Registry collecting information on people with HIV whose integrase inhibitor treatment fails
Collects records of people with HIV whose second generation integrase inhibitor treatment stopped working.
Plain-language title generated from the registry record
Registry title: A Global Registry On Second gEneration and Long-acting inTegrase inhibiTor fAilures
Key facts
- Where
- Utrecht, NetherlandsSee the site
Where in Netherlands
- University Medical Center UtrechtUtrecht, NetherlandsNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- UMC Utrecht
- Trial code
- NCT06706986
- Record updated
- 27 November 2024
- Original description
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 full original descriptionShow less
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.
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.
Inclusion: 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: Documented treatment interruption for at least 2 weeks prior to viral load testing; Submitted fasta file not passing quality control and unavailability of a stored sample to repeat sequence analysis; Missing Mandatory data.