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

NCT06706986 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 250

Last updated 2024-11-27

No results posted yet for this study

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.

Conditions

  • HIV
  • Therapy Failure

Sponsors & Collaborators

  • Luxembourg Institute of Health

    collaborator OTHER_GOV

  • Erasmus Medical Center

    collaborator OTHER

  • UMC Utrecht

    lead OTHER

Principal Investigators

  • Annemarie MJ Wensing, MD,PhD · UMC Utrecht

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-01
Primary Completion
2024-09-01
Completion
2025-09-01

Countries

  • Netherlands

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06706986 on ClinicalTrials.gov