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Evaluation of a Simplified Strategy for the Long-term Management of HIV Infection (Simpl'HIV) (Simpl'HIV)

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ClinicalTrials.gov Identifier: NCT03160105
Recruitment Status : Recruiting
First Posted : May 19, 2017
Last Update Posted : November 1, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to evaluate whether maintenance antiretroviral therapy could be simplified to DTG + FTC dual therapy and/or patient-centered monitoring once virological suppression is achieved. Using a factorial design, the study aims to assess the efficacy of DTG + FTC dual therapy to maintain virological suppression through 48 weeks of follow-up as well as the costs of a patient-centered ART laboratory monitoring.

Condition or disease Intervention/treatment Phase
HIV-1-infection Antiretroviral Therapy Maintenance Therapy Drug: Switch to DTG + FTC Other: Patient-centered monitoring Phase 4

Detailed Description:

This is a pragmatic multicentre, 2x2 factorial randomized controlled trial with 1:1:1:1 randomization to switching to DTG-based maintenance dual therapy in association with FTC or continuation of cART, and to patient-centered monitoring or continuation of standard monitoring.

Patients will be followed during 48 weeks.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 184 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: This is a pragmatic multicentre, 2x2 factorial randomized controlled trial with 1:1:1:1 randomization. A sample size of 92 patients in each group will be required to demonstrate non-inferiority with a non-inferiority (NI) margin of 12%.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of a Simplified Strategy for the Long-term Management of HIV Infection: a Non-inferiority, Randomized, Controlled, Open-label Clinical Trial
Actual Study Start Date : May 19, 2017
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
No Intervention: Continuing cART + Standard monitoring
Patients randomized to this arm will continue their current standard ART regimen (cART) and will continue a standard 3-monthly routine safety biological monitoring (including CD4 cell count, fasting lipids and glucose, renal and hepatic function tests) at their SHCS site.
Experimental: Continuing cART + Patient-centered monitoring
Patients randomized to this arm will continue their current cART and will have immunological and safety blood examinations performed once per year and at least one options (decentralised venipuncture and blood tests, delivery of ARV drugs by mail and interview by phone or skype call) for weeks 6, 12 and 36
Other: Patient-centered monitoring
Immunological and safety blood examinations performed only once per year at least one options (decentralised venipuncture and blood tests, delivery of ARV drugs by mail and interview by phone or skype call) for weeks 6, 12 and 36
Experimental: Switch to DTG+FTC + Standard monitoring
Patients randomized to this arm will be switched to DTG + FTC dual maintenance therapy and will have immunological and safety blood examinations performed once per year and at least one options (decentralised venipuncture and blood tests, delivery of ARV drugs by mail and interview by phone or skype call) for weeks 6, 12 and 36
Drug: Switch to DTG + FTC
Switch from standard cART to DTG + FTC dual maintenance therapy.
Experimental: Switch to DTG+FTC + Patient-centered monitoring
Patients randomized to this arm will be switched to DTG + FTC dual maintenance therapy and will have immunological and safety blood examinations performed at screening and at week 48. In addition, patients will be ask to choose at least one of the following alternative options for weeks 6, 12 and 36: decentralised venipuncture and blood tests, delivery of ARV drugs by mail and Assessment and clinical interview by phone or skype call
Drug: Switch to DTG + FTC
Switch from standard cART to DTG + FTC dual maintenance therapy.
Other: Patient-centered monitoring
Immunological and safety blood examinations performed only once per year at least one options (decentralised venipuncture and blood tests, delivery of ARV drugs by mail and interview by phone or skype call) for weeks 6, 12 and 36


Outcome Measures

Primary Outcome Measures :
  1. Efficacy of DTG-based maintenance therapy (< 100 copies/ml) [ Time Frame: 48 weeks ]
    Proportion of patients maintaining HIV-RNA <100 copies/ml throughout 48 weeks

  2. Costs of a patient-centered ART monitoring [ Time Frame: 48 weeks ]
    Direct costs of the two study arms from the health care system perspective at week 48


Secondary Outcome Measures :
  1. Efficacy of DTG-based maintenance therapy (<50 copies/ml) [ Time Frame: 48 weeks ]
    Proportion of patients maintaining HIV-RNA <50 copies/ml throughout 48 weeks

  2. Proportion of patients experiencing loss of future drug options [ Time Frame: 48 weeks ]
    Proportion of patients experiencing loss of future drug options

  3. Baseline HIV-DNA as a predictors of virological failure [ Time Frame: 48 weeks ]
    Baseline HIV-DNA as a predictors of virological failure

  4. nadir CD4 count as a predictors of virological failure [ Time Frame: 48 weeks ]
    nadir CD4 count as a predictors of virological failure

  5. ratio CD4/CD8 as a predictors of virological failure [ Time Frame: 48 weeks ]
    ratio CD4/CD8 as a predictors of virological failure

  6. peak HIV-RNA as a predictors of virological failure [ Time Frame: 48 weeks ]
    peak HIV-RNA as a predictors of virological failure

  7. age as a predictors of virological failure [ Time Frame: 48 weeks ]
    age as a predictors of virological failure

  8. years since HIV infection as a predictors of virological failure [ Time Frame: 48 weeks ]
    years since HIV infection as a predictors of virological failure

  9. years of HIV viral suppression as a predictors of virological failure [ Time Frame: 48 weeks ]
    years of HIV viral suppression as a predictors of virological failure

  10. dolutegravir plasma concentration as a predictors of virological failure [ Time Frame: 48 weeks ]
    dolutegravir plasma concentration as a predictors of virological failure

