DTG/3TC vs. BIC/FTC/TAF Maintenance Therapy in People Living With HIV:
PASO-DOBLE
1 other identifier
interventional
554
1 country
33
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jul 2021
Longer than P75 for phase_4
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 5, 2021
CompletedFirst Posted
Study publicly available on registry
May 12, 2021
CompletedStudy Start
First participant enrolled
July 14, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 20, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 13, 2025
CompletedJuly 18, 2025
July 1, 2025
2.6 years
May 5, 2021
July 17, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of patients with plasma HIV-1 RNA ≥50 copies/mL
Week 48
Secondary Outcomes (28)
Proportion of patients with plasma HIV-1 RNA ≥50 copies/mL
week 96
Proportion of patients with plasma HIV-1 RNA <50 copies/mL
Week 48 and week 96
Absolute weight
Basal, week 48 y week 96
BMI change
Basal, week 48 y week 96
Proportion of patients with weight change >5%
Basal, week 48 y week 96
- +23 more secondary outcomes
Study Arms (2)
Dovato arm
EXPERIMENTALDTG/3TC
Biktarvy arm
ACTIVE COMPARATORBIC/FTC/TAF
Interventions
\- Dose: Dolutegravir 50mg/ Lamivudine 300 mg -Route of adminstration: oral -Schedule of administration: once a day for 96 weeks.
* Dose: Bictegravir 50 mg/Emtricitabine 200 mg /Tenofovir alafenamide 25 mg * Route of adminstration: oral * Schedule of administration: once a day for 96 weeks.
Eligibility Criteria
You may qualify if:
- 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.
- 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.
You may not qualify if:
- 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.
- 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).
- Previous or current therapy with dolutegravir or bictegravir.
- History of allergy to study drugs or their components.
- Liver disease as defined by ALT \>= 5x ULN or ALT \>=3xULN and Bili =1.5xULN (with \>35% direct bilirubin).
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fundacion SEIMC-GESIDAlead
- ViiV Healthcarecollaborator
Study Sites (33)
H. Marina Baixa
Villajoyosa, Alicante, 03570, Spain
Hospital Fundación Alcorcón
Alcorcón, Madrid, 28922, Spain
CHUAC
A Coruña, Spain
H. General Universitario Dr. Balmis
Alicante, 03010, Spain
H. de Elche
Alicante, Spain
H. de Torrecárdenas
Almería, Spain
H. Clinic
Barcelona, 08036, Spain
H. Germans Trias i Pujol
Barcelona, 08916, Spain
H. de Bellvitge
Barcelona, Spain
H. de Igualada
Barcelona, Spain
H. del Mar
Barcelona, Spain
H. San Joan de Deu
Barcelona, Spain
H. Sant Creu y Sant Pau
Barcelona, Spain
H. Vall de Hebron
Barcelona, Spain
H. Universitario de Guadalajara
Guadalajara, 19002, Spain
H. Juan Ramón Jimenez
Huelva, Spain
Hospital Universitari Arnau de Vilanova
Lleida, 25198, Spain
H. Infanta Leonor
Madrid, Spain
H. La Princesa
Madrid, Spain
H. Príncipe de Asturias
Madrid, Spain
H. Univ. La Paz
Madrid, Spain
H. Univ. Puerta de Hierro
Madrid, Spain
H. Costa del Sol
Marbella, Spain
H. Reina Sofía
Murcia, Spain
H. Central de Asturias
Oviedo, Spain
H. Son Espases
Palma de Mallorca, Spain
H. Son Llatzer
Palma de Mallorca, Spain
H. de Valme
Seville, Spain
H. Joan XXIII
Tarragona, Spain
H. Clínico Univ. de Valencia
Valencia, Spain
H Clinico Univ. de Valladolid
Valladolid, Spain
H. Alvaro Cunquerio
Vigo, Spain
H. Clinico Univ. Lozano Bleza
Zaragoza, Spain
Related Publications (1)
Ryan P, Blanco JL, Masia M, Garcia-Fraile L, Crusells MJ, Domingo P, Curran A, Guerri-Fernandez R, Bernal E, Bravo J, Revollo B, Macias J, Tiraboschi JM, Montejano R, Amador C, Torralba M, Merino D, Diaz-Brito V, Galindo MJ, Ferra S, Villoslada A, Losa JE, Fanjul FJ, Perez-Stachowski X, Peraire J, Portilla J, de la Fuente S, Duenas C, Vazquez MJ, Di Gregorio S, Esteban H, Gil P, de Miguel M, Alejos B, Martinez E; PASO-DOBLE study group. Maintenance therapy with dolutegravir and lamivudine versus bictegravir, emtricitabine, and tenofovir alafenamide in people with HIV (PASO-DOBLE): 48-week results from a randomised, multicentre, open-label, non-inferiority trial. Lancet HIV. 2025 Jul;12(7):e473-e484. doi: 10.1016/S2352-3018(25)00105-5. Epub 2025 Jun 7.
PMID: 40489982DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Esteban Martinez, MD
H. Clinc de Barcelona
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 5, 2021
First Posted
May 12, 2021
Study Start
July 14, 2021
Primary Completion
February 20, 2024
Study Completion
March 13, 2025
Last Updated
July 18, 2025
Record last verified: 2025-07