An observational study in HIV/AIDS and Infections and Patient Preference, sponsored by University Paris 7 - Denis Diderot. Status unknown at 3 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-04-30.
Sponsored by University Paris 7 - Denis Diderot · Observational
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.
3,035 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 306 are open to participants now.
This study's planned enrollment of 250 is below the median of 287 across 503 observational studies indexed under Acquired Immunodeficiency Syndrome.
Browse Acquired Immunodeficiency Syndrome studies →University Paris 7 - Denis Diderot is the lead sponsor of 13 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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 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.
Time frame: 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
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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: Day 0, Month 1 and Month 6
Plan to share: No
No publications or documents are linked to this record.
Started Apr 2021 (actual). Primary completion is estimated for May 2022, 12 months after the start.
Of 165 non-industry observational studies under Acquired Immunodeficiency Syndrome, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 83. This study's planned 12 months is below that.
Counting every sponsor, half of 177 studies reached it within 44 months; a quarter within 19 and three quarters within 79.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Acquired Immunodeficiency Syndrome →
University Paris 7 - Denis Diderot