  11. dolutegravir pharmacogenetic variants as a predictors of virological failure [ Time Frame: 48 weeks ]
    dolutegravir pharmacogenetic variants as a predictors of virological failure

  12. Change in CD4 cell count [ Time Frame: 48 weeks ]
    from baseline to week 48

  13. Change in lipidic profile [ Time Frame: 48 weeks ]
    from baseline to week 48

  14. Change in Framingham-calculated cardiovascular risk [ Time Frame: 48 weeks ]
    from baseline to week 48

  15. Change in glomerular function rate [ Time Frame: 48 weeks ]
    from baseline to week 48

  16. Proportion of patients with an adverse event at week 48 [ Time Frame: 48 weeks ]
    Proportion of patients with an adverse event at week 48

  17. Proportion of patients with a severe adverse event at week 48 [ Time Frame: 48 weeks ]
    Proportion of patients with a severe adverse event at week 48

  18. Proportion of patients with CNS adverse event at week 48 [ Time Frame: 48 weeks ]
    Proportion of patients with CNS adverse event at week 48

  19. PROQOL questionnaire [ Time Frame: 48 weeks ]
    from baseline to weeks 12 and 48

  20. HIV-RNA >100 copies/ml as time to loss of virological response (TLOVR) [ Time Frame: 48 weeks ]
    defined as the first of the two-confirmed HIV-RNA >100 copies/ml (at least two weeks apart)

  21. Proportion of patients in the patient-centered monitoring arm expressing willingness to change monitoring options [ Time Frame: 48 weeks ]
    Monitoring satisfaction throughout 48 weeks

  22. Adherence questions [ Time Frame: 48 weeks ]
    Patient adherence to treatment throughout 48 weeks of follow-up

  23. Number of study-related extra clinical visits [ Time Frame: 48 weeks ]
    performed outside trial scheduled throughout 48 weeks

  24. Change in HIV-DNA [ Time Frame: 48 weeks ]
    from baseline to week 48


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Informed consent as documented by signature;
  2. Documented HIV-1 infection;
  3. Enrolled in the Swiss HIV Cohorte Study (SHCS) or receiving care from a medical doctor of the SHCS network;
  4. ≥ 18 years of age;
  5. HIV-RNA <50 copies/mL at screening and for at least 24 weeks before screening on effective suppressive cART, one blip with less than 200 copies/mL being allowed during this period if followed by at least 2 results < 50 copies/mL.
  6. On standard cART at the time of inclusion (EACS guidelines).

Exclusion Criteria:

  1. HIV-2 infection;
  2. Previous ART change for unsatisfactory virological response, i.e. slow initial virological suppression, incomplete suppression or rebound. Change of drug or drug class for convenience or toxic effect prevention or management is allowed.
  3. Creatinine clearance < 50ml/min;
  4. ASAT or ALAT >2.5x upper limit of the norm;
  5. Known hypersensitivity, intolerance or allergy to DTG or FTC;
  6. Known or suspected non-adherence (defined as <80% adherence, i.e. missed doses > 1x/week) to current treatment in the last 6 months;
  7. Concomitant use of drugs that decrease DTG blood concentrations including carbamazepine, oxcarbamazepine, phenytoin, phenobarbital, St John's wort and rifampicin;
  8. Women who are pregnant or breast-feeding;
  9. Intention to become pregnant during the course of the study;
  10. Lack of safe contraception, defined as: female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives or intrauterine contraceptive devices or barrier methods. Female participants who are surgically sterilised/hysterectomised or post-menopausal for longer than 2 years are not considered as being of child bearing potential.
  11. Presence of a M184V and/or INSTI-resistance on a routine resistance test documented in the patient chart. Non-availability of INSTI resistance testing is NOT an exclusion criteria;
  12. Evidence of acute or chronic hepatitis B virus infection based on results of serology testing.
Contacts and Locations

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): NCT03160105


Contacts
Contact: Alexandra Calmy, MD PhD +4122 37 29 811 alexandra.calmy@hcuge.ch
Contact: Marta Buzzi, MD +4179 55 33 324 marta.buzzi@hcuge.ch

Locations
Switzerland
Department of Infectious Diseases and Hospital Epidemiology, University Hospital of Basel Recruiting
Basel, Switzerland
Principal Investigator: Marcel Stoeckle, MD         
Departement of Infectious Disease, Bern University Hospital Recruiting
Bern, Switzerland
Principal Investigator: Gilles Wandeler, MS, MSc         
Infectious diseases consultation, University Hospitals of Geneva Recruiting
Genève, Switzerland
Principal Investigator: Delphine Sculier, MD, MSc         
Infectious Diseases Service, Lausanne University Hospital Recruiting
Lausanne, Switzerland
Principal Investigator: Matthias Cavassini, MD, PD         
Department of Infectious Diseases, Lugano Regional Hospital Recruiting
Lugano, Switzerland
Principal Investigator: Enos Bernasconi, PhD         
Division of Infectious Diseases and Hospital Epidemiology, Kantonspital St.Gallen Recruiting
St. Gallen, Switzerland
Principal Investigator: Patrick Schmid         
Department of Infectious Diseases and Hospital Epidemiology, University Hospital of Zurich Recruiting
Zürich, Switzerland
Principal Investigator: Dominique Braun         
Sponsors and Collaborators
Calmy Alexandra
More Information

Responsible Party: Calmy Alexandra, Professor, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT03160105     History of Changes
Other Study ID Numbers: CCER 2016-02210
First Posted: May 19, 2017    Key Record Dates
Last Update Posted: November 1, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Infection
Communicable Diseases
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases