PMID- 28507108
OWN - NLM
STAT- MEDLINE
DCOM- 20180403
LR  - 20220331
IS  - 1098-6596 (Electronic)
IS  - 0066-4804 (Print)
IS  - 0066-4804 (Linking)
VI  - 61
IP  - 7
DP  - 2017 Jul
TI  - Safety, Pharmacokinetics, and Antiviral Activity of a Novel HIV Antiviral, 
      ABX464, in Treatment-Naive HIV-Infected Subjects in a Phase 2 Randomized, 
      Controlled Study.
LID - 10.1128/AAC.00545-17 [doi]
LID - e00545-17
AB  - We investigated the safety and antiviral effects of an anti-HIV compound (ABX464) 
      with a unique mechanism of viral replication inhibition. This was a randomized, 
      double-blind, placebo-controlled, dose-ranging study in treatment-naive 
      HIV-infected patients. Participants were assigned to eight groups; each group 
      included eight subjects receiving either the study compound, ABX464 (n = 6), or 
      the corresponding placebo (n = 2), according to a randomization code. The first 
      dose administered was 25 mg, given once or 3 times a day over a 2- to 3-week 
      period. Ascending doses of up to 150 mg were delivered after review of the safety 
      data. The primary objective of the study was to assess the safety and 
      tolerability of ABX464 after repeated oral administrations in subjects infected 
      by HIV. Sixty-six subjects were enrolled and were randomized. Sixty-three 
      subjects completed the study according to the study protocol. Twenty-one adverse 
      events (AEs) were reported by 7 subjects out of 16 (44%) who received placebo, 
      and 158 AEs were reported by 39 subjects out of 50 (78%) who received the study 
      drug. In the ABX464 treatment group, all of these adverse events were mild to 
      moderate. No subjects discontinued treatment due to drug-related AEs. 
      Administration of ABX464 at up to 150 mg once a day was safe and well tolerated 
      in HIV-infected subjects. An efficacy signal with respect to a reduction of the 
      viral load by ABX464 was detected, mainly in subjects treated at the highest 
      dose. Further studies will be required to demonstrate antiviral effects in 
      HIV-infected subjects in combination with other antiretroviral therapies. (This 
      study is registered on the ClinicalTrials.gov website under registration no. 
      NCT02452242.).
CI  - Copyright (c) 2017 Steens et al.
FAU - Steens, Jean-Marc
AU  - Steens JM
AD  - Abivax, Paris, France.
FAU - Scherrer, Didier
AU  - Scherrer D
AD  - Abivax, Paris, France.
FAU - Gineste, Paul
AU  - Gineste P
AD  - Abivax, Paris, France Paul.Gineste@abivax.com.
FAU - Barrett, P Noel
AU  - Barrett PN
AD  - Independent Consultant, c/o Abivax, Paris, France.
FAU - Khuanchai, Supparatpino
AU  - Khuanchai S
AD  - Department of Medicine, Chiang Mai University, Chiang Mai, Thailand.
FAU - Winai, Ratanasuwan
AU  - Winai R
AD  - Department of Preventive and Social Medicine, Siriraj Hospital, Mahidol 
      University, Bangkok, Thailand.
FAU - Ruxrungtham, Kiat
AU  - Ruxrungtham K
AD  - HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT), 
      Chulalongkorn University Hospital, Bangkok, Thailand.
FAU - Tazi, Jamal
AU  - Tazi J
AD  - Institut de Genetique Moleculaire, University of Montpellier, Montpellier, 
      France.
FAU - Murphy, Robert
AU  - Murphy R
AD  - Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.
FAU - Ehrlich, Hartmut
AU  - Ehrlich H
AD  - Abivax, Paris, France.
LA  - eng
SI  - ClinicalTrials.gov/NCT02452242
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20170627
PL  - United States
TA  - Antimicrob Agents Chemother
JT  - Antimicrobial agents and chemotherapy
JID - 0315061
RN  - 0 (ABX464)
RN  - 0 (Anti-HIV Agents)
RN  - 0 (Quinolines)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Anti-HIV Agents/adverse effects/pharmacokinetics/*therapeutic use
MH  - Double-Blind Method
MH  - Female
MH  - HIV Infections/drug therapy
MH  - HIV-1/*drug effects/*pathogenicity
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Quinolines/adverse effects/pharmacokinetics/*therapeutic use
MH  - Treatment Outcome
MH  - Viral Load/drug effects
MH  - Virus Replication/drug effects
MH  - Young Adult
PMC - PMC5487684
OTO - NOTNLM
OT  - ABX464
OT  - human immunodeficiency virus
EDAT- 2017/05/17 06:00
MHDA- 2018/04/04 06:00
PMCR- 2017/06/27
CRDT- 2017/05/17 06:00
PHST- 2017/03/14 00:00 [received]
PHST- 2017/05/04 00:00 [accepted]
PHST- 2017/05/17 06:00 [pubmed]
PHST- 2018/04/04 06:00 [medline]
PHST- 2017/05/17 06:00 [entrez]
PHST- 2017/06/27 00:00 [pmc-release]
AID - AAC.00545-17 [pii]
AID - 00545-17 [pii]
AID - 10.1128/AAC.00545-17 [doi]
PST - epublish
SO  - Antimicrob Agents Chemother. 2017 Jun 27;61(7):e00545-17. doi: 
      10.1128/AAC.00545-17. Print 2017 Jul.