NCT02878642

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 27, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 25, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

February 1, 2017

Status Verified

January 1, 2017

Enrollment Period

2.6 years

First QC Date

May 27, 2016

Last Update Submit

January 31, 2017

Conditions

HIV

Outcome Measures

Primary Outcomes (2)

  • Adherence to dolutegravir measured by the electronic pill boxes

    Calculating the total compliance

    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.

    week 24

Secondary Outcomes (1)

  • Patient Genotype resistance if failure

    Week 16 and 24

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients infected with HIV-1 treated with dolutegravir at week 16 and week 24

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Caen University Hospital

Caen, 14000, France

RECRUITING

Central Study Contacts

Jean Jacques PARIENTI, MD,PhD

CONTACT

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2016

First Posted

August 25, 2016

Study Start

May 1, 2015

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

February 1, 2017

Record last verified: 2017-01

Locations

FR(1)