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Common TitleAI438-011
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 Rukobia

Fostemsavir

Tradename:RukobiaOther Names:FTRClass:Entry Inhibitors
Categories 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.
    [PubMed Abstract]
  • 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.
    [PubMed Abstract]
  • 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.
    [PubMed Abstract]
  • 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.
    [PubMed Abstract]

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