CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 36 enrolled
Drug / intervention
ABX464 150mg +2 moredrug
Likely dose
ABX464 150mgfrom 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.

Search/NCT02990325
NCT02990325Phase 2Completed
CompareCT.gov

An Open-Label Study of the Safety, Pharmacokinetics, and Pharmacodynamics of ABX464 in HIV-1 Seronegative and Seropositive Adults

Abivax S.A.·interventional·Posted Dec 13, 2016·Updated Mar 31, 2023

In Brief

A Phase 2 clinical trial evaluating ABX464 150mg and ABX464 50mg for HIV Infections and Health Volunteers. Completed, enrolled 36 participants across 1 site.

Detailed Summary

The purpose of the ABX464-005 study is to characterize the systemic and mucosal immunological sequelae associated with exposure to ABX464 and to explore selected immunological endpoints, compartmental pharmacokinetics, and pharmacodynamics.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections, Health Volunteers
CountriesSpain
Collaborators--

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedDec 13, 2016
Enrollment StartMar 27, 2017
Primary CompletionDec 27, 2018
Study CompletionOct 21, 2019
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 9.6 years ago

Interventions

ABX464 150mgdrug

ABX464 given orally at 150 mg per day from Day 0 to Day 28 (Cohort 1/ HIV infected subjects)

ABX464 50mgdrug

ABX464 given orally at 50 mg per day from Day 0 to Day 28 (Cohort 2 / non HIV infected subjects)

ABX464 50mgdrug

ABX464 given orally at 50 mg per day from Day 0 to Day 84 (Cohort 3 / HIV infected subjects)