Fact CheckerSign in

NCT04453436Active, not recruiting

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

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

Source: ClinicalTrials.gov · Last updated 1 Jun 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
2500 (estimated)
First submitted
27 Jun 2020
Start date
1 Sept 2023
Primary completion date
31 Dec 2024
Lead sponsor
Federal University of São Paulo
Diseases
HIV
NCT number
NCT04453436

What you commit to

  • Study type: Observational
  • Planned participants: 2500
  • From 1 Sept 2023 to the primary completion date, 31 Dec 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • Not to be able to understand and sign the informed consent form

Who the study is looking for

  • Patints starting first line anti HIV treatment with Tenofovir/laimudine + Dolutegravir
  • No previous antiretroviral treatment
  • ≥ 18 ≤ 65 y.o

Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Laboratório de Retrovirologia, EP2
Coordinator of this site? Confirm its status
São PauloBrazilUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.