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OpenTrials
Completed

NCT Number: NCT04884139

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

H. Marina Baixa, Villajoyosa, Alicante, Spain

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Dolutegravir/Lamivudine as a single pill

Drug
  • 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.

Primary outcomes

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

    Time frame: Week 48

Secondary outcomes

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

    Time frame: week 96

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

    Time frame: Week 48 and week 96

  3. Absolute weight

    Time frame: Basal, week 48 y week 96

  4. BMI change

    Time frame: Basal, week 48 y week 96

  5. Proportion of patients with weight change >5%

    Time frame: Basal, week 48 y week 96

  6. Absolute values in CD4+ cells count

    Time frame: Basal, week 48 y week 96

  7. Changes in CD4+ cells count

    Time frame: Basal, week 48 y week 96

  8. Absolute values CD4:CD8 ratio

    Time frame: Basal, week 48 y week 96

  9. Changes CD4:CD8 ratio

    Time frame: Basal, week 48 y week 96

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

    Time frame: Basal, week 48 y week 96

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

    Time frame: Basal, week 48 y week 96

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

    Time frame: Basal, week 48 y week 96

  13. Change trabecular bone score (TBS) by DXA

    Time frame: Basal, week 48 y week 96

  14. Change in subcutaneous and visceral fat (CT)

    Time frame: Basal, week 48 y week 96

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

    Time frame: Basal, week 48 y week 96

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

    Time frame: Basal, week 48 y week 96

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

    Time frame: Basal, week 48 y week 96

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

    Time frame: Basal, week 48 y week 96

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

    Time frame: Basal, week 48 y week 96

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

    Time frame: Basal, week 48 y week 96

  21. Changes in urinary protein/creatinine

    Time frame: Basal, week 48 y week 96

  22. Change in blood pressure

    Time frame: Basal, week 48 y week 96

    Systolic and Diastolic Blood Pressure

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

    Time frame: From basal, until week 96 , in each visit

    Pittsburg Sleep Quality Index

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

    Time frame: From basal, until week 96 , in each visit

    Anxiety and depression (HAD) questionnaire

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

    Time frame: From basal, until week 96 , in each visit

    Quality of life (HIV-SI/SDM) questionnaire

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

    Time frame: From basal, until week 96 , in each visit

  27. Incidence of adverse events leading to treatment discontinuation.

    Time frame: From basal, until week 96 , in each visit

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

    Time frame: Week 48 and week 96

Sponsors and collaborators

Lead sponsor

Fundacion SEIMC-GESIDA

Other

Collaborators

  • ViiV Healthcare

Registry information

Official study title

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

Acronym: PASO-DOBLE

Important dates

Study start
2021
Primary completion
2024
Study completion
2025
First posted
May 12, 2021
Registry last updated
Jul 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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