Safety, Pharmacokinetics, and Antiviral Activity of a Novel HIV Antiviral, ABX464, in Treatment-Naive HIV-Infected Subjects in a Phase 2 Randomized, Controlled Study
Identifieur interne : 000398 ( Main/Exploration ); précédent : 000397; suivant : 000399Safety, Pharmacokinetics, and Antiviral Activity of a Novel HIV Antiviral, ABX464, in Treatment-Naive HIV-Infected Subjects in a Phase 2 Randomized, Controlled Study
Auteurs : Jean-Marc Steens [France] ; Didier Scherrer [France] ; Paul Gineste [France] ; P. Noel Barrett [France] ; Supparatpino Khuanchai [Thaïlande] ; Ratanasuwan Winai [Thaïlande] ; Kiat Ruxrungtham [Thaïlande] ; Jamal Tazi [France] ; Robert Murphy [États-Unis] ; Hartmut Ehrlich [France]Source :
- Antimicrobial Agents and Chemotherapy [ 0066-4804 ] ; 2017.
Abstract
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 (
Url:
DOI: 10.1128/AAC.00545-17
PubMed: 28507108
PubMed Central: 5487684
Affiliations:
- France, Thaïlande, États-Unis
- Illinois, Languedoc-Roussillon, Occitanie (région administrative), Île-de-France
- Montpellier, Paris
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region">Île-de-France</region><settlement type="city">Paris</settlement></placeName></affiliation></author><author><name sortKey="Scherrer, Didier" sort="Scherrer, Didier" uniqKey="Scherrer D" first="Didier" last="Scherrer">Didier Scherrer</name><affiliation wicri:level="3"><nlm:aff id="aff1">Abivax, Paris, France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Abivax, Paris</wicri:regionArea><placeName><region type="region">Île-de-France</region><region type="old region">Île-de-France</region><settlement type="city">Paris</settlement></placeName></affiliation></author><author><name sortKey="Gineste, Paul" sort="Gineste, Paul" uniqKey="Gineste P" first="Paul" last="Gineste">Paul Gineste</name><affiliation wicri:level="3"><nlm:aff id="aff1">Abivax, Paris, France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Abivax, Paris</wicri:regionArea><placeName><region type="region">Île-de-France</region><region type="old region">Île-de-France</region><settlement type="city">Paris</settlement></placeName></affiliation></author><author><name sortKey="Barrett, P Noel" sort="Barrett, P Noel" uniqKey="Barrett P" first="P. Noel" last="Barrett">P. Noel Barrett</name><affiliation wicri:level="3"><nlm:aff id="aff2">Independent Consultant, c/o Abivax, Paris, France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Independent Consultant, c/o Abivax, Paris</wicri:regionArea><placeName><region type="region">Île-de-France</region><region type="old region">Île-de-France</region><settlement type="city">Paris</settlement></placeName></affiliation></author><author><name sortKey="Khuanchai, Supparatpino" sort="Khuanchai, Supparatpino" uniqKey="Khuanchai S" first="Supparatpino" last="Khuanchai">Supparatpino Khuanchai</name><affiliation wicri:level="1"><nlm:aff id="aff3">Department of Medicine, Chiang Mai University, Chiang Mai, Thailand</nlm:aff><country xml:lang="fr">Thaïlande</country><wicri:regionArea>Department of Medicine, Chiang Mai University, Chiang Mai</wicri:regionArea><wicri:noRegion>Chiang Mai</wicri:noRegion></affiliation></author><author><name sortKey="Winai, Ratanasuwan" sort="Winai, Ratanasuwan" uniqKey="Winai R" first="Ratanasuwan" last="Winai">Ratanasuwan Winai</name><affiliation wicri:level="1"><nlm:aff id="aff4">Department of Preventive and Social Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand</nlm:aff><country xml:lang="fr">Thaïlande</country><wicri:regionArea>Department of Preventive and Social Medicine, Siriraj Hospital, Mahidol University, Bangkok</wicri:regionArea><wicri:noRegion>Bangkok</wicri:noRegion></affiliation></author><author><name sortKey="Ruxrungtham, Kiat" sort="Ruxrungtham, Kiat" uniqKey="Ruxrungtham K" first="Kiat" last="Ruxrungtham">Kiat Ruxrungtham</name><affiliation