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Switching TDF/FTC/EFV to TDF/FTC/RPV VS Continuing TDF/FTC/EFV in HIV Patients With Complete Virological Suppression (STEREOS)

Primary Purpose

Anti-Retroviral Agents, Efavirenz, HIV-1-infection

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Tenofovir/Emtricitabine/Rilpivirine
Tenofovir/Emtricitabine/Efavirenz
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anti-Retroviral Agents

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • on TDF/FTC/EFV for more than 3 months
  • Blood HIV RNA viral load <50 copies/mL
  • CD4+ count >200 cells/mm3
  • eligible to sign the informed consent

Exclusion Criteria:

  • history of NRTI resistance
  • on medication that potentially interact with study drug
  • denied to participate in the study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Switching TDF/FTC/EFV to TDF/FTC/RPV

    Continuing TDF/FTC/EFV

    Arm Description

    Switching from Tenofovir 300 mg/day + Emtricitabine 200 mg/day + Efavirenz 600 mg/day (once daily) to Tenofovir 300 mg/day + Emtricitabine 200 mg/day + Rilpivirine 25 mg/day (once daily) Intervention: Tenofovir/Emtricitabine/Rilpivirine

    Continuing Tenofovir 300 mg/day + Emtricitabine 200 mg/day + Efavirenz 600 mg/day Intervention: Tenofovir/Emtricitabine/Efavirenz

    Outcomes

    Primary Outcome Measures

    Sustained virological response
    maintain the undetectable HIV viral load

    Secondary Outcome Measures

    Lipid adverse outcome
    Different in blood lipid profiles, including triglycerides, cholesterol, HDL, and LDL
    Neurological adverse outcome
    Neurological adverse events such as dizziness
    Cost -saving after switching regimens

    Full Information

    First Posted
    August 14, 2017
    Last Updated
    May 4, 2019
    Sponsor
    Mahidol University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03251690
    Brief Title
    Switching TDF/FTC/EFV to TDF/FTC/RPV VS Continuing TDF/FTC/EFV in HIV Patients With Complete Virological Suppression
    Acronym
    STEREOS
    Official Title
    Switching Tenofovir/Emtricitabine/Efavirenz to Tenofovir/Emtricitabine/Rilpivirine Versus Continuing Tenofovir/Emtricitabine/Efavirenz in HIV1-infected Patients With Complete Virological Suppression
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    October 27, 2016 (Actual)
    Primary Completion Date
    April 30, 2018 (Actual)
    Study Completion Date
    April 30, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Mahidol University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    According to the Thai National Guidelines for Treatment of HIV/AIDS 2014, the recommended first line ART regimen was 2 NRTIs backbone, TDF and FTC; plus 1 NNRTI, EFV, with RPV as an alternative one. Most of the randomized-controlled studies, including ECHO and THRIVE, showed the non-inferiority of RPV compared with EFV in naive cases. But there were not much randomized-controlled trials for changing from other NRTI to RPV in patients who currently on another ART, especially in Thailand. Moreover, the concerned adverse effects of dyslipidemia and neurological symptoms were better in RPV-based than EFV-based regimen. Finally, the cost-effectiveness and universal coverage are also the benefit of RPV over EFV in term of economics.
    Detailed Description
    According to the Thai National Guidelines for Treatment of HIV/AIDS 2014, the recommended first line ART (Anti-retroviral therapy) regimen was 2 NRTIs (nucleoside reverse transcriptase inhibitors) backbone, which are TDF (Tenofovir) and FTC (Emtricitabine); plus 1 NNRTI (non-nucleoside reverse transcriptase inhibitor), which is EFV (Efavirenz), with RPV (Rilpivirine) as an alternative in this class of drug. Most of the randomized-controlled studies, including ECHO (Rilpivirine versus efavirenz with tenofovir and emtricitabine in treatment-naive adults infected with HIV-1) and THRIVE (Rilpivirine versus efavirenz with two background nucleoside or nucleotide reverse transcriptase inhibitors in treatment-naive adults infected with HIV-1), the major trials about RPV, showed the non-inferiority in efficacy of RPV compared with that of EFV in treatment-naive cases with blood HIV viral load less than 500,000 copies/mL. But there were not many trials focusing on changing the ART-regimens from other NRTI to RPV in patients who currently on another ART, especially in randomized-controlled design. There were some studies comparing continuing current regimens versus changing to Rilpivirine-based regimens, but they didn't exclusively select the homogeneous drug components. In Thailand, study of changing to Rilpivirine-based regimens was primarily designed to evaluate the adverse outcome about dyslipidemia, whereas efficacy was a secondary outcome. Most studies, the concerned adverse effects of dyslipidemia and neurological symptoms were better in RPV-based than EFV-based regimen. Finally, the cost-effectiveness and universal coverage are also the benefit of RPV over EFV in term of economics. Therefore, we design this study to evaluate the efficacy; in term of non-inferiority, of the newer, safer, and cheaper drug, Rilpivirine, to Efavirenz, the general-use drug with acceptable efficacy, in the virological-suppressed patients currently on ART. Besides, we also assess the adverse outcomes and factors associated with successful or failure of treatment. In addition, we can have more backup data in term of national economics.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anti-Retroviral Agents, Efavirenz, HIV-1-infection, Sustained Virologic Response, Dyslipidemias, Rilpivirine

