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

StatusActive, Not Recruiting
PhaseNot specified
Started
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Record History

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  1. Study completion date: Oct 2025 to Oct 31, 2026v4
  2. Primary completion date changed from estimate of Sep 1, 2021 to Dec 31, 2024v3 Show 7 more changesShow less
    • Start date changed from estimate of Sep 1, 2020 to Sep 1, 2023
    • Trial status: Not Yet Recruiting to Active, Not Recruiting
    • Study sites: 0 to 1
    • Study completion date: Jan 31, 2022 to Oct 2025
    • Secondary endpoints revised (2)
    • Study description shortened, about 21 words
    • Eligibility criteria expanded, about 1 word
  3. Primary endpoint revised
    • Study description shortened, about 747 words
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04453436
Lead Sponsor Federal University of São Paulo
Collaborators: Gilead Sciences
Conditions
(from sponsor)		 HIV, Drug, Resistance
Enrollment 2,500 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov