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NCT04884139CompletedPhase 4

DTG/3TC vs. BIC/FTC/TAF Maintenance Therapy in People Living With HIV:

DTG/3TC vs. BIC/FTC/TAF Maintenance Therapy in People Living With HIV: an Open-label Randomized Clinical Trial

Source: ClinicalTrials.gov · Last updated 18 Jul 2025

Brief summary (registry, in English)

The hypothesize that DTG/3TC will be non-inferior to BIC/FTC/TAF with a 4% margin in virologically suppressed HIV-infected patients. The study will allow claiming for Superiority. Assuming that both DTG and BIC may lead to similar weight gains (approximately 1 kg after 48 weeks) in virologically suppressed HIV-infected patients and that TAF may induce a further weight gain (approximately 1 kg after 48 weeks), also hypothesize that switching to BIC/FTC/TAF may lead to greater weight gain than switching to DTG/3TC over 48 weeks. This trial is a Phase IV, open-label, randomized multicentre clinical trial evaluating the efficacy of DTG/3TC versus BIC/FTC/TAF for the maintenance of virological suppression in HIV patients.

Status (registry)
Completed
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
554 (actual)
First submitted
5 May 2021
Start date
14 Jul 2021
Primary completion date
20 Feb 2024
Lead sponsor
Fundacion SEIMC-GESIDA
Diseases
HIV
NCT number
NCT04884139
EU CT number
2024-515167-56-00
EudraCT number
2020-003686-18

What you commit to

  • Study type: Interventional · Phase 4
  • Participants enrolled: 554
  • From 14 Jul 2021 to the primary completion date, 20 Feb 2024
  • 30 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous or current therapy with dolutegravir or bictegravir.
  • Any recently (\<=6 months) diagnosed clinical condition or recently (\<=6 months) initiated concomitant therapy (see Section 6.5) that may primarily affect weight or body composition. E.g., including but not limited to endocrine disorders, osteoporosis or medications to treat these clinical conditions, with the exception of ontrolled diabetes mellitus.

Other illness

  • Evidence of Hepatitis B virus infection based on at least one positive result of testing at Screening for Hepatitis B surface antigen (HBsAg) and Hepatitis B core antibody (anti- HBc).
  • History of allergy to study drugs or their components.
  • Unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice), cirrhosis, known biliary abnormalities (apart from hyperbilirubinemia or jaundice due to Gilbert\'s syndrome or asymptomatic gallstones);
  • Subjects with severe hepatic impairment (Class C) as determined by Child-Pugh classification and/or anticipated need for Hep C treatment.
  • Kidney disease as defined by CKD-EPI \<50ml/min.

Lab values

  • Liver disease as defined by ALT \>= 5x ULN or ALT \>=3xULN and Bili =1.5xULN (with \>35% direct bilirubin).

Other

  • Is pregnant or lactating at the screening visit or at any time during the study or is planning on becoming pregnant over the duration of the study.

Who the study is looking for

  • Understanding the study information provided and being capable of giving written informed consent.
  • Confirmed HIV infection.
  • ≥18 years of age on the day of screening.
  • HIV RNA \<50 copies/mL for at least 24 weeks before screening.
  • Receiving any regimen for HIV containing more than 1 pill a day or any single tablet regimen containing at least one of the following: cobicistat-boosting, efavirenz, or tenofovir disoproxyl fumarate, for at least 24 weeks before screeningPatients with TAF are expected from cobiscitat-boosting single tablet regimens containing darunavir or elvitegravir and from more-than-1-pill-a-day regimens containing TAF/FTC; their participation will be limited to ≤25%. Patients will be stratified according to the presence or not of TAF in their regimens.
  • No evidence of previous viral failure.
  • No known or suspected resistance to study drugs.
  • Females of childbearing potential, must be using highly effective methods of contraception from study inclusion and for at least 4 weeks after last study visit; all female volunteers must be willing to undergo urine pregnancy testing at the time points specified in the schedules of events.
  • Clinical stability: Participants who are healthy (other than HIV infection) as determined by the Investigator or medically qualified designee based on a medical evaluation including medical history, laboratory tests, and cardiac monitoring.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (30)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Complexo Hospitalario Universitario A Coruña
Coordinator of this site? Confirm its status
A CoruñaSpainCompleted
Hospital Universitario Fundación Alcorcón
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AlcorcónSpainCompleted
Hospital General Universitario Dr. Balmis
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AlicanteSpainCompleted
Hospital Universitario Torrecárdenas
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AlmeríaSpainCompleted
Hospital Germans Trias i Pujol
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BadalonaSpainCompleted
Hospital Clinic de Barcelona
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BarcelonaSpainCompleted
Hospital del Mar
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BarcelonaSpainCompleted
Hospital Universitari Vall d'Hebron
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BarcelonaSpainCompleted
Hospital de la Santa Creu i Sant Pau
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BarcelonaSpainCompleted
Hospital General Universitario de Elche
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ElcheSpainCompleted
Hospital Universitario De Guadalajara SESCAM
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GuadalajaraSpainCompleted
Hospital Universitario Juan Ramon Jimenez
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HuelvaSpainCompleted
Bellvitge University Hospital
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L'hospitalet De LlobregatSpainCompleted
Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida
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LleidaSpainCompleted
Hospital Universitario de la Princesa
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MadridSpainCompleted
Hospital Universitario Infanta Leonor
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MadridSpainCompleted
Hospital Universitario Puerta de Hierro de Majadahonda
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MadridSpainCompleted
Hospital Universitario La Paz
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MadridSpainCompleted
Hospital Costa del Sol
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MarbellaSpainCompleted
Hospital Universitario Reina Sofía de Murcia
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MurciaSpainCompleted
Hospital Son Llatzer
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PalmaSpainCompleted
University Hospital Son Espases
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PalmaSpainCompleted
Parc Sanitari Sant Joan de Déu
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Sant Boi de LlobregatSpainCompleted
Hospital Universitario Virgen De Valme
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SevillaSpainCompleted
Hospital Universitari Joan XXIII de Tarragona
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TarragonaSpainCompleted
Hospital Clínico de Valencia
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ValenciaSpainCompleted
Hospital Clínico Universitario de Valladolid
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ValladolidSpainCompleted
Hospital Alvaro Cunqueiro
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VigoSpainCompleted
Hospital Marina Baixa De La Vila Joiosa
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VillajoyosaSpainCompleted
Hospital Clinico Universitario Lozano Blesa
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ZaragozaSpainCompleted

This page is information, not medical advice. Discuss any trial with your doctor.