Duration of Dual Antiretroviral Therapy in Virologically Suppressed People Living With HIV and Factors Associated With Switching to Tritherapy : a Real-life Cohort (TOBIT)

October 30, 2023 updated by: Tourcoing Hospital
HIV infection requires lifelong continuous antiretroviral (ARV) treatment. The efficacy of current ARV treatments makes it possible to propose strategies for reducing the cumulative exposure to ARVs, side effects and costs. And so improve the quality of life of people living with HIV (PLHIV). However, in the real world, less regular adherence to treatment, more heavily pre-treated patients and resistance to treatment make these dual therapies prescribed beyond the strict framework of clinical trials. This can lead to undesirable side effects. From the perspective of personalized medicine, it seems to be important to determine which patients are receiving dual ARV therapy, and which patients remain on it for a long time. Identifying prognostic factors would enable us to adapt therapeutic management.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

580

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Tourcoing, France, 59208
        • Centre Hospitalier DRON

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients followed up in a referral center for the management of PLHIV who started dual antiretroviral therapy in the period from 2011 to 2023 and whose viral load was < 50 copies/ml before initiation of dual therapy.

Description

Inclusion Criteria:

  • hiv patient
  • viral load < 50copies/ml
  • patient treated with dual therapy
  • patients with hospital follow-up between 2011 and 2023

Exclusion Criteria:

  • adults under legal protection
  • underage

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
therapeutic switch
Time Frame: 5 years
Proportion of patients switching from dual to triple therapy
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tourcoing Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2011

Primary Completion (Actual)

May 1, 2023

Study Completion (Actual)

May 1, 2023

Study Registration Dates

First Submitted

October 24, 2023

First Submitted That Met QC Criteria

October 24, 2023

First Posted (Actual)

October 30, 2023

Study Record Updates

Last Update Posted (Actual)

November 1, 2023

Last Update Submitted That Met QC Criteria

October 30, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHT/URC/2023/13

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on HIV Infections

Clinical Trials on dual therapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United Arab Emirates

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe