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Common TitleTORO-2
Official Title A Phase III Open-Label, Randomized, Active-Controlled Study Assessing the Efficacy and Safety of T-20 (HIV-1 Fusion Inhibitor) in Combination With an Optimized Background Regimen, Versus Optimized Background Regimen Alone, in Patients With Prior Experience and/or Prior Documented Resistance to Each of the Three Classes of Approved Antiretrovirals (Nucleoside Reverse Transcriptase, Non-Nucleoside Reverse Transcriptase and Protease Inhibitors)
Phase Phase III
ClinicalTrials.gov NCT00021554
Treatments
Enfuvirtide
Enfuvirtide Fuzeon

Enfuvirtide

Tradename:FuzeonOther Names:T-20Class:Entry Inhibitors
Categories Resistance/Virological FailureTreatment-ExperiencedPharmacologyAdverse Effects
Funding
IndustryHoffmann-La Roche
References
  • Cohen CJ, Clumeck N, Molina JM, et al. Health-related quality of life with enfuvirtide (ENF; T-20) in combination with an optimized background regimen. J Acquir Immune Defic Syndr. 2004;37:1140-6.
    [PubMed Abstract]
  • Cooper DA, Cordery DV, Reiss P, et al. The effects of enfuvirtide therapy on body composition and metabolic parameters over 48 weeks in the TORO body imaging substudy. HIV Med. 2011;12:31-9.
    [PubMed Abstract]
  • Lazzarin A, Clotet B, Cooper D, et al. Efficacy of enfuvirtide in patients infected with drug-resistant HIV-1 in Europe and Australia. N Engl J Med. 2003;348:2186-95.
    [PubMed Abstract]
  • Melby T, Sista P, DeMasi R, et al. Characterization of envelope glycoprotein gp41 genotype and phenotypic susceptibility to enfuvirtide at baseline and on treatment in the phase III clinical trials TORO-1 and TORO-2. AIDS Res Hum Retroviruses. 2006;22:375-85.
    [PubMed Abstract]
  • Melby TE, Despirito M, Demasi RA, et al. Association between specific enfuvirtide resistance mutations and CD4 cell response during enfuvirtide-based therapy. AIDS. 2007;21:2537-9.
    [PubMed Abstract]
  • Nelson M, Arastéh K, Clotet B, et al. Durable efficacy of enfuvirtide over 48 weeks in heavily treatment-experienced HIV-1-infected patients in the T-20 versus optimized background regimen only 1 and 2 clinical trials. J Acquir Immune Defic Syndr. 2005;40:404-12.
    [PubMed Abstract]
  • Raffi F, Katlama C, Saag M, et al. Week-12 response to therapy as a predictor of week 24, 48, and 96 outcome in patients receiving the HIV fusion inhibitor enfuvirtide in the T-20 versus Optimized Regimen Only (TORO) trials. Clin Infect Dis. 2006;42:870-7.
    [PubMed Abstract]
  • Reynes J, Arastéh K, Clotet B, et al. TORO: ninety-six-week virologic and immunologic response and safety evaluation of enfuvirtide with an optimized background of antiretrovirals. AIDS Patient Care STDS. 2007;21:533-43.
    [PubMed Abstract]
  • Rockstroh J, Dejesus E, Donatacci L, et al. Adherence to enfuvirtide and its impact on treatment efficacy. AIDS Res Hum Retroviruses. 2008;24:141-8.
    [PubMed Abstract]
  • Sax PE, Losina E, Weinstein MC, et al. Cost-effectiveness of enfuvirtide in treatment-experienced patients with advanced HIV disease. J Acquir Immune Defic Syndr. 2005;39:69-77.
    [PubMed Abstract]
  • Trottier B, Walmsley S, Reynes J, et al. Safety of enfuvirtide in combination with an optimized background of antiretrovirals in treatment-experienced HIV-1-infected adults over 48 weeks. J Acquir Immune Defic Syndr. 2005;40:413-21.
    [PubMed Abstract]
  • Walmsley S, Henry K, Katlama C, et al. Enfuvirtide (T-20) cross-reactive glycoprotein 41 antibody does not impair the efficacy or safety of enfuvirtide. J Infect Dis. 2003;188:1827-33.
    [PubMed Abstract]

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