NCT02452242

Safety, PK and PD Study of ABX464 in Untreated HIV Patients

A Phase 2, Dose Escalation, Schedule Comparison Study to Evaluate the Safety, Pharmacokinetics, and Viral Kinetics of ABX464 in Untreated Patients With HIV Infection in Mauritius

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Abivax S.A. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

ABX464 is a first in class that showed efficacy as an anti-HIV therapy. The present study is intended to assess the safety, the tolerability, and pharmacokinetic parameters and to evaluate the effect on viral load of repeated oral administrations of ABX464 in patients infected by HIV, not previously treated for their HIV. Two types of design are intended in this protocol: dosing every 3 days or dosing every day. The goal is to determine the best dosing regimen to reduce viral load and minimize adverse events.

Conditions

• Human Immunodeficiency Virus Infections

Interventions

Type	Name	Description
DRUG	ABX464	25, 50, 75, 100, 150 mg, i.e. 1, 2, 3, 4 or 6 capsules respectively, every 3 days or every day for 2 weeks
OTHER	Placebo	1, 2, 3, 4 or 6 capsules respectively, every 3 days or every day for 2 weeks

Timeline

• Start date: 2015-01-01
• Primary completion: 2015-12-01
• Completion: 2016-05-01
• First posted: 2015-05-22
• Last updated: 2016-05-30

Locations

4 sites across 2 countries: Mauritius, Thailand