Safety and effi cacy of the HIV-1 attachment inhibitor prodrug BMS-663068 in treatment-experienced individuals: 24 week results of AI438011, a phase 2b, randomised controlled trial

The Lancet HIV

Volumn 2, Issue 10, 2015, Pages e427-e437

  Lalezari, Jacob P ^a   Latiff, Gulam H ^b   Brinson, Cynthia ^c   Echevarría, Juan ^d   Treviño Pérez, Sandra ^e   Bogner, Johannes R ^f   Thompson, Melanie ^g   Fourie, Jan ^h   Pena, Otto A Sussmann ⁱ   Urbina, Fernando C Mendo ^j   Martins, Marcelo ^k   Diaconescu, Iulian G ^l   Stock, David A ^m   Joshi, Samit R ^m   Hanna, George J ^m   Lataillade, Max ^m   Altclas, Javier D ^h   Amaya Tapia, Gerardo ^h   Andrade Villanueva, Jaime F ^h   Arama, Victoria ^h   Arango Duque, AIvaro ^h   Arasteh, Keikawus ^h   Arribas, Jose ^h   Bardinas Rodriguez, Rogelio ^h   Benites Villafane, Carlos M ^h   Bogner, Johannes ^h   Cahn, Pedro E ^h   Casapia Morales, Wilfredo M ^h   Cassetti, Lidia I ^h   Clotet, Bonaventura ^h   DeJesus, Edwin ^h   Echevarria, Juan I ^h   Elion, Richard ^h   Ernst, Jerome ^h   Feinberg, Judith ^h   Galindez, Jorge ^h   Gatell, M ^h   Granados Reyes, Enrique R ^h   Hassler, Shawn ^h   Hicks, Charles ^h   Johnson, David ^h   Kaplan, Richard ^h   Lalezari, Jacob ^h   Lama Valdivia, Javier R ^h   Rodriguez, Alberto M La Rosa ^h   Leon, Mey ^h   Lupo, Sergio H ^h   Marquez Diaz, Francisco ^h   Martins, Marcelo D ^h   Mckellar, Mehri ^h   Mendo Urbina, Fernando C ^h   Pinedo Ramirez, Yvett ^h   Prisacariu, Liviu J ^h   Rockstroh, Juergen ^h   Rugina, Sorin ^h   Salazar Castro, Magno R ^h   Scribner, Anita R ^h   Sierra Madero, Juan G ^h   Sloan, Louis M ^h   Stoehr, Albrecht ^h   Sussmann Pena, Otto A ^h   Tebas, Pablo ^h   Trevino Perez, Sandra C ^h   Tsybakova, Olga A ^h   Voronin, Evgeny E ^h   Yakovlev, Alexey A ^h   Zakharova, Natalia G ^h   more..

^a Quest Clinical Research   (United States)

^b Maxwell Centre   (South Africa)

^c Central Texas Clinical Research   (United States)

^d HOSPITAL NACIONAL CAYETANO HEREDIA   (Peru)

^e Mexico Center for Clinical Research   (Mexico)

^f LUDWIG MAXIMILIANS UNIVERSITY   (Germany)

^g AIDS Research Consortium of Atlanta   (United States)

^h Dr J Fourie Medical Centre ^*

ⁱ Centro de Investigación Clínica ACISC Bogota   (Colombia)

^j HOSPITAL NACIONAL EDGARDO REBAGLIATI MARTINS   (Peru)

^k University of Córdoba   (Argentina)

^l UNIVERSITY OF MEDICINE AND PHARMACY OF CRAIOVA   (Romania)

^m BRISTOL MYERS SQUIBB   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ATAZANAVIR PLUS RITONAVIR; FOSTEMSAVIR; RALTEGRAVIR; TENOFOVIR DISOPROXIL; ANTI HUMAN IMMUNODEFICIENCY VIRUS AGENT; BMS-663068; ORGANOPHOSPHATE; PIPERAZINE DERIVATIVE; PRODRUG;

ADULT; ARTICLE; CLINICAL ASSESSMENT; CONTROLLED STUDY; DRUG EFFICACY; DRUG SAFETY; FEMALE; FOLLOW UP; GASTROINTESTINAL DISEASE; HEPATOBILIARY DISEASE; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS 1 INFECTION; HYPERBILIRUBINEMIA; MALE; MULTICENTER STUDY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; STATISTICAL ANALYSIS; TREATMENT OUTCOME; VIRUS LOAD; AFRICA; CLINICAL TRIAL; COMPARATIVE STUDY; DOUBLE BLIND PROCEDURE; EUROPE; HIV INFECTIONS; MIDDLE AGED; ORAL DRUG ADMINISTRATION; PHASE 2 CLINICAL TRIAL; WESTERN HEMISPHERE;

ADMINISTRATION, ORAL; ADULT; AFRICA; AMERICAS; ANTI-HIV AGENTS; DOUBLE-BLIND METHOD; EUROPE; FEMALE; HIV INFECTIONS; HUMANS; MALE; MIDDLE AGED; ORGANOPHOSPHATES; PIPERAZINES; PRODRUGS; TREATMENT OUTCOME;

