HIVROSETTANCT06706986
A Global Registry On Second gEneration and Long-acting inTegrase inhibiTor fAilures
An observational study of HIV and Therapy Failure, run by UMC Utrecht at 1 site in Netherlands.
Trial summary
Integrase strand transfer inhibitors (INSTI) inhibit HIV replication by preventing the integration of viral HIV DNA into the host's genome. INSTIs are used as part of combination antiretroviral therapy (cART) regimens for both treatment-naive and treatment experienced patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- HIV, Therapy Failure
- How many people
- 250 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Sep 2023to 1 Sep 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: People living with HIV-1 experiencing virological failure to second-generation integrase inhibitors from Africa, Americas and Europe.
Who may be able to join
- Confirmed HIV-1 infection
- Using cART (any regimen) for at least the last 6 months
- Experiencing virological failure* on a second generation INSTI-containing regimen (including monotherapy and dual-therapy regimens)
- Data on current regimen and previous INSTI exposure available (start/stop dates and dosing mandatory)
- Integrase genotypic data available (performed locally) or a plasma/DBS (or CSF if available) sample(s) drawn at time of failure available to perform genotypic testing centrally * Virological failure is defined as at least 2 consecutive viral loads (VL) above 50 copies/mL in plasma or 1 VL above 200 copies/mL in plasma. We will also include patients who have a VL of >50 copies/mL in CSF, independent of the VL in plasma.
Who cannot join
- Submitted fasta file not passing quality control and unavailability of a stored sample to repeat sequence analysis
- Missing Mandatory data
- Documented treatment interruption for at least 2 weeks prior to viral load testing.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: ROSETTA- A Global Registry On Second gEneration and Long-acting inTegrase inhibiTor fAilures
Integrase strand transfer inhibitors (INSTI) inhibit HIV replication by preventing the integration of viral HIV DNA into the host's genome. INSTIs are used as part of combination antiretroviral therapy (cART) regimens for both treatment-naive and treatment experienced patients.
In clinical practice, virological failure to second generation INSTIs is rare and often without selection of known resistance mutations. Considering the use of INSTIs in first line regimens in high income countries and the increasing roll-out in lower and middle income countries, a better understanding of relevant resistance development and clinical failure is urgently needed.
Read more
The ROSETTA registry aims at systematically collecting otherwise scattered information on individual cases failing second generation integrase inhibitors, with the goal to inform policy and future use of INSTIs in the treatment of people living with HIV.
Attending physicians of individuals who are experiencing virological failure on a second generation integrase inhibitor-containing regimen are invited to contribute data to the registry.
Read the detailed description
The ROSETTA study collects clinical data and HIV sequences from individuals experiencing failure of ART containing second generation INSTIs from Americas, Africa and Europe. If resistance testing is not available, the ROSETTA team can perform genotypic resistance testing of RT, protease, integrase and 3'-PPT.
Research objectives:
To set up a database with data of individuals who have experienced virological failure on a regimen containing a second generation INSTI To determine the prevalence of resistance mutations in integrase and 3'-PPT in the dataset To identify possible new resistance mutations outside integrase and 3'-PPT. providing additional funding is retrieved.
The study design will be a multicenter observational cohort study. Patients will be included from HIV care centers in Europe, America and Africa, if they fullfill the inclusion criteria.
- Conditions
- HIV, Therapy Failure
- Keywords
- integrase inhibitors, HIV drug resistance, subtype
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence and patterns of resistance in the dataset
The prevalence of resistance in the dataset in relation to HIV subtype and collected clinical parameters
Measured: 3 years
Secondary outcomes (1)
Identify new mutations related to integrase inhibitor resistance
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2024
- Study start1 Sep 2023
- Primary completion1 Sep 2024
- Study completion1 Sep 2025 (estimated)
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 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
- Other
- Time perspective
- Other
- Enrolment
- 250 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Collaborators
- Luxembourg Institute of Health, Erasmus Medical Center
- Responsible party
- Principal investigator, Dr. Annemarie Wensing, UMC Utrecht
- Investigators
- Annemarie MJ Wensing, MD,PhD, Principal investigator, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06706986
- Sponsor's protocol ID
- V0002187
- Acronym
- ROSETTA
- Status last verified
- Nov 2024
- First submitted
- 22 Nov 2024
- Last updated
- 27 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: ROSETTA will not own the data
Publications
Special Issue: Abstract Supplement HIV Glasgow 10-13 November 2024, Glasgow, UK/Virtual. J Int AIDS Soc. 2024 Nov;27 Suppl 6(Suppl 6):e26370. doi: 10.1002/jia2.26370. No abstract available.
