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HIV-1-infectionPhase 4PASO-DOBLENCT04884139

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

A Phase 4 study testing Dolutegravir/Lamivudine as a single pill and Bictegravir/Emtricitabine/Tenofovir alfenamide as a single pill. in people with HIV-1-infection, run by Fundacion SEIMC-GESIDA at 33 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV-1-infection
What is being tested?
Dolutegravir/Lamivudine as a single pill and Bictegravir/Emtricitabine/Tenofovir alfenamide as a single pill.
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
554 participants
Where
33 sitesSpain
Study dates
14 Jul 2021to 13 Mar 2025
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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);
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  • 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.

Trial locations and contacts

33 sites in 1 country.

33 sites in 1 country

Spain33 sites

  • CHUAC

    A Coruña

  • Hospital Fundación Alcorcón

    Alcorcón, Madrid, 28922

  • H. General Universitario Dr. Balmis

    Alicante, 03010

  • H. de Elche

    Alicante

  • H. de Torrecárdenas

    Almería

  • H. Clinic

    Barcelona, 08036

  • H. Germans Trias i Pujol

    Barcelona, 08916

  • H. de Bellvitge

    Barcelona

  • H. de Igualada

    Barcelona

  • H. del Mar

    Barcelona

  • H. San Joan de Deu

    Barcelona

  • H. Sant Creu y Sant Pau

    Barcelona

  • H. Vall de Hebron

    Barcelona

  • H. Universitario de Guadalajara

    Guadalajara, 19002

  • H. Juan Ramón Jimenez

    Huelva

  • Hospital Universitari Arnau de Vilanova

    Lleida, 25198

  • H. Infanta Leonor

    Madrid

  • H. La Princesa

    Madrid

  • H. Príncipe de Asturias

    Madrid

  • H. Univ. La Paz

    Madrid

  • H. Univ. Puerta de Hierro

    Madrid

  • H. Costa del Sol

    Marbella

  • H. Reina Sofía

    Murcia

  • H. Central de Asturias

    Oviedo

  • H. Son Espases

    Palma de Mallorca

  • H. Son Llatzer

    Palma de Mallorca

  • H. de Valme

    Seville

  • H. Joan XXIII

    Tarragona

  • H. Clínico Univ. de Valencia

    Valencia

  • H Clinico Univ. de Valladolid

    Valladolid

  • H. Alvaro Cunquerio

    Vigo

  • H. Marina Baixa

    Villajoyosa, Alicante, 03570

  • H. Clinico Univ. Lozano Bleza

    Zaragoza

Other trials in Spain

About this study

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

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.

Read the detailed description

Participants will be randomly assigned in a 1:1 ratio to receive DTG/3TC or BIC/FTC/TAF. Randomization will be stratified by sex and TAF use at baseline. At least 33% of the patients included will be women.

The investigator will also endeavour to recruit as many non-Caucasian participants as possible.

Patients with TAF-containing regimens at baseline will be limited to 25% or less of the total number of participants.

Three sub-studies will be performed: Omics sub-study ; Senescence sub-study; Fat biopsies sub-study.

Omics sub-study: Assess the mechanistic pathways involved on weight changes associated with switching to BIC/FTC/TAF vs. DTG/3TC.

Senescence sub-study: Assess the potential effects on the telomere length, epigenetic age and oxidative stress markers of switching to BIC/FTC/TAF vs. DTG/3TC.

Fat biopsies sub-study: To assess potential effects of switching to BIC/FTC/TAF vs.

DTG/3TC on expression of marker genes of mitochondrial function, adipogenesis, and inflammation in subcutaneous fat tissue. Assays on adipose tissue gene expression will be complemented by analysis in serum of adipokines representative of adipose tissue function (leptin, adiponectin), and inflammation biomarkers (TNFalpha, MCP-1, IL-6, IL-8, IL-10, IL-18).

Conditions
HIV-1-infection
Being tested
Dolutegravir/Lamivudine as a single pill, Bictegravir/Emtricitabine/Tenofovir alfenamide as a single pill.

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dolutegravir/Lamivudine as a single pillDrug

    • Dose: Dolutegravir 50mg/ Lamivudine 300 mg -Route of adminstration: oral -Schedule of administration: once a day for 96 weeks.

