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HIV InfectionPhase 4TRIDUNANCT04295460

Triple vs. Double Therapy in naïves HIV-Infected Patients

A Phase 4 study testing Randomize in people with HIV Infection, run by Hospitales Universitarios Virgen del Rocío at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The objective of this study is to clarify whether if starting antiretroviral treatment based on dual therapy (DTG + 3TC) could provide less control of residual HIV replication and, therefore, a detriment on immune activation and inflammation compared to starting with triple therapy, and could worsen the patients'… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV Infection
What is being tested?
Randomize
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteSpain
Study dates
10 Mar 2020to Mar 2023
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

  • Treatment-naïve HIV-1-infected patients ≥ 18 years of age.
  • Plasma HIV-1 RNA >5000 and <500.000 copies/ml.
  • T lymphocyte CD4+ count in peripheral blood >200/μl.
  • Patients of childbearing age should consent to use a highly effective contraceptive method from 15 days before the time of inclusion of the study until 30 days after the end of it. It is considered a highly effective method:
  • Complete abstinence from penile-vaginal intercourse from 2 weeks prior to administration of Investigational Product, throughout the study, and for at least 2 weeks after discontinuation of all study medications;
  • Any intrauterine device with published data showing that the expected failure rate is <1% per year (not all intrauterine devices meet this criterion)
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  • Male partner sterilization confirmed prior to the female subject's entry into the study, and this male is the sole partner for that subject.
  • Approved hormonal contraception.
  • Any other method with published data showing that the expected failure rate is <1% per year.
  • Signed written informed consent prior to inclusion.

Who cannot join

  • Acute HIV infection
  • T lymphocyte CD4+ count in peripheral blood ≤ 200/µl
  • Active opportunistic infection.
  • Pregnancy at inclusion or during the follow-up
  • Active hepatitis C and/or B virus co-infection.
  • ALT ≥ 5 times the ULN, or ALT ≥ 3xULN and bilirubin ≥ 1.5xULN (with >35% direct bilirubin).
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  • 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.
  • Current or past disease that requires the use subsidiary of treatment with corticosteroids, immunomodulatory agents, interferon or chemotherapeutic agents.
  • Any laboratory abnormality grade 3 or 4 according to the U.S. Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Division of AIDS (Annex 3)
  • Concomitant use of drugs with potential major interactions with the prescribed drugs according to the respective full prescribing information.
  • Estimated creatinine clearance <50ml/min.
  • History or presence of allergy to the study drugs or their components

Trial locations and contacts

1 site in 1 country.

Spain1 site, 1 recruiting

  • Hospital Universitario Virgen del Rocio

    Seville, 41013

    Luis F Lopez-Cortes, MD, PhD, 34 - 955013096, lflopez@us.es

    Luis F Lopez-Cortes, MD, PhD

    Recruiting

Other trials in Spain

About this study

Official title: Effectiveness of a Dual Therapy (Dolutegravir + Lamivudine) on Reduction of the Viral Reservoir, Immune Recovery and Immune Activation Compared With a Triple Therapy (Dolutegravir + Tenofovir Alafenamide/Emtricitabine) in Treatment-naïve HIV-Infected Patients

The objective of this study is to clarify whether if starting antiretroviral treatment based on dual therapy (DTG + 3TC) could provide less control of residual HIV replication and, therefore, a detriment on immune activation and inflammation compared to starting with triple therapy, and could worsen the patients' long-term prognosis. For this purpose, the investigator has designed a randomized clinical trial where will assess the immunological recovery (CD4+/CD8+), immune activation, proliferation, senescence and apoptosis in T lymphocytes CD4+ and CD8+ cells by flow cytometry, the immune activation of monocytes/ macrophages and plasma concentrations of various inflammatory mediators by ELISAS, and the thymic function, the cellular reservoir of HIV and the degree of HIV DNA transcription by digital dropped PCR.

Conditions
HIV Infection
Being tested
Randomize
Medical subject headings
HIV Infections

What participants receive

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

  • RandomizeDrug

    Also called Triple therapy

    Randomize to naive-treatment HIV-infected patients to receive dual o triple therapy as initial antiretroviral treatment

Study groups in NCT04295460
Study groupRoleWhat they receive
Dual TherapyExperimentalDolutegravir plus lamivudine
Receives: Drug: Randomize
Triple TherapyActive comparatorDolutegravir plus TAF/FTC
Receives: Drug: Randomize

What is being measured

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

  1. proviral HIV-DNA

    Mean changes in proviral HIV-DNA in PBMCs after 48 and 96 weeks of treatment

    Measured: 48 and 96 weeks

Secondary outcomes (6)

  1. Immune Recovery

    Mean changes immune recovery assessed by CD4+/CD8+ T cell ratio.

    Measured: 48 and 96 weeks

  2. Immune Activation

    Mean changes immune activation assessed by the expression of HLA-DR and CD38 in both of CD4+ and CD8+ T cells.

    Measured: 48 and 96 weeks

  3. Monocytes Activation

    Mean changes monocytes activation (plasma sCD14 and sCD163).

    Measured: 48 and 96 weeks

  4. Immunosenescense

    Mean changes expression of markers for recent thymic emigrants (CD31), proliferation (Ki67), dysfunction (PD-1), senescence (CD57), and apoptosis (annexin A) in both CD4+ and CD8+ T cells.

    Measured: 48 and 96 weeks

  5. Inflammation

    Mean changes concentration of pro-inflammatory soluble mediator in plasma: TNF-α, IL-1β, IL-6, IP-10, IFN- γ, MIP-1α, MIP-1β, hsPCR y D-dímers.

    Measured: 48 and 96 weeks

  6. Viral Reservoir

    Mean changes viral reservoir size, evaluated by proviral HIV-DNA and HIV-RNA in peripheral blood mononuclear cells (PBMC) and CD4+ T cells isolate.

    Measured: 48 and 96 weeks

Timeline

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

  1. First posted4 Mar 2020
  2. Study start10 Mar 2020
  3. Primary completionJan 2022 (estimated)
  4. Study completionMar 2023 (estimated)

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
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04295460
Sponsor's protocol ID
FIS-TAR-01-2019
Acronym
TRIDUNA
Status last verified
Aug 2020
First submitted
2 Mar 2020
Last updated
18 Aug 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Saborido-Alconchel A, Serna-Gallego A, Lopez-Cortes LE, Trujillo-Rodriguez M, Praena-Fernandez JM, Dominguez-Macias M, Lozano C, Munoz-Muela E, Espinosa N, Roca-Oporto C, Sotomayor C, Herrero M, Gutierrez-Valencia A, Lopez-Cortes LF. Decay kinetics of HIV-1-RNA in seminal plasma with dolutegravir/lamivudine versus dolutegravir plus emtricitabine/tenofovir alafenamide in treatment-naive people living with HIV. J Antimicrob Chemother. 2023 Sep 5;78(9):2354-2360. doi: 10.1093/jac/dkad245.

    PubMed 37545387

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Randomize in people with HIV Infection, run by Hospitales Universitarios Virgen del Rocío at 1 site 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 10 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 18 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Results are not available in the source record.

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

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

proviral HIV-DNA (time frame: 48 and 96 weeks). 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 NCT04295460, 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 Aug 2020.

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