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

Calmy Alexandra186 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

186

Conditions

HIV-1-infection Antiretroviral Therapy Maintenance Therapy

Interventions

Switch to DTG + FTCDRUG

Switch from standard cART to DTG + FTC dual maintenance therapy.

Patient-centered monitoringOTHER

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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, 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: 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. Note: patients with documented genotype(s) presenting only a M184V mutation remain eligible; 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. 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; 10. Evidence of acute or chronic hepatitis B virus infection based on results of serology testing.

Locations (7)

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

Geneva, Switzerland

Outcomes

Primary Outcomes

Efficacy of DTG-based maintenance therapy (< 100 copies/ml)

Proportion of patients maintaining HIV-RNA \<100 copies/ml throughout 48 weeks

Time frame: 48 weeks

Costs of a patient-centered ART monitoring

Direct costs of the two study arms from the health care system perspective at week 48

Time frame: 48 weeks

Secondary Outcomes

Efficacy of DTG-based maintenance therapy (<50 copies/ml)

Proportion of patients maintaining HIV-RNA \<50 copies/ml throughout 48 weeks

Time frame: 48 weeks

Efficacy of DTG-based therapy (<50 copies/ml) by FDA snapshot analysis

Proportion of patients with HIV-RNA \< 50 cp/ml at week 48

Time frame: 48 weeks

HIV-RNA >100 copies/ml as time to loss of virological response (TLOVR)

defined as the first of the two-confirmed HIV-RNA \>100 copies/ml (at least two weeks apart)

Time frame: 48 weeks

Change in CD4 cell count

from baseline to week 48

Time frame: 48 weeks

Change in HIV-DNA

from baseline to week 48

Time frame: 48 weeks

Change in lipidic profile

from baseline to week 48

Time frame: 48 weeks

Data from ClinicalTrials.gov

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