- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04788784
Patient-Reported Outcomes HIV BItherapy (PROBI)
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
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Martin Duracinsky, PhD
- Phone Number: 01 40 27 57 48
- Email: duracinsky.m@gmail.com
Study Locations
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-
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Le Kremlin-Bicêtre, France, 94275
- Recruiting
- Hopital de Bicetre
-
Contact:
- F
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Quimper, France, 29107
- Recruiting
- Centre Hospitalier de Cornouaille
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Contact:
- Jean-François Duthé
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Saint-Denis, France, 93200
- Recruiting
- Centre Hospitalier de Saint-Denis - Hôpital Delafontaine
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Contact:
- Awa NDiaye
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
Time Frame: Day 0, Month 1 and Month 6
|
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.
Time Frame: Day 0, Month 1 and Month 6
|
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)
Time Frame: Day 0, Month 1 and Month 6
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of the patient perception (Patient-Reported Outcomes - PRO) after the switch from HIV tritherapy to DOVATO dual therapy on the percieved HIV symptoms
Time Frame: Day 0, Month 1 and Month 6
|
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
|
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
Time Frame: Day 0, Month 1 and Month 6
|
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
|
Factors associated with high preference versus low preference for dual therapy
Time Frame: Day 0, Month 1 and Month 6
|
Describe the factors associated with high acceptability of Dovato regimen (acceptability scale)
|
Day 0, Month 1 and Month 6
|
Efficacy of the Dovato regimen through Week 24
Time Frame: Day 0, Month 1 and Month 6
|
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
|
Kinetic of CD4 through Week 24
Time Frame: Day 0, Month 1 and Month 6
|
Change From Baseline in Cluster of Differentiation (CD)4+ Cell Counts Over Time
|
Day 0, Month 1 and Month 6
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Martin Duracinsky, PhD, URC-ECO, AP-HP & UMR 1123, Université de Paris, Inserm
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Slow Virus Diseases
- HIV Infections
- Acquired Immunodeficiency Syndrome
Other Study ID Numbers
- PROBI
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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