EID: 84947033432     PISSN: None     EISSN: 23523018     Source Type: Journal    
DOI: 10.1016/S2352-3018(15)00177-0     Document Type: Article

References (20)

1. May MT, Gompels M, Delpech V, et al. Impact on life expectancy of HIV-1 positive individuals of CD4+ cell count and viral load response to antiretroviral therapy. AIDS 2014; 28: 1193-202.
2. Samji H, Cescon A, Hogg RS, et al. Closing the gap: increases in life expectancy among treated HIV-positive individuals in the United States and Canada. PLoS One 2013; 8: e81355.
3. Lee FJ, Amin J, Carr A. Effi cacy of initial antiretroviral therapy for HIV-1 infection in adults: a systematic review and meta-analysis of 114 studies with up to 144 weeks' follow-up. PLoS One 2014; 9: e97482.
4. Lodwick R, Costagliola D, Reiss P, et al. Triple-class virologic failure in HIV-infected patients undergoing antiretroviral therapy for up to 10 years. Arch Intern Med 2010; 170: 410-19.
5. Nakagawa F, Lodwick R, Costagliola D, et al. Calendar time trends in the incidence and prevalence of triple-class virologic failure in antiretroviral drug-experienced people with HIV in Europe. J Acquir Immune Defi c Syndr 2012; 59: 294-99.
6. Abgrall S, Ingle SM, May MT, et al. Durability of fi rst ART regimen and risk factors for modifi cation, interruption or death in HIV-positive patients starting ART in Europe and North America 2002-2009. AIDS 2013; 27: 803-13.
7. Elzi L, Marzolini C, Furrer H. Treatment modifi cation in human immunodefi ciency virus infected individuals starting combination antiretroviral therapy between 2005 and 2008. Arch Intern Med 2010; 170: 57-65.
8. Department of Health and Human Services. Panel on antiretroviral guidelines for adults and adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. 2015. http://aidsinfo.nih.gov/ContentFiles/AdultandAdolescentGL.pdf (accessed April 21, 2015).
9. European AIDS Clinical Society. European AIDS Clinical Society Guidelines Version 7.1. 2014. http://www.eacsociety.org/fi les/ guidelines_english_71_141204.pdf (accessed May 7, 2015).
10. Langley DR, Kimura SR, Sivaprakasam P, et al. Homology models of the attachment inhibitor BMS-626529 bound to gp120 suggest a unique mechanism of action. Proteins 2015; 83: 331-50.
11. Li Z, Zhou N, Sun Y, et al. Activity of the HIV-1 attachment inhibitor BMS-626529, the active component of the prodrug BMS-663068, against CD4-independent viruses and HIV-1 envelopes resistant to other entry inhibitors. Antimicrob Agents Chemother 2013; 57: 4172-80.
12. Nowicka-Sans B, Gong YF, McAuliff e B, et al. In vitro antiviral characteristics of HIV-1 attachment inhibitor BMS-626529, the active component of the prodrug BMS-663068. Antimicrob Agents Chemother 2012; 56: 3498-507.
13. Ray N, Hwang C, Healy MD, et al. Prediction of virological response and assessment of resistance emergence to the HIV-1 attachment inhibitor BMS-626529 during 8-day monotherapy with its prodrug BMS-663068. J Acquir Immune Defi c Syndr 2013; 64: 7-15.
14. Zhou N, Nowicka-Sans B, McAuliff e B, et al. Genotypic correlates of susceptibility to HIV-1 attachment inhibitor BMS-626529, the active agent of the prodrug BMS-663068. J Antimicrob Chemother 2013; 69: 573-81.
15. Brown J, Chien C, Timmins P, et al. Compartmental absorption modeling and site of absorption studies to determine feasibility of an extended-release formulation of an HIV-1 attachment inhibitor phosphate ester prodrug. J Pharm Sci 2013; 102: 1742-51.
16. Nettles R, Schurmann D, Zhu L, et al. Pharmacodynamics, safety, and pharmacokinetics of BMS-663068, an oral HIV-1 attachment inhibitor in HIV-1-infected subjects. J Infect Dis 2012; 206: 1002-11.
17. Zhou N, Ray N, Healy M, et al. Genotypic and phenotypic correlates of virologic response to the attachment inhibitor BMS-626529 in a short-term monotherapy study with its prodrug BMS-663068. [Presentation] International Workshop on HIV & Hepatitis Virus Drug Resistance; Sitges, Spain; June 5-9, 2012. https://www. informedhorizons.com/resistance2012/pdf/Presentations/Krystal. pdf (accessed April 8, 2015).
18. Fatkenheuer G, Pozniak AL, Johnson MA, et al. Effi cacy of shortterm monotherapy with maraviroc, a new CCR5 antagonist, in patients infected with HIV-1. Nat Med 2005; 11: 1170-72.
19. Ruane PJ, DeJesus E, Berger D, et al. Antiviral activity, safety, and pharmacokinetics/pharmacodynamics of tenofovir alafenamide as 10-day monotherapy in HIV-1-positive adults. J Acquir Immune Defi c Syndr 2013; 63: 449-55.
20. Bristol-Myers Squibb. Reyataz prescribing information. 2013. http:// packageinserts.bms.com/pi/pi_reyataz.pdf (accessed Oct 22, 2014).