A Global Registry on Second GEneration and Long-acting InTegrase InhibiTor FAilures

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-01

Study Completion Date

2025-09-01

Brief Summary

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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

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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

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HIV Therapy Failure

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Dr. Annemarie Wensing

Clinical Virologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Annemarie MJ Wensing, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

UMC Utrecht

Locations

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University Medical Center Utrecht

Utrecht, , Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type BACKGROUND

PMID: 39513741 (View on PubMed)

Other Identifiers

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V0002187

Identifier Type: -

Identifier Source: org_study_id