wicri:level="1"><nlm:aff id="aff5">HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT), Chulalongkorn University Hospital, Bangkok, Thailand</nlm:aff><country xml:lang="fr">Thaïlande</country><wicri:regionArea>HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT), Chulalongkorn University Hospital, Bangkok</wicri:regionArea><wicri:noRegion>Bangkok</wicri:noRegion></affiliation></author><author><name sortKey="Tazi, Jamal" sort="Tazi, Jamal" uniqKey="Tazi J" first="Jamal" last="Tazi">Jamal Tazi</name><affiliation wicri:level="3"><nlm:aff id="aff6">Institut de Genetique Moleculaire, University of Montpellier, Montpellier, France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Institut de Genetique Moleculaire, University of Montpellier, Montpellier</wicri:regionArea><placeName><region type="region">Occitanie (région administrative)</region><region type="old region">Languedoc-Roussillon</region><settlement type="city">Montpellier</settlement></placeName></affiliation></author><author><name sortKey="Murphy, Robert" sort="Murphy, Robert" uniqKey="Murphy R" first="Robert" last="Murphy">Robert Murphy</name><affiliation wicri:level="2"><nlm:aff id="aff7">Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA</nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Northwestern University Feinberg School of Medicine, Chicago, Illinois</wicri:regionArea><placeName><region type="state">Illinois</region></placeName></affiliation></author><author><name sortKey="Ehrlich, Hartmut" sort="Ehrlich, Hartmut" uniqKey="Ehrlich H" first="Hartmut" last="Ehrlich">Hartmut Ehrlich</name><affiliation wicri:level="3"><nlm:aff id="aff1">Abivax, Paris, France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Abivax, Paris</wicri:regionArea><placeName><region type="region">Île-de-France</region><region type="old region">Île-de-France</region><settlement type="city">Paris</settlement></placeName></affiliation></author></analytic><series><title level="j">Antimicrobial Agents and Chemotherapy</title><idno type="ISSN">0066-4804</idno><idno type="eISSN">1098-6596</idno><imprint><date when="2017">2017</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><title>ABSTRACT</title><p>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 (<italic>n</italic> = 6), or the corresponding placebo (<italic>n</italic> = 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.)</p></div></front><back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="Nakagawa, F" uniqKey="Nakagawa F">F Nakagawa</name></author><author><name sortKey="May, M" uniqKey="May M">M May</name></author><author><name sortKey="Phillips, A" uniqKey="Phillips A">A Phillips</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Xing, S" uniqKey="Xing S">S Xing</name></author><author><name sortKey="Siliciano, Rf" uniqKey="Siliciano R">RF Siliciano</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Lee, Gq" uniqKey="Lee G">GQ Lee</name></author><author><name sortKey="Lichterfeld, M" uniqKey="Lichterfeld M">M Lichterfeld</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Shan, L" uniqKey="Shan L">L Shan</name></author><author><name sortKey="Siliciano, Rf" uniqKey="Siliciano R">RF 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Swanstrom</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Archin, Nm" uniqKey="Archin N">NM Archin</name></author><author><name sortKey="Sung, Jm" uniqKey="Sung J">JM Sung</name></author><author><name sortKey="Garrido, C" uniqKey="Garrido C">C Garrido</name></author><author><name sortKey="Soriano Sarabia, N" uniqKey="Soriano Sarabia N">N Soriano-Sarabia</name></author><author><name sortKey="Margolis, Dm" uniqKey="Margolis D">DM Margolis</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Chun, Tw" uniqKey="Chun T">TW Chun</name></author><author><name sortKey="Moir, S" uniqKey="Moir S">S Moir</name></author><author><name