Patient-Reported Outcomes HIV BItherapy (PROBI)

Paris Diderot University

Status: Unknown

Conditions: Patient Preference; HIV/AIDS and Infections

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04788784

PROBI

Details and patient eligibility

About

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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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