Adherence to Dolutegravir and Outcome

University Hospital, Caen120 enrolled

Overview

The main assumption is that the dolutegravir can get virologic suppression to suboptimal adherence levels (between 80 and 95%, and after treatment interruptions) where other molecules are not capable, due to their pharmacokinetic/pharmacodynamic (pardonnance). While the investigators goal is not to compare molecules (study with one arm) in terms of forgiveness, the results of this cohort in terms of forgiveness could be compared to other cohorts available.

Study Type

OBSERVATIONAL

Enrollment

120

Conditions

HIV

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * HIV-1 * Age over 18 years * Information letter signed * ART (antiretroviral therapy) with at least 3 active molecules * Patients starting treatment with dolutegravir (naïve to antiretroviral treatment, switch, virologic failure) Exclusion Criteria: * pregnant woman * HIV-2 * Patient does not have responsibility for the observance of treatment (disorder of judgment, guardianship, institutionalization) * Patient receiving aid incompatible with compliance with the use of electronic pillbox

Locations (1)

Caen University Hospital

Caen, France

RECRUITING

Outcomes

Primary Outcomes

Adherence to dolutegravir measured by the electronic pill boxes

Calculating the total compliance

Time frame: From baseline up to week 24

Virologic Efficacy

Are defined as secondary virological failure condition patients to S24 a viral load above 40 copies / ml on 2 consecutive samples.

Time frame: week 24

Secondary Outcomes

Patient Genotype resistance if failure

Time frame: Week 16 and 24

Central Contacts

Jean Jacques PARIENTI, MD,PhD

CONTACT

02 31 06 43 20 parienti-jj@chu-caen.fr

Data from ClinicalTrials.gov

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