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Phase I, Open Label Dose Escalation Study to Evaluate Safety of iHIVARNA-01 in Chronically HIV-infected Patients

NCT02413645 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2025-08-22

Study results available
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Summary

The main purpose of the study is to evaluate the safety and to establish the recommended dose of iHIVARNA-01 as a new therapeutic vaccine against HIV

Conditions

  • HIV-infection

Interventions

BIOLOGICAL

TriMix_100

100 μg of TriMix in

BIOLOGICAL

TriMix_300

300 μg of TriMix in

BIOLOGICAL

600μg mRNA (300 μg HIV mRNA+300 μg TriMix mRNA)

600 μg of mRNA (300 μg TriMix + 300 μg HIVACAT)

BIOLOGICAL

900μg mRNA (600 μg HIV mRNA+300 μg TriMix mRNA)

900 μg of mRNA (300 μg TriMix + 600 μg HIVACAT)

BIOLOGICAL

1200μg mRNA (900 μg HIV mRNA+300 μg TriMix mRNA)

1200 μg of mRNA (300 μg TriMix + 900 μg HIVACAT)

Sponsors & Collaborators

  • Judit Pich Martínez

    lead OTHER

Principal Investigators

  • Felipe García · Hospital Clinic of Barcelona

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2016-06-30
Completion
2016-10-31

Countries

  • Spain

Study Locations

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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 NCT02413645 on ClinicalTrials.gov