Adherence to Dolutegravir and Outcome

NCT ID: NCT02878642

Last Updated: 2017-02-01

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

UNKNOWN

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-05-31

Study Completion Date

2017-12-31

Brief Summary

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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

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Conditions

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HIV

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Caen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Caen University Hospital

Caen, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Jean Jacques PARIENTI, MD,PhD

Role: CONTACT

02 31 06 43 20 ext. +33

Facility Contacts

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Jean Jacques PARIENTI, MD, PhD

Role: primary

Other Identifiers

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13-184

Identifier Type: -

Identifier Source: org_study_id

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