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Clinical Trials in Brazil / NCT04453436
Active, not recruiting Observational

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

NCT04453436 · tracked via the Priya Life Science Brazil tracker
Sponsor
Federal University of São Paulo
Phase
Observational
Started
2023-09-01
Last updated
2026-06-01

Condition(s) studied

HIVDrugResistance

Investigational drug(s) / intervention(s)

Tenofovir Disoproxil →

Tenofovir Disoproxil: Genotipic resistance test

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria: * Patints starting first line anti HIV treatment with Tenofovir/laimudine + Dolutegravir * No previous antiretroviral treatment * ≥ 18 ≤ 65 y.o Exclusion Criteria: • Not to be able to understand and sign the informed consent form

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Laboratório de Retrovirologia, EP2 São Paulo São Paulo

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04453436 on ClinicalTrials.gov ↗ ← All trials in Brazil