Patient-Reported Outcomes HIV BItherapy (PROBI)

April 27, 2021 updated by: Dr Martin Duracinsky, University Paris 7 - Denis Diderot

Mixed-method Study to Evaluate Acceptability, Perceived Toxicity, Preference and Health-related Quality of Life Among HIV Patients Switching to a Dual Therapy Such as the Dovato Regimen

HIV Treatment simplification strategies that involve switching cART regimens from four or three antiretrovirals to two in virologically suppressed patients living with HIV are now available in order to reduce long-term toxicity and enhance treatment adherence. Dolutegravir is a second-generation integrase strand transfer inhibitor (INSTI) with noticeable advantages, including a high genetic barrier to drug resistance, once-daily dosing and lower risk of drug-drug interactions because this agent does not inhibit or induce cytochrome P450 isoenzymes or P-glycoprotein transporters. Dolutegravir is generally well tolerated and the INSTI class is considered to be more "metabolically friendly" compared with other drug classes such as protease inhibitors (PIs). Thus, the combination of dolutegravir plus a second active agent is a particularly inviting option for maintenance treatment and research in this area is evolving. However, though safety and efficacy of dolutegravir are well known, there is no study evaluating patient-reported outcomes (PROs), i.e. subjective and self-reported measures of the patient's health perception. In an era of the efficacy of HIV regimens are more and more comparable, the main discriminant criteria to choose the best treatment option are now adherence and self-reported measures of a patient's health - termed "patient-reported outcomes" (PROs).

The study, based on a mixed methodology, include a qualitative part and a quantitative part. The qualitative study will explore patients' and health care professionals' perceptions, knowledge, and representations of triple or quadruple and dual therapies and detect the degree of agreement or disagreement between patients' and practitioners' perspectives. The quantitative study's main objective is to measure the Dovato regimen's impact on a patient's perception (Patient-Reported Outcomes - PRO) on acceptability, toxicity, preference, and Health-Related Quality of Life (HRQL). PRO are collected through self-administered questionnaires at D0 (when the patient switch treatment), M1 and M6.

Study Overview

Status

Recruiting

Study Type

Observational

Enrollment (Anticipated)

250

Contacts and Locations

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

Study Contact

Study Locations

      • Le Kremlin-Bicêtre, France, 94275
        • Recruiting
        • Hopital de Bicetre
        • Contact:
          • F
      • Quimper, France, 29107
        • Recruiting
        • Centre Hospitalier de Cornouaille
        • Contact:
          • Jean-François Duthé
      • Saint-Denis, France, 93200
        • Recruiting
        • Centre Hospitalier de Saint-Denis - Hôpital Delafontaine
        • Contact:
          • Awa NDiaye

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

HIV-1 patients who are prescribed a Dovato regimen by their clinicians in routine care for any reason. The patient must be able to read in order to fill up the questionnaires.

Description

Inclusion Criteria:

  • Patients infected by HIV-1
  • Patients who are prescribed the Dovato regimen by their clinicians in routine care
  • Patients previously under the cART regimen with three or four antiretrovirals
  • HIV-RNA <=50 copies/mL for at least 3 months
  • 18 years old and more
  • Ability to understand and respond to questionnaires

Exclusion Criteria:

  • Pregnant or breastfeeding women
  • Known hypersensitivity to dolutegravir and lamivudine, their metabolites or formulation excipient
  • Active, serious infection (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to inclusion
  • Any other clinical condition or prior therapy that, in the investigator's opinion, would make the subject unsuitable for the study, or unable to comply with protocol requirements.
  • Active CDC Category C disease
  • Treatment with radiation therapy, cytotoxic chemotherapeutic agents 30 days before inclusion
  • Patient co-infected with HBV

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
Change of the patient perception (Patient-Reported Outcomes - PRO) after a switch from HIV tritherapy to DOVATO dual therapy on the perceived toxicity of the treatment.
Time Frame: Day 0, Month 1 and Month 6
A score of perceived toxicity and preference: measured by the scale developed during a previous qualitative step of the study (PTP scale) on the day of the switch, 1 month after the switch and 6 month after the switch.
Day 0, Month 1 and Month 6
Change of the patient perception (Patient-Reported Outcomes - PRO) after a switch from HIV tritherapy to DOVATO dual therapy on the acceptability of the treatment.
Time Frame: Day 0, Month 1 and Month 6
A score of acceptability (at baseline only): measured by the scale developed during a previous qualitative step of the study (Acceptability scale) on the day of the switch, 1 month after the switch and 6 month after the switch.
Day 0, Month 1 and Month 6
Change of the patient perception (Patient-Reported Outcomes - PRO) after the switch from HIV tritherapy to DOVATO dual therapy on Health-Related Quality of Life (HRQL)
Time Frame: Day 0, Month 1 and Month 6
The treatment impact (TI, 10) dimension of the PROQOL-HIV questionnaire will measure HRQL on the day of the switch, 1 month after the switch and 6 month after the switch.
Day 0, Month 1 and Month 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of the patient perception (Patient-Reported Outcomes - PRO) after the switch from HIV tritherapy to DOVATO dual therapy on the percieved HIV symptoms
Time Frame: Day 0, Month 1 and Month 6
HIV Symptom Index, a 20 items index on different symptoms experienced by HIV patients on the day of the switch, 1 month after the switch and 6 month after the switch.
Day 0, Month 1 and Month 6
Change of the patient perception (Patient-Reported Outcomes - PRO) after the switch from HIV tritherapy to DOVATO dual therapy on adherence with the dual therapy
Time Frame: Day 0, Month 1 and Month 6
Adherence ANRS (Agence nationale de recherches sur le sida et les hépatites virales - French agency for AIDS and viral hepatitis research) questionnaire of 3 items
Day 0, Month 1 and Month 6
Factors associated with high preference versus low preference for dual therapy
Time Frame: Day 0, Month 1 and Month 6
Describe the factors associated with high acceptability of Dovato regimen (acceptability scale)
Day 0, Month 1 and Month 6
Efficacy of the Dovato regimen through Week 24
Time Frame: Day 0, Month 1 and Month 6
Percentage of Participants With Human Immunodeficiency Virus-1 (HIV-1) RNA <50 Copies (c)/Millilitre (mL) Through Week 24
Day 0, Month 1 and Month 6
Kinetic of CD4 through Week 24
Time Frame: Day 0, Month 1 and Month 6
Change From Baseline in Cluster of Differentiation (CD)4+ Cell Counts Over Time
Day 0, Month 1 and Month 6

Collaborators and Investigators

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

Collaborators

Investigators

  • Principal Investigator: Martin Duracinsky, PhD, URC-ECO, AP-HP & UMR 1123, Université de Paris, Inserm

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)

April 12, 2021

Primary Completion (Anticipated)

May 1, 2022

Study Completion (Anticipated)

August 31, 2022

Study Registration Dates

First Submitted

March 2, 2021

First Submitted That Met QC Criteria

March 4, 2021

First Posted (Actual)

March 9, 2021

Study Record Updates

Last Update Posted (Actual)

April 30, 2021

Last Update Submitted That Met QC Criteria

April 27, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

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.

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