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HIV Drug Resistance Among Individuals Failing Tenofovir/Lamivudine and Dolutegravir First Line Regimen in Brazil

NCT04453436 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 2500

Last updated 2025-08-08

No results posted yet for this study

Summary

Brazil was the first middle-income country to provide free and universal access to antiretroviral drugs to HIV infected individuals. Since 2014 local guidelines recommend that all HIV infected individuals be started on therapy regardless of CD4 count. Since January 2017, all patients are started on a DTG containing triple regimen. As of November 2018, 170,000 individuals were receiving DTG through the public health system. It is a public health priority to evaluate the risk of virologic failure and the subsequent development of INSTI resistance in these real-life settings. Our preliminary data from Brazil indicated a high virologic failure rate of 8% after 18 months of treatment TL+D. Our central hypothesis is that TDR may be associated and contribute to virologic failure with DTG in clinical practice. To test this central hypothesis, we will identify PLWH failing DTG containing regimens in Brazil. The insights generated with these studies will contribute to a more effective use of second generation INSTI in the future.

Conditions

  • HIV
  • Drug
  • Resistance

Interventions

DRUG

Tenofovir Disoproxil

Genotipic resistance test

Sponsors & Collaborators

  • Gilead Sciences

    collaborator INDUSTRY

  • Federal University of São Paulo

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-01
Primary Completion
2024-12-31
Completion
2025-10-31
FDA Drug
Yes

Countries

  • Brazil

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 NCT04453436 on ClinicalTrials.gov