NCT06706986

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

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 250 (estimated)
• Sponsor: UMC Utrecht · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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. 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.

Conditions

• HIV
• Therapy Failure

Timeline

• Start date: 2023-09-01
• Primary completion: 2024-09-01
• Completion: 2025-09-01
• First posted: 2024-11-27
• Last updated: 2024-11-27

Locations

1 site across 1 country: Netherlands