  • Bictegravir/Emtricitabine/Tenofovir alfenamide as a single pill.Drug

    • Dose: Bictegravir 50 mg/Emtricitabine 200 mg /Tenofovir alafenamide 25 mg
    • Route of adminstration: oral
    • Schedule of administration: once a day for 96 weeks.
Study groups in NCT04884139
Study groupRoleWhat they receive
Dovato armExperimentalDTG/3TC
Receives: Drug: Dolutegravir/Lamivudine as a single pill
Biktarvy armActive comparatorBIC/FTC/TAF
Receives: Drug: Bictegravir/Emtricitabine/Tenofovir alfenamide as a single pill.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of patients with plasma HIV-1 RNA ≥50 copies/mL

    Measured: Week 48

Secondary outcomes (28)

  1. Proportion of patients with plasma HIV-1 RNA ≥50 copies/mL

    Measured: week 96

  2. Proportion of patients with plasma HIV-1 RNA <50 copies/mL

    Measured: Week 48 and week 96

  3. Absolute weight

    Measured: Basal, week 48 y week 96

  4. BMI change

    Measured: Basal, week 48 y week 96

  5. Proportion of patients with weight change >5%

    Measured: Basal, week 48 y week 96

  6. Absolute values in CD4+ cells count

    Measured: Basal, week 48 y week 96

  7. Changes in CD4+ cells count

    Measured: Basal, week 48 y week 96

  8. Absolute values CD4:CD8 ratio

    Measured: Basal, week 48 y week 96

  9. Changes CD4:CD8 ratio

    Measured: Basal, week 48 y week 96

  10. Change in total and regional (trunk and extremities) fat by DXA

    Measured: Basal, week 48 y week 96

  11. Change in total and regional (trunk and extremities) fat-free mass by DXA

    Measured: Basal, week 48 y week 96

  12. Change in lumbar and hip bone mineral density (BMD) by DXA

    Measured: Basal, week 48 y week 96

  13. Change trabecular bone score (TBS) by DXA

    Measured: Basal, week 48 y week 96

  14. Change in subcutaneous and visceral fat (CT)

    Measured: Basal, week 48 y week 96

  15. Change in fasting glucose cholesterol, triglycerides), and FIB-4 score

    Measured: Basal, week 48 y week 96

  16. Change insulin cholesterol, triglycerides), and FIB-4 score

    Measured: Basal, week 48 y week 96

  17. Change in HOMA-IR cholesterol, triglycerides), and FIB-4 score

    Measured: Basal, week 48 y week 96

  18. Change in HbA1c cholesterol, triglycerides), and FIB-4 score

    Measured: Basal, week 48 y week 96

  19. Change in plasma lipids (total, HDL, and LDL) cholesterol, triglycerides), and FIB-4 score

    Measured: Basal, week 48 y week 96

  20. Changes in estimated glomerular filtration rate (CKD-EPI)

    Measured: Basal, week 48 y week 96

  21. Changes in urinary protein/creatinine

    Measured: Basal, week 48 y week 96

  22. Change in blood pressure

    Systolic and Diastolic Blood Pressure

    Measured: Basal, week 48 y week 96

  23. Change in sleep quality (Pittsburg Sleep Quality Index)

    Pittsburg Sleep Quality Index

    Measured: From basal, until week 96 , in each visit

  24. Change in anxiety and depression (HAD) quality of life (HIV Symptom Index questionnaire / Symptom Distress Module (HIV-SI/SDM

    Anxiety and depression (HAD) questionnaire

    Measured: From basal, until week 96 , in each visit

  25. Change in quality of life (HIV Symptom Index questionnaire / Symptom Distress Module (HIV-SI/SDM)

    Quality of life (HIV-SI/SDM) questionnaire

    Measured: From basal, until week 96 , in each visit

  26. Incidence and severity of adverse events (clinical and laboratory)

    Measured: From basal, until week 96 , in each visit

  27. Incidence of adverse events leading to treatment discontinuation.

    Measured: From basal, until week 96 , in each visit

  28. Incidence of genotypic resistance mutations in participants with virological failure

    Measured: Week 48 and week 96

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 May 2021
  2. Study start14 Jul 2021
  3. Primary completion20 Feb 2024
  4. Study completion13 Mar 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
554 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04884139
Sponsor's protocol ID
GESIDA11720
Acronym
PASO-DOBLE
Status last verified
Jul 2025
First submitted
5 May 2021
Last updated
18 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 40489982

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Dolutegravir/Lamivudine as a single pill and Bictegravir/Emtricitabine/Tenofovir alfenamide as a single pill. in people with HIV-1-infection, run by Fundacion SEIMC-GESIDA at 33 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients with plasma HIV-1 RNA ≥50 copies/mL (time frame: Week 48). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04884139, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2025.

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