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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

186 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-19

Study Completion Date

2019-05-20

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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HIV-1-infection Antiretroviral Therapy Maintenance Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

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%.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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

Group Type EXPERIMENTAL

Patient-centered monitoring

Intervention Type OTHER

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

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

Group Type EXPERIMENTAL

Switch to DTG + FTC

Intervention Type DRUG

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

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

Group Type EXPERIMENTAL

Switch to DTG + FTC

Intervention Type DRUG

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

Patient-centered monitoring

Intervention Type OTHER

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

Interventions

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Switch to DTG + FTC

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

Intervention Type DRUG

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

Intervention Type OTHER

Eligibility Criteria

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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;

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No