Patient-Reported Outcomes HIV BItherapy

NCT04788784 | Unknown

• 1 other identifier: PROBI
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

HIV/AIDS and Infections; Patient Preference

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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)

  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 Outcomes (5)

• Change of the patient perception (Patient-Reported Outcomes - PRO) after the switch from HIV tritherapy to DOVATO dual therapy on the percieved HIV symptoms

  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

  Day 0, Month 1 and Month 6

• Factors associated with high preference versus low preference for dual therapy

  Day 0, Month 1 and Month 6

• Efficacy of the Dovato regimen through Week 24

  Day 0, Month 1 and Month 6

• Kinetic of CD4 through Week 24

  Day 0, Month 1 and Month 6

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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
• years old and more
• Ability to understand and respond to questionnaires

You may not qualify if:

• Pregnant or breastfeeding women
• Known hypersensitivity to dolutegravir and lamivudine, their metabolites or formulation excipient
• 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
• Patient co-infected with HBV

Sponsors & Collaborators

• University Paris 7 - Denis Diderot: lead
• ViiV Healthcare: collaborator

Study Sites (3)

Hôpital de Bicêtre

Le Kremlin-Bicêtre, 94275, France

RECRUITING

Centre hospitalier de Cornouaille

Quimper, 29107, France

RECRUITING

Centre Hospitalier de Saint-Denis - Hôpital Delafontaine

Saint-Denis, 93200, France

RECRUITING

Related Publications (2)

• 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.

  PMID: 41112057 DERIVED

• 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.

  PMID: 41078979 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Infections; Patient Preference

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Patient Satisfaction; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Martin Duracinsky, PhD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Martin Duracinsky, PhD

CONTACT

01 40 27 57 48; duracinsky.m@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: March 2, 2021
• First Posted: March 9, 2021
• Study Start: April 12, 2021
• Primary Completion: May 1, 2022
• Study Completion: August 31, 2022
• Last Updated: April 30, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)