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HIV/AIDS and InfectionsPROBINCT04788784

Patient-Reported Outcomes HIV BItherapy

An observational study of HIV/AIDS and Infections and Patient Preference, run by University Paris 7 - Denis Diderot at 3 sites in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV/AIDS and Infections, Patient Preference
How many people
250 participants
Where
3 sitesFrance
Study dates
12 Apr 2021to 31 Aug 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

3 sites in 1 country.

Martin Duracinsky, PhD contact

01 40 27 57 48

duracinsky.m@gmail.com

France3 sites, 3 recruiting

  • Hôpital de Bicêtre

    Le Kremlin-Bicêtre, 94275

    Françoise Churaqui, 0145217438 ext. 33, francoise.churaqui@aphp.fr

    F

    Recruiting

  • Centre hospitalier de Cornouaille

    Quimper, 29107

    Jean-François Duthé

    Recruiting

  • Centre Hospitalier de Saint-Denis - Hôpital Delafontaine

    Saint-Denis, 93200

    Awa NDiaye

    Recruiting

Other trials in France

About this study

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

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.

Keywords
HIV dual therapy, Patient-reported Outcomes, Health-Related Quality of Life
Medical subject headings
Acquired Immunodeficiency Syndrome, Infections, Patient Preference

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Day 0, Month 1 and Month 6

  2. 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.

    Measured: Day 0, Month 1 and Month 6

  3. 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.

    Measured: Day 0, Month 1 and Month 6

Secondary outcomes (5)

  1. 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.

    Measured: Day 0, Month 1 and Month 6

  2. 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

    Measured: Day 0, Month 1 and Month 6

  3. Factors associated with high preference versus low preference for dual therapy

    Describe the factors associated with high acceptability of Dovato regimen (acceptability scale)

    Measured: Day 0, Month 1 and Month 6

  4. 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

    Measured: Day 0, Month 1 and Month 6

  5. Kinetic of CD4 through Week 24

    Change From Baseline in Cluster of Differentiation (CD)4+ Cell Counts Over Time

    Measured: Day 0, Month 1 and Month 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Mar 2021
  2. Study start12 Apr 2021
  3. Primary completion1 May 2022 (estimated)
  4. Study completion31 Aug 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
250 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04788784
Sponsor's protocol ID
PROBI
Acronym
PROBI
Status last verified
Apr 2021
First submitted
2 Mar 2021
Last updated
30 Apr 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 41112057

  • Alain T, Marcellin F, Bessonneau P, Hocqueloux L, Muehlan H, Allavena C, Zucman D, Villalonga-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.

    PubMed 41078979

Questions about this trial

What is this clinical trial studying?

An observational study of HIV/AIDS and Infections and Patient Preference, run by University Paris 7 - Denis Diderot at 3 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 30 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Martin Duracinsky, PhD (01 40 27 57 48, duracinsky.m@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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. (time frame: Day 0, Month 1 and Month 6). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04788784, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2021.

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