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Official Title Randomized, Open Label, Multiple-Dose Study to Evaluate the Pharmacodynamics, Safety and Pharmacokinetics of Fostemsavir (BMS-663068) in HIV-1 Infected Subjects
Phase Phase IIA
ClinicalTrials.gov NCT01009814
Treatments
Fostemsavir
Fostemsavir
Tradename:RukobiaOther Names:FTRClass:Entry InhibitorsCategories PharmacologyTreatment-NaiveTreatment-ExperiencedGeneral PharmacologyResistance/Virological Failure
Funding
IndustryBristol-Myers Squibb
References
- Nettles RE, Schürmann 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.
- 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 Defic Syndr. 2013;64:7-15.
- Zhou N, Nowicka-Sans B, McAuliffe 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. 2014;69:573-81.
Official Title A Phase IIb Randomized, Controlled, Partially-Blinded Trial to Investigate Safety, Efficacy and Dose-Response of Fostemsavir (BMS-663068) in Treatment-experienced HIV-1 Subjects, Followed by an Open-Label Period on the Recommended Dose
Phase Phase IIB
ClinicalTrials.gov NCT01384734
Treatments
Fostemsavir
Fostemsavir
Tradename:RukobiaOther Names:FTRClass:Entry InhibitorsCategories Resistance/Virological FailureTreatment-ExperiencedPharmacologyAdverse Effects
Funding
IndustryBristol-Myers Squibb
References
- Brinson C, Lalezari J, Gulam LH, et al. HIV-1 attachment inhibitor prodrug BMS-663068 in antiretroviral-experienced subjects: week 24 sub-group analysis. J Int AIDS Soc. 2014;17:19529.
- Lalezari J, Latiff GH, Brinson C, et al. Safety profile of HIV-1 attachment inhibitor prodrug BMS-663068 in antiretroviral-experienced subjects: week 24 analysis. J Int AIDS Soc. 2014;17:19530.
- Lalezari JP, Latiff GH, Brinson C, et al. Safety and efficacy of the HIV-1 attachment inhibitor prodrug BMS-663068 in treatment-experienced individuals: 24 week results of AI438011, a phase 2b, randomised controlled trial. Lancet HIV. 2015;2:e427-37.
- Thompson M, Lalezari JP, Kaplan R, et al. Safety and efficacy of the HIV-1 attachment inhibitor prodrug fostemsavir in antiretroviral-experienced subjects: week 48 analysis of AI438011, a Phase IIb, randomized controlled trial. Antivir Ther. 2017;22:215-223.
Official Title A Multi-arm Phase 3 Randomized Placebo Controlled Double Blind Clinical Trial to Investigate the Efficacy and Safety of Fostemsavir (BMS-663068) in Heavily Treatment Experienced Subjects Infected With Multi-drug Resistant HIV-1
Purpose / DescriptionPhase III
Phase Phase III
ClinicalTrials.gov NCT02362503
Treatments
Fostemsavir
Fostemsavir
Tradename:RukobiaOther Names:FTRClass:Entry InhibitorsCategories Resistance/Virological FailureTreatment-Experienced
Funding
IndustryBristol-Myers Squibb
References
- Kozal M, Aberg J, Pialoux G, et al. Fostemsavir in Adults with Multidrug-Resistant HIV-1 Infection. N Engl J Med. 2020;382:1232-43.