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HIV-1 Subtype-specific Drug Resistance in Patients Failing Dolutegravir (DTG) Based Regimen

NCT06285110 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1103

Last updated 2025-11-25

No results posted yet for this study

Summary

This is a prospective observational study enrolling People Living with HIV (PLHIV) who are on a Dolutegravir-based AntiRetroviral Treatment (ART) regimen and experiencing virologic failure. Virologic failure is defined as two consecutive viral load measurements of \>1000 copies/mL of blood. The main aim of the study is to identify the drug-resistance mutations in the viral genome that are associated with this failure.

To achieve this goal, patients fulfilling the eligibility criteria will be invited for a single study visit for the collection of blood. The extracted HIV virus will be sequenced through whole genome sequencing methods to identify the drug-resistance mutations. The study is conducted in 15-20 countries within six regions of the IeDEA cohort (International epidemiology Databases to Evaluate AIDS).

Conditions

Sponsors & Collaborators

  • University of Zurich

    collaborator OTHER

  • ETH Zurich

    collaborator OTHER

  • University of KwaZulu

    collaborator OTHER

  • University of Bristol

    collaborator OTHER

  • University of Bern

    lead OTHER

Principal Investigators

  • Matthias Egger, Prof. Dr. · Institute of Social and Preventive Medicine (ISPM), University of Bern, Switzerland

  • Richard Lessells, Dr. · KwaZulu-Natal Research Innovation & Sequencing Platform, University of KwaZulu-Natal, South Africa

  • Roger Kouyos, Prof. Dr. · Department of Infectious Diseases and Hospital Epidemiology, University of Zürich, Switzerland

  • Jonathan Sterne, Prof. Dr. · University of Bristol

  • Niko Beerenwinkel, Prof. Dr. · ETH Zurich (Switzerland)

Eligibility

Min Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-13
Primary Completion
2025-08-31
Completion
2025-08-31

Countries

  • Argentina
  • Brazil
  • Burkina Faso
  • Cambodia
  • Cameroon
  • Côte d’Ivoire
  • Kenya
  • Malawi
  • Mexico
  • Republic of the Congo
  • Rwanda
  • Tanzania
  • Thailand
  • Uganda
  • Zambia
  • Zimbabwe

Study Locations

More Related Trials

Entities

Diseases

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 NCT06285110 on ClinicalTrials.gov