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
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Laboratório de Retrovirologia, EP2 Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.