63
Participants
Start Date
May 26, 2023
Primary Completion Date
July 7, 2025
Study Completion Date
July 7, 2025
Dolutegravir (DTG) 50 mg/day + Rilpivirine (RPV) 25mg per day
DTG/RPV will be administered in combination as 50/25 mg/day tablets or separately as DTG 50 mg/d tablets together with RPV 25 mg/d tablets. There will be no problem if during the course of the study the patient is switched from the combined form to the separate form and vice versa as long as the HAART (Highly Active Antiretroviral Therapy) components are respected.
Tenofovir disoproxil fumarate (TDF) 245 mg per day or Tenofovir alafenamide (TAF) 25 mg per day + Emtricitabine (FTC) 200 mg per day + Rilpivirine 25 mg per day
TDF 245 mg/d or TAF 25mg/d together with FTC 200 mg/d and RPV 25 mg/d. They may be administered as single tablets or in combination forms where one tablet contains TDF/TAF and FTC and another RPV tablet. There will be no problem if during the course of the study the patient is switched from the combined form to the separate form and vice versa as long as the HAART components are respected.
Continue with their previous treatment. Any previous HAART that does not contain Rilpivirine.
Patients who are randomised to this treatment arm will continue with the HAART they were receiving prior to signing the informed consent. As in arms 1 and 2, a change in the form of HAART administration (from a combined to a separate form and vice versa) will be allowed as long as the HAART components are respected.
Hospital Universitario Gregorio Marañon, Madrid
Hospital universitario Infanta Leonor, Madrid
Hospital Universitario Infanta Sofía, Madrid
Hospital Universitario La Paz, Madrid
Fundacion SEIMC-GESIDA
OTHER