PubMed 39513741
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ROSETTA- A Global Registry On Second gEneration and Long-acting inTegrase inhibiTor fAilures
- ClinicalTrials.gov ID
- NCT06706986
- Acronym / sponsor ID
- ROSETTA / V0002187
- Conditions
- HIV, Therapy Failure
- Keywords
- integrase inhibitors, HIV drug resistance, subtype
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Collaborators
- Luxembourg Institute of Health, Erasmus Medical Center
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 27 Nov 2024 (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.
Integrase strand transfer inhibitors (INSTI) inhibit HIV replication by preventing the integration of viral HIV DNA into the host's genome. INSTIs are used as part of combination antiretroviral therapy (cART) regimens for both treatment-naive and treatment experienced patients.
In clinical practice, virological failure to second generation INSTIs is rare and often without selection of known resistance mutations. Considering the use of INSTIs in first line regimens in high income countries and the increasing roll-out in lower and middle income countries, a better understanding of relevant resistance development and clinical failure is urgently needed.
The ROSETTA registry aims at systematically collecting otherwise scattered information on individual cases failing second generation integrase inhibitors, with the goal to inform policy and future use of INSTIs in the treatment of people living with HIV.
Attending physicians of individuals who are experiencing virological failure on a second generation integrase inhibitor-containing regimen are invited to contribute data to the registry.
Detailed description
The ROSETTA study collects clinical data and HIV sequences from individuals experiencing failure of ART containing second generation INSTIs from Americas, Africa and Europe. If resistance testing is not available, the ROSETTA team can perform genotypic resistance testing of RT, protease, integrase and 3'-PPT.
Research objectives:
To set up a database with data of individuals who have experienced virological failure on a regimen containing a second generation INSTI To determine the prevalence of resistance mutations in integrase and 3'-PPT in the dataset To identify possible new resistance mutations outside integrase and 3'-PPT. providing additional funding is retrieved.
The study design will be a multicenter observational cohort study. Patients will be included from HIV care centers in Europe, America and Africa, if they fullfill the inclusion criteria.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 1 Day
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- People living with HIV-1 experiencing virological failure to second-generation integrase inhibitors from Africa, Americas and Europe.
Key inclusion criteria (5 listed)
- Confirmed HIV-1 infection
- Using cART (any regimen) for at least the last 6 months
- Experiencing virological failure* on a second generation INSTI-containing regimen (including monotherapy and dual-therapy regimens)
- Data on current regimen and previous INSTI exposure available (start/stop dates and dosing mandatory)
- Integrase genotypic data available (performed locally) or a plasma/DBS (or CSF if available) sample(s) drawn at time of failure available to perform genotypic testing centrally * Virological failure is defined as at least 2 consecutive viral loads (VL) above 50 copies/mL in plasma or 1 VL above 200 copies/mL in plasma. We will also include patients who have a VL of >50 copies/mL in CSF, independent of the VL in plasma.
Key exclusion criteria (3 listed)
- Submitted fasta file not passing quality control and unavailability of a stored sample to repeat sequence analysis
- Missing Mandatory data
- Documented treatment interruption for at least 2 weeks prior to viral load testing.
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
Prevalence and patterns of resistance in the dataset
Time frame: 3 years
The prevalence of resistance in the dataset in relation to HIV subtype and collected clinical parameters
1 secondary outcome
Identify new mutations related to integrase inhibitor resistance
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2024.
- Results publication: PubMed 39513741Special Issue: Abstract Supplement HIV Glasgow 10-13 November 2024, Glasgow, UK/Virtual. J Int AIDS Soc. 2024 Nov;27 Suppl 6(Suppl 6):e26370. doi: 10.1002/jia2.26370. No abstract available.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. ROSETTA will not own the data
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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.
Annemarie MJ Wensing, MD,PhD principal investigator
UMC Utrecht
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 and Therapy Failure, run by UMC Utrecht at 1 site in Netherlands.
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 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: enrolling by invitation, as of the sponsor's last update on 27 Nov 2024. 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 Netherlands. 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?
This study is still under way. Results are not available in the source record yet.
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?
Prevalence and patterns of resistance in the dataset (time frame: 3 years). 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 NCT06706986, 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 27 Nov 2024.