NCT04076423

Brief Summary

242 patients (121 patients in each of the two treatment arms) will be included with a confirmed diagnosis of HIV-1 infection and with a stable antiretroviral treatment during more than 48 weeks with dual therapy (DTG + 3TC)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
141

participants targeted

Target at P50-P75 for phase_4 hiv-infections

Timeline
Completed

Started Oct 2019

Longer than P75 for phase_4 hiv-infections

Geographic Reach
1 country

18 active sites

Status
completed

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

August 27, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 3, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

October 10, 2019

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2023

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 16, 2024

Completed
Last Updated

October 1, 2024

Status Verified

June 1, 2024

Enrollment Period

3.7 years

First QC Date

August 27, 2019

Last Update Submit

September 30, 2024

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (1)

  • sCD14

    Changes in sCD14 concentration

    Screening, basal, week 23, week 24, week 47, week 48, week 95 y week 96

Secondary Outcomes (9)

  • Changes in PCR-us

    Screening, basal, week 23, week 24, week 47, week 48, week 95 y week 96

  • Changes in sCD163

    Screening, basal, week 23, week 24, week 47, week 48, week 95 y week 96

  • Changes in quinurenine / tryptophan ratio

    Screening, basal, week 23, week 24, week 47, week 48, week 95 y week 96

  • Changes in Dimer D

    Screening, basal, week 23, week 24, week 47, week 48, week 95 y week 96

  • Changes in CD4/CD8 ratio

    Screening, basal, week 23, week 24, week 47, week 48, week 95 y week 96

  • +4 more secondary outcomes

Study Arms (2)

Experimental arm:

EXPERIMENTAL

they will take 1 tablet (50 mg BIC + 200 mg FTC + 25 mg TAF), orally, once a day, from the moment of randomization.

Drug: Triple therapy

Comparator arm

ACTIVE COMPARATOR

they will take 1 tablet of 50 mg of DTG orally, once a day + 1 tablet of 300 mg of 3TC orally, once a day, from the randomization moment.

Drug: Dual Therapy

Interventions

Dual TherapyDRUG

DTG + 3TC

Comparator arm
Triple therapyDRUG

BIC / FTC / TAF

Experimental arm:

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women ≥ 18 years
  • Confirmed and documented diagnosis of HIV-1 infection
  • Virological suppression of more than 48 weeks (confirmed with HIV RNA \<50 copies / ml). The determination of the CV of a routine prior analysis of ≤ 12 weeks prior to signature of consent.
  • ART in stable dual therapy (\> 48 weeks) with DTG + 3TC
  • Signed informed consent
  • Negative pregnancy test in urine or blood

You may not qualify if:

  • Inability to obtain written informed consent to participate in the study
  • Pregnant or breastfeeding women or those who intend to become pregnant during the study period and do not undertake to use proven contraceptive methods.
  • Any suspicion or confirmation of resistance to TAF, 3TC, FTC, DTG or BIC. In case of have a study of baseline resistance mutations prior to the start of ART has to rule out resistance to investigational drugs.
  • Patients with hypersensitivity to any excipient used with TAF, FTC, DTG or BIC
  • Any chronic autoimmune or inflammatory disease
  • Use of immunomodulatory or immunosuppressive agents, including steroids Chronic treatment with aspirin, statins and other anti-inflammatory agents
  • Any acute infection in the last 2 months
  • Estimated glomerular filtration rate (TFGe) \<30 mg / ml / m2 measured by any of the formulas available. The determination of the TFGe of a previous routine analysis of ≤ 12 weeks prior to signing the consent is allowed
  • Contraindication for the use of TAF
  • Clinical condition of the patient in rapid deterioration or the investigator considers that there is no reasonable hope that the patient will finish the study
  • Simultaneous participation in another clinical trial or research study that requires the need of treatment with other drugs outside the study or interfere with the visits of the same.
  • Any situation that, in the opinion of the investigator, may interfere with the patient's ability to meet the treatment schedule and protocol evaluations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

Hospital San Pedro

Logroño, La Rioja, 26006, Spain

Location

Hospital Universitario Príncipe de Asturias

Alcalá de Henares, Madrid, 28002, Spain

Location

Hospital Universitario Puerta de Hierro

Majadahonda, Madrid, 28222, Spain

Location

Hospital de Bellvitge

Barcelona, Spain

Location

Hospital Univ. Vall D'Hebron

Barcelona, Spain

Location

H. General Universitario Guadalajara

Guadalajara, Spain

Location

Hospital Universitario Infanta Leonor

Madrid, 28050, Spain

Location

Hospital Clínico San Carlos

Madrid, Spain

Location

Hospital Fundación Jimenez Diaz

Madrid, Spain

Location

Hospital Univ. La Paz

Madrid, Spain

Location

Hospital Univ. Ramón y Cajal

Madrid, Spain

Location

Hospital Virgen de las Nieves

Malá, Spain

Location

Hospital Virgen de la Victoria

Málaga, Spain

Location

H. General Universitario Reina Sofía

Murcia, 30003, Spain

Location

Hospital Univ. Virgen del Rocio

Seville, Spain

Location

H. Universitario y Politécnico La Fe

Valencia, 46026, Spain

Location

Hospital Univ. Clínico de Valencia

Valencia, Spain

Location

Hospital Univ. Lozano Blesa

Zaragoza, Spain

Location

Related Publications (1)

  • Saborido-Alconchel A, Serna-Gallego A, Trujillo-Rodriguez M, Munoz-Muela E, Alvarez-Rios AI, Lozano C, Llaves-Flores S, Espinosa N, Roca-Oporto C, Herrero M, Sotomayor C, Gutierrez-Valencia A, Lopez-Cortes LF. Long-term effects on immunological, inflammatory markers, and HIV-1 reservoir after switching to a two-drug versus maintaining a three-drug regimen based on integrase inhibitors. Front Immunol. 2024 Jul 11;15:1423734. doi: 10.3389/fimmu.2024.1423734. eCollection 2024.

    PMID: 39055703DERIVED

MeSH Terms

Conditions

HIV Infections

Interventions

Dual Anti-Platelet Therapy

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

Drug Therapy, CombinationDrug TherapyTherapeutics

Study Officials

  • Santiago Moreno, MD

    Hospital Univ. Ramón y Cajal

    PRINCIPAL INVESTIGATOR

  • Sergio Serrano, MD

    Hospital Univ. Ramón y Cajal

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Comparator: the patient will continue taking the dual therapy. Experimental: the patient Will beging to take triple therapy.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 27, 2019

First Posted

September 3, 2019

Study Start

October 10, 2019

Primary Completion

June 15, 2023

Study Completion

January 16, 2024

Last Updated

October 1, 2024

Record last verified: 2024-06

Locations

ES(18)