At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 30 enrolled
Drug / intervention
ABX464 +1 moredrug
Likely dose
ABX464 50 mgfrom 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 Multi-center, Randomized, Double-blind, Placebo-controlled Phase IIa Trial to Compare the Safety of ABX464 Given at a Fixed Dose to Placebo in Fully Controlled HIV Infected Patients Treated With Boosted Protease Inhibitor Treatment (Darunavir/Ritonavir or Darunavir/Cobicistat).
In Brief
A Phase 2 clinical trial evaluating ABX464 and Placebo for HIV Infection. Completed, enrolled 30 participants across 8 sites in 3 countries.
Detailed Summary
This study is a placebo-controlled study aimed at assessing the safety of ABX464 administered at 50 mg and 150 mg o.d. versus placebo in HIV infected patients who are treated with darunavir + ritonavir (DRV/RTV) or darunavir + cobicistat (DRV/COBI).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infection
CountriesBelgium, France, Spain
Collaborators--
Timeline
Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedApr 2016
Enrollment StartMay 2016
Primary CompletionAug 2017
Study CompletionJan 2018
TodayJul 2026
First PostedApr 13, 2016
Enrollment StartMay 1, 2016
Primary CompletionAug 30, 2017
Study CompletionJan 11, 2018
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 10.2 years ago
Interventions
ABX464drug
50 mg or 150mg once daily for 28 days
Placebodrug
ABX464 matching placebo