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Common TitleBENCHMRK 1 and 2
Official Title A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety and Antiretroviral Activity of Raltegravir (MK-0518) in Combination With an Optimized Background Therapy (OBT), Versus Optimized Background Therapy Alone, in HIV-Infected Patients With Documented Resistance to at Least 1 Drug in Each of the 3 Classes of Licensed Oral Antiviral Therapies
Phase Phase III
ClinicalTrials.gov NCT00293267
Treatments
Raltegravir
Raltegravir Isentress

Raltegravir

Tradename:IsentressOther Names:RALClass:Integrase Inhibitors (INSTI)
Categories Resistance/Virological FailureTreatment-ExperiencedSwitch/SimplificationTreatment-Naive
Funding
IndustryMerck Sharp & Dohme Corp
References
  • Cooper DA, Steigbigel RT, Gatell JM, et al. Subgroup and resistance analyses of raltegravir for resistant HIV-1 infection. N Engl J Med. 2008;359:355-65.
    [PubMed Abstract]
  • Eron JJ, Cooper DA, Steigbigel RT, et al. Association between first-year virological response to raltegravir and long-term outcomes in treatment-experienced patients with HIV-1 infection. Antivir Ther. 2015;20:307-15.
    [PubMed Abstract]
  • Eron JJ, Cooper DA, Steigbigel RT, et al. Efficacy and safety of raltegravir for treatment of HIV for 5 years in the BENCHMRK studies: final results of two randomised, placebo-controlled trials. Lancet Infect Dis. 2013;13:587-96.
    [PubMed Abstract]
  • Rockstroh J, Teppler H, Zhao J, et al. Safety and efficacy of raltegravir in patients with HIV-1 and hepatitis B and/or C virus coinfection. HIV Med. 2012;13:127-31.
    [PubMed Abstract]
  • Steigbigel RT, Cooper DA, Kumar PN, et al. Raltegravir with optimized background therapy for resistant HIV-1 infection. N Engl J Med. 2008;359:339-54.
    [PubMed Abstract]
  • Steigbigel RT, Cooper DA, Teppler H, et al. Long-term efficacy and safety of Raltegravir combined with optimized background therapy in treatment-experienced patients with drug-resistant HIV infection: week 96 results of the BENCHMRK 1 and 2 Phase III trials. Clin Infect Dis. 2010;50:605-12.
    [PubMed Abstract]

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