Trial to evaluate the safety and efficacy of a research drug in combination with antiretroviral treatment to cure people infected with HIV-1 without antiretroviral treatment.

Phase II clinical trial to evaluate the safety and efficacy of Vedolizumab combined with antiretroviral treatment to achieve functional healing in people infected with HIV-1 without previous antiretroviral treatment.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-000497-30-ES

Enrollment

Registered

2018-03-14

Start date

2018-05-28

Completion date

Unknown

Last updated

2021-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adult patients infected with HIV and without previous antiretroviral treatment. MedDRA version: 20.1 Level: PT Classification code 10020161 Term: HIV infection System Organ Class: 10021881 - Infections and infestations

Interventions

Trade Name: Entyvio® Product Name: Vedolizumab Pharmaceutical Form: Concentrate and solvent for concentrate for solution for infusion INN or Proposed INN: VEDOLIZUMAB CAS Number: 943609-66-3 Other des

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Patients with HIV infection and age = 18 years and 1x104 copies RNA/ ml ) - Levels of CD4 + > 350 cells / µL. - Accept analytical interruption of the treatment. - Written informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 12 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Presence of major resistance mutations to any of the study drugs. - Active opportunistic infections. - Pregnancy. - Active co-infection with hepatitis B or C virus or latent infection with untreated TB. - Cirrhosis, portal hypertension and / or hypersplenism of any etiology. - Past or current neoplasms subsidiary to treatment with steroids, immunomodulators or chemotherapy - Laboratory abnormalities grade 3 or 4. - Concomitant use of drugs with greater pharmacological interactions with the study drugs, according to the respective technical specifications of the products. - Estimated creatinine clearance < 50ml / min. - Have received any type of vaccination (eg, hepatitis B virus, influenza ...) two weeks before the start of the study. - Cardiovascular disease (eg, angina, heart failure, recent acute coronary syndrome) - Neurological or neuropsychiatric disease whose symptoms may interfere with the assessment of safety and tolerability. - Active abuse of alcohol and / or drugs or any pattern of behavior that, in the opinion of the researcher, could interfere with adherence to study drugs

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the safety and efficacy of Vedolizumab in combination with ART to achieve remission of Plasma viral load at undetectable levels in persons infected with HIV-1 without previous antiretroviral treatment after ART. ;Secondary Objective: Thorough virological and immunological characterization in peripheral blood and in lymphoid tissue associated with intestine (GALT). ;Primary end point(s): 1. Adverse events and their degree 2. Efficacy of Vedolizumab combined with antiretroviral treatment evaluated as the reappearance or not of HIV-1 viremia, evolution of the CD4 + lymphocyte count and the need to restart ART after finishing the infusions of Vedolizumab and suspend the concomitant ART.;Timepoint(s) of evaluation of this end point: During infusions and patient follow-up.	—

Measure

Time frame

Main Objective: To evaluate the safety and efficacy of Vedolizumab in combination with ART to achieve remission of Plasma viral load at undetectable levels in persons infected with HIV-1 without previous antiretroviral treatment after ART. ;Secondary Objective: Thorough virological and immunological characterization in peripheral blood and in lymphoid tissue associated with intestine (GALT). ;Primary end point(s): 1. Adverse events and their degree 2. Efficacy of Vedolizumab combined with antiretroviral treatment evaluated as the reappearance or not of HIV-1 viremia, evolution of the CD4 + lymphocyte count and the need to restart ART after finishing the infusions of Vedolizumab and suspend the concomitant ART.;Timepoint(s) of evaluation of this end point: During infusions and patient follow-up.

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Secondary

Measure	Time frame
Secondary end point(s): - Subpopulations of T cells, dendritic cells, monocytes, NK cells and innate lymphoid cells in PBMCs and in GALT (two ileal and cecum locations). - Array of cytokines, chemokines and inflammatory markers including retinoic acid. - Integrity of the tissue by immunohistochemical and immunofluorescence techniques. - Levels of RNA-HIV-1 in blood plasma RNA and DNA of HIV-1 associated with PBMCs and GALT. - Immunoprecipitation of HIV-1 from host molecules (a4ß7, CD29, CD54, CD11a, HLA-ABC, HLA-DR, CD27, CD43, CD45, CD46 and CD102). - Detection of Vedolizumab levels. - Detection of anti-Vedolizumab antibodies.;Timepoint(s) of evaluation of this end point: Peripheral blood: At the second visit, one week before each infusion until week 24 and every 4 weeks until week 48. GALT: The second visit and between weeks 32 and 36.	—

Measure

Time frame

Secondary end point(s): - Subpopulations of T cells, dendritic cells, monocytes, NK cells and innate lymphoid cells in PBMCs and in GALT (two ileal and cecum locations). - Array of cytokines, chemokines and inflammatory markers including retinoic acid. - Integrity of the tissue by immunohistochemical and immunofluorescence techniques. - Levels of RNA-HIV-1 in blood plasma RNA and DNA of HIV-1 associated with PBMCs and GALT. - Immunoprecipitation of HIV-1 from host molecules (a4ß7, CD29, CD54, CD11a, HLA-ABC, HLA-DR, CD27, CD43, CD45, CD46 and CD102). - Detection of Vedolizumab levels. - Detection of anti-Vedolizumab antibodies.;Timepoint(s) of evaluation of this end point: Peripheral blood: At the second visit, one week before each infusion until week 24 and every 4 weeks until week 48. GALT: The second visit and between weeks 32 and 36.

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Countries

Spain

Contacts

Public ContactUICEC-HUVR

Unidad de Investigación Clínica y ensayos Clínicos del hospital Virgen del Rocío

claram.rosso.sspa@juntadeandalucia.es0034955013414

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 7, 2026