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 : Active, not recruiting

First Posted : May 19, 2017

Last Update Posted : July 24, 2018

Sponsor:

Information provided by (Responsible Party):

Calmy Alexandra, University Hospital, Geneva

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)
Actual Enrollment :	186 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 :

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
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 :

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
Efficacy of DTG-based therapy (<50 copies/ml) by FDA snapshot analysis [ Time Frame: 48 weeks ]
Proportion of patients with HIV-RNA < 50 cp/ml at week 48
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)
Change in CD4 cell count [ Time Frame: 48 weeks ]
from baseline to week 48
Change in HIV-DNA [ Time Frame: 48 weeks ]
from baseline to week 48
Change in lipidic profile [ Time Frame: 48 weeks ]
from baseline to week 48
Change in glucose profile [ Time Frame: 48 weeks ]
from baseline to week 48
Change in Framingham-calculated cardiovascular risk [ Time Frame: 48 weeks ]
from baseline to week 48
Change in glomerular function rate [ Time Frame: 48 weeks ]
from baseline to week 48
Proportion of patients with an adverse event [ Time Frame: 48 weeks ]
throughout week 48
Proportion of patients with a severe adverse event [ Time Frame: 48 weeks ]
throughout week 48
Proportion of patients with CNS adverse event [ Time Frame: 48 weeks ]
throughout week 48
Proportion of patients new to DTG with CNS symptoms [ Time Frame: 6 weeks ]
at 2 and 6 week
PROQOL questionnaire [ Time Frame: 48 weeks ]
from baseline to weeks 12 and 48
Patient's monitoring satisfaction for pts in the patient-centered monitoring arm [ Time Frame: 48 weeks ]
from baseline to weeks 24 and 48
Global satisfaction of the monitoring [ Time Frame: 48 weeks ]
at week 48
Proportion of patients in the patient-centered monitoring arm expressing willingness to change monitoring options [ Time Frame: 48 weeks ]
Monitoring satisfaction throughout 48 weeks
Patient's treatment satisfaction at week 48 [ Time Frame: 48 weeks ]
at week 48
ARV treatment in the post study [ Time Frame: 48 weeks ]
ART decided to be used in the post study period
Study satisfaction [ Time Frame: 48 weeks ]
at week 48
Cost-effectiveness of study arms [ Time Frame: 48 weeks ]
at week 48
Change in patient weight [ Time Frame: 48 weeks ]
from baseline to week 48
Adherence questions [ Time Frame: 48 weeks ]
Patient adherence to treatment throughout 48 weeks of follow-up
Number of study-related extra clinical visits [ Time Frame: 48 weeks ]
performed outside trial scheduled throughout 48 weeks

Eligibility Criteria

Information from the National Library of Medicine

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

Criteria

Inclusion Criteria:

Informed consent as documented by signature;
Documented HIV-1 infection;
Enrolled in the Swiss HIV Cohorte Study (SHCS) or receiving care from a medical doctor of the SHCS network;
≥ 18 years of age;
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.
On standard cART at the time of inclusion, i.e.:
- 2 NRTIs + either 1 NNRTI, 1 boosted PI or 1 INSTI;
- NRTI-sparing triple ARV regimen (e.g. 1 NRTI + 1 NNRTI + 1 InSTI);
- Dual therapy with protease inhibitor.

Exclusion Criteria:

HIV-2 infection;
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.

Note: patients with documented genotype(s) presenting only a M184V mutation remain eligible;
Creatinine clearance < 50ml/min;
ASAT or ALAT >2.5x upper limit of the norm;
Known hypersensitivity, intolerance or allergy to DTG or FTC;
Known or suspected non-adherence (defined as <80% adherence, i.e. missed doses > 1x/week) to current treatment in the last 6 months;
Concomitant use of drugs that decrease DTG blood concentrations including carbamazepine, oxcarbamazepine, phenytoin, phenobarbital, St John's wort and rifampicin;
Women who are pregnant or breast-feeding;
a. Presence of any INSTI-resistance. Non-availability of INSTI resistance testing is NOT an exclusion criteria.

b. Non availability of previous routine resistance test, at least for reverse transcriptase and protease genes.

Note: Subjects remain eligible in the absence of any previous resistance test only if they are on their first-line antiretroviral regimen;
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

Locations


Switzerland
Department of Infectious Diseases and Hospital Epidemiology, University Hospital of Basel
Basel, Switzerland
Departement of Infectious Disease, Bern University Hospital
Bern, Switzerland
Infectious diseases consultation, University Hospitals of Geneva
Genève, Switzerland
Infectious Diseases Service, Lausanne University Hospital
Lausanne, Switzerland
Department of Infectious Diseases, Lugano Regional Hospital
Lugano, Switzerland
Division of Infectious Diseases and Hospital Epidemiology, Kantonspital St.Gallen
St. Gallen, Switzerland
Department of Infectious Diseases and Hospital Epidemiology, University Hospital of Zurich
Zürich, Switzerland

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:	July 24, 2018
Last Verified:	July 2018
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

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