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    246 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Switching TDF/FTC/EFV to TDF/FTC/RPV
    Arm Type
    Experimental
    Arm Description
    Switching from Tenofovir 300 mg/day + Emtricitabine 200 mg/day + Efavirenz 600 mg/day (once daily) to Tenofovir 300 mg/day + Emtricitabine 200 mg/day + Rilpivirine 25 mg/day (once daily) Intervention: Tenofovir/Emtricitabine/Rilpivirine
    Arm Title
    Continuing TDF/FTC/EFV
    Arm Type
    Active Comparator
    Arm Description
    Continuing Tenofovir 300 mg/day + Emtricitabine 200 mg/day + Efavirenz 600 mg/day Intervention: Tenofovir/Emtricitabine/Efavirenz
    Intervention Type
    Drug
    Intervention Name(s)
    Tenofovir/Emtricitabine/Rilpivirine
    Other Intervention Name(s)
    TDF/FTC/RPV
    Intervention Description
    Tenofovir/Emtricitabine/Rilpivirine to compare the non-inferiority of efficacy and adverse effects to Tenofovir/Emtricitabine/Efavirenz in patients with virological suppression
    Intervention Type
    Drug
    Intervention Name(s)
    Tenofovir/Emtricitabine/Efavirenz
    Other Intervention Name(s)
    TDF/FTC/EFV
    Intervention Description
    as a active comparator
    Primary Outcome Measure Information:
    Title
    Sustained virological response
    Description
    maintain the undetectable HIV viral load
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    Lipid adverse outcome
    Description
    Different in blood lipid profiles, including triglycerides, cholesterol, HDL, and LDL
    Time Frame
    12 months
    Title
    Neurological adverse outcome
    Description
    Neurological adverse events such as dizziness
    Time Frame
    12 months
    Title
    Cost -saving after switching regimens
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: on TDF/FTC/EFV for more than 3 months Blood HIV RNA viral load <50 copies/mL CD4+ count >200 cells/mm3 eligible to sign the informed consent Exclusion Criteria: history of NRTI resistance on medication that potentially interact with study drug denied to participate in the study
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sirichai Wiriyatanakorn, MD
    Organizational Affiliation
    Department of Internal Medicine, Faculty of Medicine, Ramathibodi Hospital, Mahidol University
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Somneuk Sungkanuparp, MD
    Organizational Affiliation
    Department of Internal Medicine, Faculty of Medicine, Ramathibodi Hospital, Mahidol University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    Citation
    Thai AIDS Society. Thailand National Guidelines on HIV/AIDS Treatment and Prevention 2014. Nontaburi: Bureau of AIDS, TB, and STIs, 2014.
    Results Reference
    background
    PubMed Identifier
    21763936
    Citation
    Molina JM, Cahn P, Grinsztejn B, Lazzarin A, Mills A, Saag M, Supparatpinyo K, Walmsley S, Crauwels H, Rimsky LT, Vanveggel S, Boven K; ECHO study group. Rilpivirine versus efavirenz with tenofovir and emtricitabine in treatment-naive adults infected with HIV-1 (ECHO): a phase 3 randomised double-blind active-controlled trial. Lancet. 2011 Jul 16;378(9787):238-46. doi: 10.1016/S0140-6736(11)60936-7.
    Results Reference
    result
    PubMed Identifier
    21763935
    Citation
    Cohen CJ, Andrade-Villanueva J, Clotet B, Fourie J, Johnson MA, Ruxrungtham K, Wu H, Zorrilla C, Crauwels H, Rimsky LT, Vanveggel S, Boven K; THRIVE study group. Rilpivirine versus efavirenz with two background nucleoside or nucleotide reverse transcriptase inhibitors in treatment-naive adults infected with HIV-1 (THRIVE): a phase 3, randomised, non-inferiority trial. Lancet. 2011 Jul 16;378(9787):229-37. doi: 10.1016/S0140-6736(11)60983-5.
    Results Reference
    result
    PubMed Identifier
    26739573
    Citation
    Thamrongwonglert P, Chetchotisakd P, Anunnatsiri S, Mootsikapun P. Improvement of lipid profiles when switching from efavirenz to rilpivirine in HIV-infected patients with dyslipidemia. HIV Clin Trials. 2016 Feb;17(1):12-6. doi: 10.1080/15284336.2015.1112480. Epub 2016 Jan 7.
    Results Reference
    result
    PubMed Identifier
    26232000
    Citation
    Gianotti N, Poli A, Nozza S, Spagnuolo V, Tambussi G, Bossolasco S, Cinque P, Maillard M, Cernuschi M, Galli L, Lazzarin A, Castagna A. Efficacy and safety in clinical practice of a rilpivirine, tenofovir and emtricitabine single-tablet regimen in virologically suppressed HIV-positive patients on stable antiretroviral therapy. J Int AIDS Soc. 2015 Jul 30;18(1):20037. doi: 10.7448/IAS.18.1.20037. eCollection 2015.
    Results Reference
    result

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    Switching TDF/FTC/EFV to TDF/FTC/RPV VS Continuing TDF/FTC/EFV in HIV Patients With Complete Virological Suppression

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