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

Launched by UMC UTRECHT · Nov 22, 2024

Keywords

ClinConnect Summary

This is a global registry called ROSETTA. It studies people with HIV who are not keeping the virus under control while taking second-generation integrase inhibitors (a type of HIV medicine). The goal is to learn how common resistance to these drugs is, how it relates to HIV subtypes and other patient factors, and to look for possible new resistance mutations. It’s an observational study (nothing is being tested as a new treatment), and researchers will collect clinical information and HIV genetic data from participants over about three years.

Who may be eligible? Adults and children with HIV-1 who have been on antiretroviral therapy for at least six months and are experiencing virological failure while on a second-generation integrase inhibitor–containing regimen (the study will have data on your current treatment and previous INSTI use). If local testing isn’t available, the study team may perform resistance testing on stored samples. Participation involves sharing medical information and, if needed, a blood or other program-supplied sample for testing. The registry is led by UMC Utrecht with international partners, and enrollment is by invitation. It does not involve a new treatment and is not a trial of a drug. Completion is estimated around September 2025.

Gender

ALL

Eligibility criteria

• 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.