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

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ClinicalTrials.gov Identifier: NCT04453436
Recruitment Status : Not yet recruiting
First Posted : July 1, 2020
Last Update Posted : July 24, 2020
Sponsor:
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
Ricardo Sobhie Diaz, MD, PHD, Federal University of São Paulo

Brief 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.

Condition or disease Intervention/treatment
HIV Drug Resistance Drug: Tenofovir Disoproxil

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 2500 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 24 Months
Official Title: HIV Drug Resistance Profiles Among Individuals Failing Tenofovir/Lamivudine and Dolutegravir First Line Regimen in Brazil
Estimated Study Start Date : September 1, 2020
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : January 31, 2022


Group/Cohort Intervention/treatment
Virologic failure
Viral load above detection limits at window period
Drug: Tenofovir Disoproxil
Genotipic resistance test
Other Names:
  • Lamivudine
  • Dolutegravir

Virologic Success
Viral load bellow detection limits at window period
Drug: Tenofovir Disoproxil
Genotipic resistance test
Other Names:
  • Lamivudine
  • Dolutegravir




Primary Outcome Measures :
  1. HIV RNA Viral Load [ Time Frame: 24 weeks ]
    Viral load in patient trated with first line treatment withTenofovir/3TC + Dolutegravir


Secondary Outcome Measures :
  1. HIV transcriptase resitance mutations [ Time Frame: 24 weeks ]
    HIV reverse transcriptase resistance test in virologic failure patient

  2. HIV integrase resitance mutations [ Time Frame: 24 weeks ]
    HIV transcriptase resistance test in virologic failure patient


Biospecimen Retention:   Samples Without DNA
plasma sample


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
2500 HIV positive brazilian
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04453436


Contacts
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Contact: Ricardo S Diaz, MD., PhD +55 11 991090445 rsdiaz@catg.com.br
Contact: Tania R. C. Vergara, MD, PhD +55 21 991621308 taniavergara@globo.com

Sponsors and Collaborators
Federal University of São Paulo
Gilead Sciences
Publications:
World Health Organization. Updated Recommendations on First-Line and Second-Line Antiretroviral Regimens and Post-Exposure Prophylaxis and Recommendations on Early Infant Diagnosis of HIV: Interim Guidance. Geneva: World Health Organization; 2018 (WHO/CDS/HIV/18.18). Licence: CC BY.; 2018.
World Health Organization. Transition to new antiretrovirals in HIV programmes: Policy brief. WHO/HIV/2017.20. 2017.

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Responsible Party: Ricardo Sobhie Diaz, MD, PHD, Associate Professor, Paulista School of Infectious Diseases, Federal University of Sao Paulo, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT04453436    
Other Study ID Numbers: SPARC-8
First Posted: July 1, 2020    Key Record Dates
Last Update Posted: July 24, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Ricardo Sobhie Diaz, MD, PHD, Federal University of São Paulo:
HIV
treatment
resistance
Additional relevant MeSH terms:
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Tenofovir
Lamivudine
Dolutegravir
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents
HIV Integrase Inhibitors
Integrase Inhibitors