Clinical trial NCT04788784: Patient-Reported Outcomes HIV BItherapy
Official title: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: HIV/AIDS and Infections
Patient Preference
Keywords: HIV dual therapy
Patient-reported Outcomes
Health-Related Quality of Life
Lead sponsor: University Paris 7 - Denis Diderot
Sponsor class: OTHER
Collaborators: name: ViiV Healthcare
First posted: 2021-03-09
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: Day 0, Month 1 and Month 6
measure: 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.
timeFrame: Day 0, Month 1 and Month 6
measure: 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)
timeFrame: Day 0, Month 1 and Month 6
Secondary outcomes:
measure: Change of the patient perception (Patient-Reported Outcomes - PRO) after the switch from HIV tritherapy to DOVATO dual therapy on the percieved HIV symptoms
timeFrame: Day 0, Month 1 and Month 6
measure: 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
timeFrame: Day 0, Month 1 and Month 6
measure: Factors associated with high preference versus low preference for dual therapy
timeFrame: Day 0, Month 1 and Month 6
measure: Efficacy of the Dovato regimen through Week 24
timeFrame: Day 0, Month 1 and Month 6
measure: Kinetic of CD4 through Week 24
timeFrame: Day 0, Month 1 and Month 6
Other outcomes:
Locations:
city: Le Kremlin-Bicêtre
country: France
facility: Hôpital de Bicêtre
city: Quimper
country: France
facility: Centre hospitalier de Cornouaille
city: Saint-Denis
country: France
facility: Centre Hospitalier de Saint-Denis - Hôpital Delafontaine
Study officials:
affiliation: URC-ECO, AP-HP & UMR 1123, Université de Paris, Inserm
name: Martin Duracinsky, PhD
role: PRINCIPAL_INVESTIGATOR
References: