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

NCT06706986 | Enrolling By Invitation DMC

• 1 other identifier: V0002187
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

integrase inhibitors; HIV drug resistance; subtype

Outcome Measures

Primary Outcomes (1)

• Prevalence and patterns of resistance in the dataset

  The prevalence of resistance in the dataset in relation to HIV subtype and collected clinical parameters

  3 years

Secondary Outcomes (1)

• Identify new mutations related to integrase inhibitor resistance

  3 years

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

People living with HIV-1 experiencing virological failure to second-generation integrase inhibitors from Africa, Americas and Europe.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• UMC Utrecht: lead
• Luxembourg Institute of Health: collaborator
• Erasmus Medical Center: collaborator

Study Sites (1)

University Medical Center Utrecht

Utrecht, Netherlands

Location

Related Publications (1)

• Special Issue: Abstract Supplement HIV Glasgow 10-13 November 2024, Glasgow, UK/Virtual. J Int AIDS Soc. 2024 Nov;27 Suppl 6(Suppl 6):e26370. doi: 10.1002/jia2.26370. No abstract available.

  PMID: 39513741 BACKGROUND

Related Links

• Related Info

Biospecimen

Retention: SAMPLES WITH DNA

If a center is not able to perform a genotypic resistance test, the ROSETTA team may isolate HIV DNA from a plasma sample to perform resistance testing.

Study Officials

• Annemarie MJ Wensing, MD,PhD

  UMC Utrecht

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Virologist

Study Record Dates

• First Submitted: November 22, 2024
• First Posted: November 27, 2024
• Study Start: September 1, 2023
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2025
• Last Updated: November 27, 2024

Record last verified: 2024-11

Locations

NL (1)