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Safety, Tolerability and Immunogenicity of MVA.HTI and ChAdOx1.HTI With Vesatolimod in HIV-1 Positive Patients

NCT04364035 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2023-07-27

No results posted yet for this study

Summary

AELIX-003 study aims to investigate the safety, tolerability, immunogenicity and efficacy of a regimen containing AELIX Therapeutics' HTI T-cell vaccines and Gilead´s Toll-Like Receptor 7 (TLR7) agonist vesatolimod in HIV-infected individuals on antiretroviral therapy. Study that will be conducted in 57 participants who have started antiretroviral therapy during early HIV infection, enrolled at various clinical trial sites in Spain. All participants will be on antiretroviral therapy upon starting the study, with their HIV viral loads \<50 copies/mL. Following exposure to the vaccine/vesatolimod, all participants, under careful monitoring, will temporarily stop their antiretroviral drugs to determine if the intervention is effective in keeping their HIV levels under control.

Conditions

Interventions

BIOLOGICAL

ChAdOx1.HTI

ChAdOx1.HTI at week 0 and week 12; Vaccine delivered as one 0. 5 mL IM injection

BIOLOGICAL

MVA.HTI

MVA.HTI at week 24 and week 36; Vaccine delivered as one 0. 5 mL IM injection

DRUG

GS-9620

GS-9620 at week 26,28,30,32,34,38,40,42,44 and 46 Unit-dose tablet, delivered as two 3-mg tablets

BIOLOGICAL

Placebo

Saline placebo delivered as one 0. 5 mL IM injection

DRUG

Placebo Oral Tablet

Unit-dose placebo tablet delivered as two 3-mg placebo tablets

Sponsors & Collaborators

Principal Investigators

  • Jose R Arribas Lopez, Md, PhD · Hospital Universitario La Paz

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-02-20
Primary Completion
2022-10-03
Completion
2022-12-16
FDA Drug
Yes

Countries

  • Spain

Study Locations

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Entities

Drugs
Diseases
Companies

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 NCT04364035 on ClinicalTrials.gov