At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 21 enrolled
Drug / intervention
TriMix_100 +4 morebiological
Likely dose
600μg mRNA (300 μg HIV mRNA+300 μg TriMix mRNA)from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase I, Open Label Dose Escalation Study to Evaluate Safety of iHIVARNA-01 in Chronically HIV-infected Patients Under Stable Combined Antiretroviral Therapy
In Brief
A Phase 1 clinical trial evaluating TriMix_100, TriMix_300, and 3 other interventions for HIV-infection. Completed, enrolled 21 participants across 1 site.
Detailed 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
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV-infection
CountriesSpain
Collaborators--
Timeline
Phase 1CompletedFinished
201520162017201820192020202120222023202420252026
First PostedApr 2015
Enrollment StartJun 2015
Primary CompletionJun 2016
Study CompletionOct 2016
TodayJul 2026
First PostedApr 10, 2015
Enrollment StartJun 1, 2015
Primary CompletionJun 1, 2016
Study CompletionOct 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 11.2 years ago
Interventions
TriMix_100biological
100 μg of TriMix in
TriMix_300biological
300 μg of TriMix in
600μg mRNA (300 μg HIV mRNA+300 μg TriMix mRNA)biological
600 μg of mRNA (300 μg TriMix + 300 μg HIVACAT)
900μg mRNA (600 μg HIV mRNA+300 μg TriMix mRNA)biological
900 μg of mRNA (300 μg TriMix + 600 μg HIVACAT)
1200μg mRNA (900 μg HIV mRNA+300 μg TriMix mRNA)biological
1200 μg of mRNA (300 μg TriMix + 900 μg HIVACAT)