Adherence to Dolutegravir and Outcome

HIV Clinical Trial

— DOLUTECAPS  

Official title:

Cohort Study to Assess Electronic-caps Defined Adherence Patterns - Virological Outcome Relationship Amongst HIV-1 Infected Subjects Receiving Dolutegravir-Based Antiretroviral Therapy)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02878642
• Other study ID #: 13-184
• Status: Recruiting
• Phase: N/A
• First received: May 27, 2016
• Last updated: January 31, 2017
• Start date: May 2015
• Est. completion date: December 2017

Study information

• Verified date: January 2017
• Source: University Hospital, Caen
• Contact: Jean Jacques PARIENTI, MD,PhD
• Phone: 02 31 06 43 20
• Email: parienti-jj[@]chu-caen.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV

Locations

Country	Name	City	State
France	Caen University Hospital	Caen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence to dolutegravir measured by the electronic pill boxes	Calculating the total compliance	From baseline up to week 24
Primary	Virologic Efficacy	Are defined as secondary virological failure condition patients to S24 a viral load above 40 copies / ml on 2 consecutive samples.	week 24
Secondary	Patient Genotype resistance if failure		Week 16 and 24