Switch From Dual Regimens Based on Dolutegravir Plus a Reverse Transcriptase Inhibitor to E/C/F/TAF in Virologically Suppressed, HIV-1 Infected Patients (Be-OnE) (Be-OnE)

February 7, 2024 updated by: Castagna Antonella, IRCCS San Raffaele

Open Label, Randomized (1:1) Clinical Trial to Evaluate Switching From Dual Regimens Based on Dolutegravir Plus a Reverse Transcriptase Inhibitor to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed, HIV-1 Infected Patients (Be-OnE Study).

Research hypothesis:

Switching from dual regimens based on dolutegravir plus a RTI to a single tablet regimen of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF), lowers the exposure to Residual Viremia (and hence the risk of viral rebound), without increasing treatment toxicity.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Study design Randomized, single-center, open-label, 96-week superiority study. Patients with HIV-RNA <50 copies/mL while receiving DTG plus one RTI will be randomized 1:1 to continue the ongoing treatment or to switch to E/C/F/TAF.

Randomization list will be a computer-generated list (with equal block sizes) and will be incorporated within an electronic clinical report form (eCRF).

Patients will be evaluated at screening, baseline, week 4, 8, 16, 24, 32, 40, 48, 60, 72, 84, 96 or premature discontinuation.

At each visit the following evaluations will be performed:

  1. clinical assessment.
  2. routine laboratory tests (hematological tests and clinical chemistry). Additional blood samples will be collected at specified visits for storage and further determinations (e.g. RV by a single-copy assay).

During follow-up, at different timepoints, patients will additionally undergo HIV-DNA quantification in PBMCs (BL, 48 and 96 weeks) and quality of life (QOL) and adherence assessement (BL, 48 and 96 weeks).

Viral load will be assessed by Abbott Real time PCR (Abbott RealTime HIV-1) Residual viremia (RV) will be defined as any detectable HIV-RNA value below 50 copies/mL Virologic failure will be defined as a confirmed rebound in plasma HIV-RNA levels ≥ 50 copies/mL

Subjects who meet a protocol-defined virologic failure during follow-up will be discontinued from the study.

At virologic failure subjects will perform genotypic HIV resistance testing and a determination in plasma of elvitegravir or DTG Cthrough.

HIV-DNA will be extracted from 1x106 peripheral blood mononuclear cells (PBMCs) by using Qiagen DNA extraction kit and quantified by Real Time PCR (ABI Prism 7900).

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Milan, Italy, 20127
        • Ospedale San Raffaele Scientific Institute
    • Lombardia
      • Milan, Lombardia, Italy, 20127
        • Ospedale San Raffaele

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age >18 years
  2. Willing and able to provide informed consent
  3. On a stable (at least 3 months) antiretroviral therapy with DTG 50 mg QD plus one RTI
  4. HIV-RNA <50 copies/mL since at least 6 months

Exclusion Criteria:

  1. Active AIDS-defining condition (except Kaposi's sarcoma non requiring systemic chemotherapy)
  2. Serious illness requiring systemic treatment and/or hospitalization
  3. Current use of immunomodulant or immunosuppressive drugs
  4. Need (or will likely need) of treatment with antacids
  5. Use of drugs contraindicated with study drugs, according to technical sheets
  6. Previous suboptimal therapies with NRTIs or presence of TAMs (type 1 or 2) in previous resistance tests (patients with the 184I/V mutation alone are allowed to enter the study)
  7. Resistance or previous virological failure to InSTIs
  8. Detectable HCV-RNA
  9. Documented allergy to COBI or EVG or FTC or tenofovir.
  10. Absolute neutrophil count (ANC) <500/µL
  11. Haemoglobin <8.0 g/dL
  12. Platelet count <50,000/µL
  13. eGFR <30 mL/min/1.73m2 by CKD-EPI equation
  14. Alanine aminotransferase (ALT) more than 5 times the upper limit of normal (ULN)
  15. Presence of Child Pugh Class B or C liver cirrhosis.
  16. Pregnancy or breastfeeding
  17. Woman of childbearing potential who does not agree to adopt highly effective contraception.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Genvoya 150Mg-150Mg-200Mg-10Mg Table
switch to the treatment Genvoya 150Mg-150Mg-200Mg-10Mg Table (1 pill every 24 hour)
Drug: Genvoya 150Mg-150Mg-200Mg-10Mg Tablet
switch to Genvoya 150Mg-150Mg-200Mg-10Mg Tablet in patients virologically suppressed HIV-1 infected patients.
Active Comparator: Dolutegravir 50 mg plus one RTI (at label dose)
Continuing Dolutegravir 50 mg (1 pill every 24 hours) plus one RTI (at label dose)
Drug: Dolutegravir 50 mg plus one RTI
Continuing Dolutegravir 50 mg (1 pill every 24 hours) plus one RTI (at label dose)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Residual Viremia
Time Frame: 48 weeks
To investigate RV through 48 weeks in virologically suppressed patients randomized to continue treatment with DTG plus a single RTI or to switch to E/C/F/TAF.
48 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
virological rebound
Time Frame: 48 weeks
To investigate the occurrence of virological rebound above 50 HIV-RNA copies/mL;
48 weeks
viral reservoir
Time Frame: 48 weeks
To investigate changes in viral reservoir (HIV-DNA)
48 weeks
QOL
Time Frame: 48 weeks
To investigate changes in the quality of life (administration of questionnaire ISSQoL uses five- point Likert scales 1 never 2 rarely 3 sometimes 4 often 5 always)
48 weeks
Adherence
Time Frame: 48 weeks
To investigate changes in adherence (administration of questionnaire uses scale ranges from 0 to 100)
48 weeks
Virological failure
Time Frame: 96 weeks
proportion of patient in virological rebound
96 weeks
viral reservoir
Time Frame: 96 weeks
change in viral reservoir (HIV-DNA extracted from peripheral blood mononuclear cells by using Qiagen DNA extraction kit and quantified by Real Time PCR)
96 weeks
QOL
Time Frame: 96 weeks
To investigate changes in the quality of life (administration of questionnaire To investigate changes in the quality of life (administration of questionnaire ISSQoL uses five- point Likert scales 1 never 2 rarely 3 sometimes 4 often 5 always))
96 weeks
Adherence.
Time Frame: 96 weeks
To investigate changes in adherence (administration of questionnaire uses scale ranges from 0 to 100 )
96 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS San Raffaele

Collaborators

Gilead Sciences

Investigators

  • Principal Investigator: Adriano Lazzarin, Prof, Ospedale San Raffaele

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 6, 2017

Primary Completion (Actual)

March 20, 2018

Study Completion (Actual)

July 31, 2020

Study Registration Dates

First Submitted

March 27, 2018

First Submitted That Met QC Criteria

April 3, 2018

First Posted (Actual)

April 10, 2018

Study Record Updates

Last Update Posted (Estimated)

February 9, 2024

Last Update Submitted That Met QC Criteria

February 7, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Be-OnE Study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data shared in Scientific Congress (abstract and pubblications)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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