Adherence to Dolutegravir and Outcome
- Conditions
- HIV
- Registration Number
- NCT02878642
- Lead Sponsor
- University Hospital, Caen
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 120
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Virologic Efficacy week 24 Are defined as secondary virological failure condition patients to S24 a viral load above 40 copies / ml on 2 consecutive samples.
Adherence to dolutegravir measured by the electronic pill boxes From baseline up to week 24 Calculating the total compliance
- Secondary Outcome Measures
Name Time Method Patient Genotype resistance if failure Week 16 and 24
Trial Locations
- Locations (1)
Caen University Hospital
🇫🇷Caen, France