HIV-1-infectionLAMRESNCT04568239
Impact of M184V on the Virological Efficacy to 3TC/DTG (LAMRES)
An observational study of HIV-1-infection, run by Association de Recherche en Virologie et Dermatologie at 1 site in France.
Trial summary
In view of the prolongation of patients living with HIV's life expectancy, the question of optimization of ART, which is still a life-long treatment, becomes central. While most patients achieve virological success, their treatments often need to be optimized in order to limit adverse events, drugs interactions and to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV-1-infection
- How many people
- 712 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2020to 1 Aug 2022
- 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: HIV-1-infected patients with (i) age ≥18 years, (ii) HIV-RNA ≤50 copies/mL on any ART regimen, (iii) subsequently switching to DTG/3TC, (iv) with at least 1 previous plasma HIV-1 RNA or HIV-DNA genotype, (v) with at least 1 virological and clinical follow-up after switching to DTG/3TC. The occurrence of M184V will be assessed using historical genotypic resistance tests; that is, any detection of this mutation in any previous resistance test will be scored as positive.
Who may be able to join
- HIV-1 infected
- Age ≥ 18 years
- Switched to 3TC/DTG while having HIV-RNA ≤50 copies/mL on any ART regimen
- Followed for at least 1 year after 3TC/DTG switch
- With at least 1 previous genotype
- With at least 1 virological follow-up after switching to 3TC/DTG
Who cannot join
- No genotypic resistance test available before switching to DTG/3TC
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of M184V on the Virological Efficacy to Lamivudine/Dolutegravir
In view of the prolongation of patients living with HIV's life expectancy, the question of optimization of ART, which is still a life-long treatment, becomes central. While most patients achieve virological success, their treatments often need to be optimized in order to limit adverse events, drugs interactions and to improve adherence. The switch to dual regimen strategies represent one of the approaches for treatment optimization. Indeed, dual therapy regimens have shown non-inferior efficacy vs triple therapy as simplification therapy and more recently also as first line therapy. From the real-life data it emerges that today in simplification strategies, the dual regimen therapies are prescribed even in patients with a history of virological failure. Circulating HIV-1 resistant variants can be archived in viral reservoirs, where they can persist for years and can reemerge in case of therapeutic selective pressure. In particular, previous selection of M184V may have an impact on virological response to 3TC/DTG. There are few data on a direct comparison of 3TC/DTG efficacy in patients harboring or not harboring the M184V. So, there is a need to assess the efficacy of 3TC/DTG in patients with past M184V mutation in a large set of patients followed in clinical setting.
Thus, the investigators propose a retrospective study of patients with HIV-RNA ≤50 copies/mL who were switched to 3TC/DTG in order to compare the virological efficacy of 3TC/DTG in patients with and without a history of M184V detection in a previous resistance genotype. This study aimed to analyze 800 patients switched to DTG/3TC in clinical real setting in large European (France, Italy, Spain) database.
- Conditions
- HIV-1-infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| M184V + group and M184 - group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
probability of virological failure
probability of virological failure that is defined as HIV-RNA >50 copies/mL in 2 consecutive determinations or ≥200 copies/mL in a single determination. This outcome will be evaluated overall and between the M184V- and M184V+ patients' groups.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2020
- Study start1 Sep 2020
- Primary completion1 Jun 2022
- Study completion1 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-1-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
- Retrospective
- Enrolment
- 712 participants (actual)
Sponsor and investigators
- Lead sponsor
- Association de Recherche en Virologie et Dermatologie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne-Genevieve Marcelin, PharmD, PhD, Principal investigator, Sorbonne University; APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04568239
- Sponsor's protocol ID
- ARVD-LAMRES
- Acronym
- LAMRES
- Status last verified
- Feb 2023
- First submitted
- 24 Sep 2020
- Last updated
- 10 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of M184V on the Virological Efficacy to Lamivudine/Dolutegravir
- ClinicalTrials.gov ID
- NCT04568239
- Acronym / sponsor ID
- LAMRES / ARVD-LAMRES
- Conditions
- HIV-1-infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 712 participants (actual)
- Lead sponsor
- Association de Recherche en Virologie et DermatologieUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 29 Sep 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.
In view of the prolongation of patients living with HIV's life expectancy, the question of optimization of ART, which is still a life-long treatment, becomes central. While most patients achieve virological success, their treatments often need to be optimized in order to limit adverse events, drugs interactions and to improve adherence. The switch to dual regimen strategies represent one of the approaches for treatment optimization. Indeed, dual therapy regimens have shown non-inferior efficacy vs triple therapy as simplification therapy and more recently also as first line therapy. From the real-life data it emerges that today in simplification strategies, the dual regimen therapies are prescribed even in patients with a history of virological failure. Circulating HIV-1 resistant variants can be archived in viral reservoirs, where they can persist for years and can reemerge in case of therapeutic selective pressure. In particular, previous selection of M184V may have an impact on virological response to 3TC/DTG. There are few data on a direct comparison of 3TC/DTG efficacy in patients harboring or not harboring the M184V. So, there is a need to assess the efficacy of 3TC/DTG in patients with past M184V mutation in a large set of patients followed in clinical setting.
Thus, the investigators propose a retrospective study of patients with HIV-RNA ≤50 copies/mL who were switched to 3TC/DTG in order to compare the virological efficacy of 3TC/DTG in patients with and without a history of M184V detection in a previous resistance genotype. This study aimed to analyze 800 patients switched to DTG/3TC in clinical real setting in large European (France, Italy, Spain) database.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| M184V + group and M184 - group | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HIV-1-infected patients with (i) age ≥18 years, (ii) HIV-RNA ≤50 copies/mL on any ART regimen, (iii) subsequently switching to DTG/3TC, (iv) with at least 1 previous plasma HIV-1 RNA or HIV-DNA genotype, (v) with at least 1 virological and clinical follow-up after switching to DTG/3TC. The occurrence of M184V will be assessed using historical genotypic resistance tests; that is, any detection of this mutation in any previous resistance test will be scored as positive.
Key inclusion criteria (6 listed)
- HIV-1 infected
- Age ≥ 18 years
- Switched to 3TC/DTG while having HIV-RNA ≤50 copies/mL on any ART regimen
- Followed for at least 1 year after 3TC/DTG switch
- With at least 1 previous genotype
Key exclusion criteria (1 listed)
- No genotypic resistance test available before switching to DTG/3TC
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
probability of virological failure
Time frame: 12 months
probability of virological failure that is defined as HIV-RNA >50 copies/mL in 2 consecutive determinations or ≥200 copies/mL in a single determination. This outcome will be evaluated overall and between the M184V- and M184V+ patients' groups.
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 10 Feb 2023.
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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.
Anne-Genevieve Marcelin, PharmD, PhD principal investigator
Sorbonne University; APHP
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-1-infection, run by Association de Recherche en Virologie et Dermatologie at 1 site 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 6 inclusion and 1 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 10 Feb 2023. 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 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?
probability of virological failure (time frame: 12 months). 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 10 Feb 2023.