NCT02413645

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

A Phase I, Open Label Dose Escalation Study to Evaluate Safety of iHIVARNA-01 in Chronically HIV-infected Patients Under Stable Combined Antiretroviral Therapy

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Judit Pich Martínez · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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)

Timeline

• Start date: 2015-06-01
• Primary completion: 2016-06-01
• Completion: 2016-10-01
• First posted: 2015-04-10
• Last updated: 2025-08-22
• Results posted: 2025-08-22

Locations

1 site across 1 country: Spain