HIV InfectionsPhase 4NCT04334551
HIV Switch Trial in Experienced Patients With Multiple Class Resistance Including NNRTI Resistance
A Phase 4 study testing Doravirine in people with HIV Infections, run by Clinique du Quartier Latin at 3 sites in 2 countries.
Trial summary
This is a pilot, open, prospective, non-randomized study to evaluate the safety and efficacy of switches from etravirine to doravirine, in experienced patients with multiple class resistance including NNRTI resistance. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- Doravirine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 23 Jun 2020to 1 Oct 2022
- Phase
- Phase 4
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (18 Y.O. or more) women and men infected with HIV.
- Treated with etravirine and at least 2 others ARV in the other classes: NRTI, PI, INSTI, EI, for at least 12 months.
- Virologically controlled (HIV-1 RNA < 50 copies/mL) since at least 6 months. Blips (HIV-ARN ≥ 50 copies/mL, one time, with return to virologic control at the next visit) are allowed.
- Presence of at least one major NNRTI mutation.
- No limitation on the number of previous regimens.
- HCV and HBV-infected patients are allowed
Who cannot join
- High level of resistance to doravirine according to historical resistance tests.
- Level of resistance to doravirine superior to that of etravirine
- Opportunistic or serious active infection or disease
- Active and untreated malignancy.
- Current psychiatric or neurocognitive condition judged by the Investigator to potentially interfere with study visits and procedures
- Pregnancy.
- Active treatment for hepatitis C is forbidden at entry but will be allowed after 3
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Canada2 sites, 2 recruiting
- Not yet recruiting
Clinique Du Quartier Latin
Montreal, Quebec, H2L 4E9
Ioannis vertzagias, 5142853401, ivertzagias@cmql.ca
Benoit Trottier, MD
- Recruiting
Clinique Du Quartier Latin
Montreal, Quebec, H2L 4E9
Ioannis vertzagias, 5142853401, ivertzagias@cmql.ca
Benoit Trottier, MD
Martinique1 site, 1 recruiting
- Not yet recruiting
CHU Martinique
Fort-de-France, Fort de France, CS 90632
André Cabie, 0596 55 23 73, Andre.CABIE@chu-martinique.fr
Lise Cuzin, MD
About this study
Official title: A Pilot, Prospective, Non-randomized Study to Evaluate the Safety and Efficacy of Switches From Etravirine to Doravirine, in Experienced Patients With Multiple Class Resistance Including NNRTI Resistance
This is a pilot, open, prospective, non-randomized study to evaluate the safety and efficacy of switches from etravirine to doravirine, in experienced patients with multiple class resistance including NNRTI resistance. The other ARV medication (protease inhibitor, entry inhibitor and integrase inhibitor) that some patients receive, in addition to the NRTI and NNRTI, will not be changed.
The study will be performed only on two sites
Read the detailed description
The duration of the study will be of 120 weeks: 24 for recruitment and 96 weeks of follow-up. The reasons for the study duration of 2 years is that, up to now, doravirine has not been studied in 2 or 3 classes multi-drug-resistance (MDR) and thus, demonstration of durability of effect over a prolonged period of time is as important as the short-term efficacy.
- Conditions
- HIV Infections
- Being tested
- Doravirine
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DoravirineDrug
switches from etravirine to doravirine, in experienced HIV patients
| Study group | Role | What they receive |
|---|---|---|
| switch from etravirine to doravirine | Experimental | switches to doravirine, Receives: Drug: Doravirine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects who maintain virologic control .
Virologic control is defined by measurement of HIV-1 RNA < 50 copies/mL.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2020
- Study start23 Jun 2020
- Primary completion14 Jul 2022 (estimated)
- Study completion1 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A pilot, prospective, non-randomized study to evaluate the safety and efficacy of switches from etravirine to doravirine, in experienced patients with multiple class resistance including NNRTI resistance
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinique du Quartier Latin
- Sponsor type
- Research network
- Collaborators
- Merck Frosst Canada Ltd.
- Responsible party
- Principal investigator, Benoit Trottier, Clinique du Quartier Latin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04334551
- Sponsor's protocol ID
- Doravirine and HIV VT#59184
- Status last verified
- Jan 2021
- First submitted
- 23 Mar 2020
- Last updated
- 29 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 29 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot, Prospective, Non-randomized Study to Evaluate the Safety and Efficacy of Switches From Etravirine to Doravirine, in Experienced Patients With Multiple Class Resistance Including NNRTI Resistance
- ClinicalTrials.gov ID
- NCT04334551
- Acronym / sponsor ID
- Doravirine and HIV VT#59184
- Conditions
- HIV Infections
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Clinique du Quartier LatinResearch network
- Collaborators
- Merck Frosst Canada Ltd.
- Study start
- 23 Jun 2020 (actual)
- Primary completion
- 14 Jul 2022 (estimated)
- Study completion
- 1 Oct 2022 (estimated)
- First posted
- 6 Apr 2020 (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.
This is a pilot, open, prospective, non-randomized study to evaluate the safety and efficacy of switches from etravirine to doravirine, in experienced patients with multiple class resistance including NNRTI resistance. The other ARV medication (protease inhibitor, entry inhibitor and integrase inhibitor) that some patients receive, in addition to the NRTI and NNRTI, will not be changed.
The study will be performed only on two sites
Detailed description
The duration of the study will be of 120 weeks: 24 for recruitment and 96 weeks of follow-up. The reasons for the study duration of 2 years is that, up to now, doravirine has not been studied in 2 or 3 classes multi-drug-resistance (MDR) and thus, demonstration of durability of effect over a prolonged period of time is as important as the short-term efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A pilot, prospective, non-randomized study to evaluate the safety and efficacy of switches from etravirine to doravirine, in experienced patients with multiple class resistance including NNRTI resistance
| Arm | Type | Receives |
|---|---|---|
| switch from etravirine to doravirine | Experimental | Drug: Doravirineswitches to doravirine, |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult (18 Y.O. or more) women and men infected with HIV.
- Treated with etravirine and at least 2 others ARV in the other classes: NRTI, PI, INSTI, EI, for at least 12 months.
- Virologically controlled (HIV-1 RNA < 50 copies/mL) since at least 6 months. Blips (HIV-ARN ≥ 50 copies/mL, one time, with return to virologic control at the next visit) are allowed.
- Presence of at least one major NNRTI mutation.
- No limitation on the number of previous regimens.
Key exclusion criteria (7 listed)
- High level of resistance to doravirine according to historical resistance tests.
- Level of resistance to doravirine superior to that of etravirine
- Opportunistic or serious active infection or disease
- Active and untreated malignancy.
- Current psychiatric or neurocognitive condition judged by the Investigator to potentially interfere with study visits and procedures
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 |
|---|---|---|
| Doravirineswitches from etravirine to doravirine, in experienced HIV patients | Drug | switch from etravirine to doravirine |
Primary outcome
Percentage of subjects who maintain virologic control .
Time frame: 24 weeks
Virologic control is defined by measurement of HIV-1 RNA < 50 copies/mL.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2021.
- 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.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Doravirine in people with HIV Infections, run by Clinique du Quartier Latin at 3 sites in 2 countries.
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 6 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 29 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada, Martinique. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ioannis vertzagias (5142853401, ivertzagias@cmql.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of subjects who maintain virologic control . (time frame: 24 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 29 Jan 2021.