/150/200/10 mg, one tablet each day for 28 days Receives: Drug: Genvoya |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients taking the uninterrupted HIV post-exposure prophylaxis for four weeks
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2016 (estimated)
- Study start10 Mar 2017
- Primary completion30 Jun 2018
- Study completion30 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV RiskStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe d'Etude sur le Risque d'Exposition des Soignants aux Agents Infectieux
- Sponsor type
- Research network
- Collaborators
- Gilead Sciences
- Responsible party
- Sponsor
- Investigators
- David Rey, Principal investigator, Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02998320
- Sponsor's protocol ID
- GEFR1044015
- Status last verified
- Feb 2019
- First submitted
- 14 Dec 2016
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gantner P, Hessamfar M, Souala MF, Valin N, Simon A, Ajana F, Bouvet E, Rouveix E, Cotte L, Bani-Sadr F, Hustache-Mathieu L, Lebrette MG, Truchetet F, Galempoix JM, Piroth L, Pellissier G, Muret P, Rey D; E/C/F/TAF PEP Study Group. Elvitegravir-Cobicistat-Emtricitabine-Tenofovir Alafenamide Single-tablet Regimen for Human Immunodeficiency Virus Postexposure Prophylaxis. Clin Infect Dis. 2020 Feb 14;70(5):943-946. doi: 10.1093/cid/ciz577.
PubMed 31804669
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Compliance With Treatment by Elvitegravir/Cobicistat/FTC/Tenofovir Alafenamide (E/C/F/TAF) in HIV Post-exposure Prophylaxis (to Infected Blood or Sexual Contact)
- ClinicalTrials.gov ID
- NCT02998320
- Acronym / sponsor ID
- GEFR1044015
- Conditions
- HIV Risk
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Groupe d'Etude sur le Risque d'Exposition des Soignants aux Agents InfectieuxResearch network
- Collaborators
- Gilead Sciences
- Study start
- 10 Mar 2017 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 20 Dec 2016 (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.
This study measures the proportion of enrolled patients taking the uninterrupted HIV post-exposure prophylaxis Genvoya for four weeks
Detailed description
This study measures the proportion of enrolled patients taking the uninterrupted HIV post-exposure prophylaxis Elvitegravir/Cobicistat/FTC/Tenofovir alafenamide (E/C/F/TAF) for four Weeks.
Elvitegravir is an HIV-1 integrase strand transfer inhibitor (INSTI). Cobicistat is a selective, mechanism-based inhibitor of cytochrome P450 (CYP) enzymes of the CYP3A subfamily. Emtricitabine is a nucleoside reverse transcriptase inhibitor (NRTI) and nucleoside analogue àf 2'-dexicytidine. Tenofovir alafenamide is a nucleotide reverse transcriptase inhibitor (NtRTI) and phosphonoamidate prodrug of tenofovir (2'-deoxyadenosine monophosphate analogue).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Genvoya | Experimental | Drug: GenvoyaGenvoya (E/C/F/TAF) Tablet (oral use) : 150/150/200/10 mg, one tablet each day for 28 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- an age above 18 years
- consultation within 48 hours following a risk of HIV transmission (blood or sexual contact)
- indication for HIV post-exposure prophylaxis (according to French guidelines)
- person able to understand the nature of the study
- person who signed his consent form to participate in the study
Key exclusion criteria (5 listed)
- person exposed to HIV risk from person infected by HIV, whose therapeutic history justifies the prescription of another combination of antiretroviral drugs
- contraindications to the prescription of Genvoy
- other medical contraindications
- person infected by hepatitis B virus
- pregnant or lactating woman
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 |
|---|---|---|
| GenvoyaAlso: (E/C/F/TAF) ATC Code: J05AR18Oral use (one tablet each day); 150/150/200/10 mg; 28 days | Drug | Genvoya |
Primary outcome
Proportion of patients taking the uninterrupted HIV post-exposure prophylaxis for four weeks
Time frame: Day 28
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 15 Feb 2019.
- Derived from this study: PubMed 31804669Gantner P, Hessamfar M, Souala MF, Valin N, Simon A, Ajana F, Bouvet E, Rouveix E, Cotte L, Bani-Sadr F, Hustache-Mathieu L, Lebrette MG, Truchetet F, Galempoix JM, Piroth L, Pellissier G, Muret P, Rey D; E/C/F/TAF PEP Study Group. Elvitegravir-Cobicistat-Emtricitabine-Tenofovir Alafenamide Single-tablet Regimen for Human Immunodeficiency Virus Postexposure Prophylaxis. Clin Infect Dis. 2020 Feb 14;70(5):943-946. doi: 10.1093/cid/ciz577.
- Individual participant dataSharing planned: No
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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.
David Rey principal investigator
Hôpitaux Universitaires de Strasbourg
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Genvoya in people with HIV Risk, run by Groupe d'Etude sur le Risque d'Exposition des Soignants aux Agents Infectieux at 16 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 5 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 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 patients taking the uninterrupted HIV post-exposure prophylaxis for four weeks (time frame: Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02998320, which also lists 1 linked publication.
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 15 Feb 2019.