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Patient-Reported Outcomes HIV BItherapy

NCT ID: NCT04788784

Last Updated: 2021-04-30

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

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-12

Study Completion Date

2022-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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HIV/AIDS and Infections Patient Preference

Keywords

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HIV dual therapy Patient-reported Outcomes Health-Related Quality of Life

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ViiV Healthcare

INDUSTRY

Sponsor Role collaborator

University Paris 7 - Denis Diderot

OTHER

Sponsor Role lead

Responsible Party

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Dr Martin Duracinsky

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Martin Duracinsky, PhD

Role: PRINCIPAL_INVESTIGATOR

URC-ECO, AP-HP & UMR 1123, Université de Paris, Inserm

Locations

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Hôpital de Bicêtre

Le Kremlin-Bicêtre, , France

Site Status RECRUITING

Centre hospitalier de Cornouaille

Quimper, , France

Site Status RECRUITING

Centre Hospitalier de Saint-Denis - Hôpital Delafontaine

Saint-Denis, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Martin Duracinsky, PhD

Role: CONTACT

Phone: 01 40 27 57 48

Email: [email protected]

Facility Contacts

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Françoise Churaqui

Role: primary

F

Role: backup

Jean-François Duthé

Role: primary

Awa NDiaye

Role: primary

References

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Duracinsky M, Alain T, Zucman D, Rousset Torrente O, Brown Hajdukova E, Hocqueloux L, Allavena C, Marcellin F, Chassany O. Patient-reported outcomes among people living with HIV switching to dual therapy with dolutegravir/lamivudine: results from the PROBI study. Ther Adv Infect Dis. 2025 Oct 14;12:20499361251321728. doi: 10.1177/20499361251321728. eCollection 2025 Jan-Dec.

Reference Type DERIVED
PMID: 41112057 (View on PubMed)

Alain T, Marcellin F, Bessonneau P, Hocqueloux L, Muehlan H, Allavena C, Zucman D, Villalong-Olives E, Chassany O, Duracinsky M. Sex Differences in Patient-Reported Outcomes Among People Living With HIV Switching to an Oral Dual Therapy: Results From the PROBI Study. AIDS Res Treat. 2025 Oct 2;2025:1850783. doi: 10.1155/arat/1850783. eCollection 2025.

Reference Type DERIVED
PMID: 41078979 (View on PubMed)

Other Identifiers

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PROBI

Identifier Type: -

Identifier Source: org_study_id