sortKey="Fauci, As" uniqKey="Fauci A">AS Fauci</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Cihlar, T" uniqKey="Cihlar T">T Cihlar</name></author><author><name sortKey="Fordyce, M" uniqKey="Fordyce M">M Fordyce</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Khoury, G" uniqKey="Khoury G">G Khoury</name></author><author><name sortKey="Ewart, G" uniqKey="Ewart G">G Ewart</name></author><author><name sortKey="Luscombe, C" uniqKey="Luscombe C">C Luscombe</name></author><author><name sortKey="Miller, M" uniqKey="Miller M">M Miller</name></author><author><name sortKey="Wilkinson, J" uniqKey="Wilkinson J">J Wilkinson</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Wilkinson, J" uniqKey="Wilkinson J">J Wilkinson</name></author><author><name sortKey="Ewart, G" uniqKey="Ewart G">G Ewart</name></author><author><name sortKey="Luscombe, C" uniqKey="Luscombe C">C Luscombe</name></author><author><name sortKey="Mcbride, K" uniqKey="Mcbride K">K McBride</name></author><author><name sortKey="Ratanasuwan, W" uniqKey="Ratanasuwan W">W Ratanasuwan</name></author><author><name sortKey="Miller, M" uniqKey="Miller M">M Miller</name></author><author><name sortKey="Murphy, Rl" uniqKey="Murphy R">RL Murphy</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Chebli, K" uniqKey="Chebli K">K Chebli</name></author><author><name sortKey="Papon, L" uniqKey="Papon L">L Papon</name></author><author><name sortKey="Paul, C" uniqKey="Paul C">C Paul</name></author><author><name sortKey="Garcel, A" uniqKey="Garcel A">A Garcel</name></author><author><name sortKey="Campos, N" uniqKey="Campos N">N Campos</name></author><author><name sortKey="Scherrer, D" uniqKey="Scherrer D">D Scherrer</name></author><author><name sortKey="Ehrlich, H" uniqKey="Ehrlich H">H Ehrlich</name></author><author><name sortKey="Hahne, M" uniqKey="Hahne M">M Hahne</name></author><author><name sortKey="Tazi, J" uniqKey="Tazi J">J Tazi</name></author></analytic></biblStruct></listBibl></div1></back></TEI><affiliations><list><country><li>France</li><li>Thaïlande</li><li>États-Unis</li></country><region><li>Illinois</li><li>Languedoc-Roussillon</li><li>Occitanie (région administrative)</li><li>Île-de-France</li></region><settlement><li>Montpellier</li><li>Paris</li></settlement></list><tree><country name="France"><region name="Île-de-France"><name sortKey="Steens, Jean Marc" sort="Steens, Jean Marc" uniqKey="Steens J" first="Jean-Marc" last="Steens">Jean-Marc Steens</name></region><name sortKey="Barrett, P Noel" sort="Barrett, P Noel" uniqKey="Barrett P" first="P. Noel" last="Barrett">P. Noel Barrett</name><name sortKey="Ehrlich, Hartmut" sort="Ehrlich, Hartmut" uniqKey="Ehrlich H" first="Hartmut" last="Ehrlich">Hartmut Ehrlich</name><name sortKey="Gineste, Paul" sort="Gineste, Paul" uniqKey="Gineste P" first="Paul" last="Gineste">Paul Gineste</name><name sortKey="Scherrer, Didier" sort="Scherrer, Didier" uniqKey="Scherrer D" first="Didier" last="Scherrer">Didier Scherrer</name><name sortKey="Tazi, Jamal" sort="Tazi, Jamal" uniqKey="Tazi J" first="Jamal" last="Tazi">Jamal Tazi</name></country><country name="Thaïlande"><noRegion><name sortKey="Khuanchai, Supparatpino" sort="Khuanchai, Supparatpino" uniqKey="Khuanchai S" first="Supparatpino" last="Khuanchai">Supparatpino Khuanchai</name></noRegion><name sortKey="Ruxrungtham, Kiat" sort="Ruxrungtham, Kiat" uniqKey="Ruxrungtham K" first="Kiat" last="Ruxrungtham">Kiat Ruxrungtham</name><name sortKey="Winai, Ratanasuwan" sort="Winai, Ratanasuwan" uniqKey="Winai R" first="Ratanasuwan" last="Winai">Ratanasuwan Winai</name></country><country name="États-Unis"><region name="Illinois"><name sortKey="Murphy, Robert" sort="Murphy, Robert" uniqKey="Murphy R" first="Robert" last="Murphy">Robert Murphy</name></region></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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