MedTrace Logo

Vedolizumab Treatment in HIV-Infected Subjects Without Previous Antiretroviral Therapy

NCT03577782 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2018-07-05

No results posted yet for this study

Summary

HIV cannot be eliminated and remains in the body despite the treatment that is used for HIV-infection called antiretroviral treatment (ART). Individuals undergoing ART interruption rapidly experience virus rebound in the blood. The current alternative therapeutic strategies to antiretroviral treatment have the aim to achieve the elimination of the virus in blood in the absence of ART. New drugs associated to ART that allow the elimination of the virus in the blood after ART withdrawn are needed. In monkeys infected with SIV, the analog of HIV, the virus has disappeared from the blood after administration of a compound and cessation of ART. There is an equivalent compound in humans called Vedolizumab. The aim of the present study is to research if Vedolizumab combined with ART, in subjects without previous ART, is able to eliminate the virus from the blood after ART is not taken.

Conditions

  • HIV Infections

Interventions

BIOLOGICAL

Entyvio (Vedolizumab)

1. Antiretroviral treatment consisting in Dolutegravir (Tivicay) (50mg) + Tenofovir alafenamide (TAF) (25mg) / Emtricitabina (FTC) (200mg) (Descovy), once daily during 24 weeks. 2. Entyvio (Vedolizumab) (300mg), 7 intravenous infusions at week 0 (baseline) (concomitant with ART onset), 4, 8, 12, 16, 20 and 24. At week 24 ART and Vedolizumab administration will be interrupted. ART will be resumed if CD4+ T-cell levels drop below 350 CD4+/μL and/or viral load increase above 10e5 HIV-RNA copies/mL (two consecutive measurements). Patients will be followed up until week 48.

Sponsors & Collaborators

  • Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

    collaborator OTHER

  • Hospitales Universitarios Virgen del Rocío

    lead OTHER

Principal Investigators

  • Ezequiel Ruiz-Mateos, PhD · Virgen del Rocio University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-30
Primary Completion
2020-05-31
Completion
2020-05-31

Countries

  • Spain

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03577782 on ClinicalTrials.gov