NCT06706986Enrolling by invitation
A Global Registry On Second gEneration and Long-acting inTegrase inhibiTor fAilures
ROSETTA- A Global Registry On Second gEneration and Long-acting inTegrase inhibiTor fAilures
Source: ClinicalTrials.gov · Last updated 27 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Observational
- Enrollment
- 250 (estimated)
- First submitted
- 22 Nov 2024
- Start date
- Sept 2023
- Primary completion date
- Sept 2024
- Lead sponsor
- UMC Utrecht
- Diseases
- HIV
- NCT number
- NCT06706986
What you commit to
- Study type: Observational
- Planned participants: 250
- From Sept 2023 to the primary completion date, Sept 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Documented treatment interruption for at least 2 weeks prior to viral load testing.
Other
- Submitted fasta file not passing quality control and unavailability of a stored sample to repeat sequence analysis
- Missing Mandatory data
Who the study is looking for
- 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.
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Medical Center Utrecht Coordinator of this site? Confirm its status | Utrecht | Netherlands | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.