Patient-Reported Outcomes HIV BItherapy

Patient Preference Clinical Trial

— PROBI  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04788784
• Other study ID #: PROBI
• Status: Recruiting
• Start date: April 12, 2021
• Est. completion date: August 31, 2022

Study information

• Verified date: April 2021
• Source: University Paris 7 - Denis Diderot
• Contact: Martin Duracinsky, PhD
• Phone: 01 40 27 57 48
• Email: duracinsky.m[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: August 31, 2022
• Est. primary completion date: May 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• HIV/AIDS and Infections
• Patient Preference

Locations

Country	Name	City	State
France	Hôpital de Bicêtre	Le Kremlin-Bicêtre
France	Centre hospitalier de Cornouaille	Quimper
France	Centre Hospitalier de Saint-Denis - Hôpital Delafontaine	Saint-Denis

Sponsors (2)

Lead Sponsor	Collaborator
University Paris 7 - Denis Diderot	ViiV Healthcare

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Change of the patient perception (Patient-Reported Outcomes - PRO) after the switch from HIV tritherapy to DOVATO dual therapy on the percieved HIV symptoms	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
Secondary	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	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
Secondary	Factors associated with high preference versus low preference for dual therapy	Describe the factors associated with high acceptability of Dovato regimen (acceptability scale)	Day 0, Month 1 and Month 6
Secondary	Efficacy of the Dovato regimen through Week 24	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
Secondary	Kinetic of CD4 through Week 24	Change From Baseline in Cluster of Differentiation (CD)4+ Cell Counts Over Time	Day 0, Month 1 and Month 6