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| Name | Class |
|---|---|
| ViiV Healthcare | INDUSTRY |
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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.
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| 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. | 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. | 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) | 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 |
| 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 | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Martin Duracinsky, PhD | Contact | 01 40 27 57 48 | duracinsky.m@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Martin Duracinsky, PhD | URC-ECO, AP-HP & UMR 1123, Université de Paris, Inserm | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital de Bicêtre | Recruiting | Le Kremlin-Bicêtre | 94275 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41112057 | Derived | 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. | |
| 41078979 |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D007239 | Infections |
| D057240 | Patient Preference |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D015229 | Sexually Transmitted Diseases, Viral |
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| 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 |
| 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 |
| 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 |
| 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 |
| Centre hospitalier de Cornouaille | Recruiting | Quimper | 29107 | France |
|
| Centre Hospitalier de Saint-Denis - Hôpital Delafontaine | Recruiting | Saint-Denis | 93200 | France |
|
| Derived |
| 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. |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D017060 | Patient Satisfaction |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |