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Official Title Randomised, Open-label Study Evaluating Efficacy and Safety of Maraviroc as a Switch for Either NRTI or PI/r in HIV-1 Infected Individuals With Stable, Well‐Controlled Plasma HIV‐RNA While Taking Their First N(t)RTI + PI/r Regimen of cART
Phase Phase IV
ClinicalTrials.gov NCT01384682
Treatments
Maraviroc
Maraviroc
Tradename:SelzentryOther Names:MVCClass:Entry InhibitorsCategories Switch/SimplificationDual TherapyTreatment-Experienced
Funding
IndustryViiV Healthcare
References
- Pett SL, Amin J, Horban A, et al. Maraviroc, as a Switch Option, in HIV-1-infected Individuals With Stable, Well-controlled HIV Replication and R5-tropic Virus on Their First Nucleoside/Nucleotide Reverse Transcriptase Inhibitor Plus Ritonavir-boosted Protease Inhibitor Regimen: Week 48 Results of the Randomized, Multicenter MARCH Study. Clin Infect Dis. 2016;63:122-32.
- Tu E, Swenson LC, Land S, et al. Results of external quality assessment for proviral DNA testing of HIV tropism in the Maraviroc Switch collaborative study. J Clin Microbiol. 2013;51:2063-71.
Official Title A Multicenter, Randomized, Double-Blind, Comparative Trial Of A Novel CCR5 Antagonist, UK-427,857, In Combination With Zidovudine/Lamivudine Versus Efavirenz In Combination With Zidovudine/Lamivudine For The Treatment Of Antiretroviral-Naive HIV-1 Infected Subjects
Phase Phase III
ClinicalTrials.gov NCT00098293
Treatments
Maraviroc
Maraviroc
Tradename:SelzentryOther Names:MVCClass:Entry InhibitorsCategories Treatment-NaivePharmacologyAdverse Effects
Funding
IndustryViiV Healthcare
References
- Cooper DA, Heera J, Goodrich J, et al. Maraviroc versus efavirenz, both in combination with zidovudine-lamivudine, for the treatment of antiretroviral-naive subjects with CCR5-tropic HIV-1 infection. J Infect Dis. 2010;201:803-13.
- Cooper DA, Heera J, Ive P, et al. Efficacy and safety of maraviroc vs. efavirenz in treatment-naive patients with HIV-1: 5-year findings. AIDS. 2014;28:717-25.
- Funderburg N, Kalinowska M, Eason J, et al. Effects of maraviroc and efavirenz on markers of immune activation and inflammation and associations with CD4+ cell rises in HIV-infected patients. PLoS One. 2010;5:e13188.
- MacInnes A, Lazzarin A, Di Perri G, et al. Maraviroc can improve lipid profiles in dyslipidemic patients with HIV: results from the MERIT trial. HIV Clin Trials. 2011;12:24-36.
- McGovern RA, Thielen A, Portsmouth S, et al. Population-based sequencing of the V3-loop can predict the virological response to maraviroc in treatment-naive patients of the MERIT trial. J Acquir Immune Defic Syndr. 2012;61:279-86.
- Sierra-Madero J, Di Perri G, Wood R, et al. Efficacy and safety of maraviroc versus efavirenz, both with zidovudine/lamivudine: 96-week results from the MERIT study. HIV Clin Trials. 2010;11:125-32.
- Swenson LC, Mo T, Dong WW, et al. Deep V3 sequencing for HIV type 1 tropism in treatment-naive patients: a reanalysis of the MERIT trial of maraviroc. Clin Infect Dis. 2011;53:732-42.
Official Title A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of a Novel CCR5 Antagonist, Maraviroc (UK-427,857), in Combination With Optimized Background Therapy Versus Optimized Background Therapy Alone for the Treatment of Antiretroviral-Experienced HIV-1 Infected Subjects.
Phase Phase III
ClinicalTrials.gov NCT00098306
Treatments
Maraviroc
Maraviroc
Tradename:SelzentryOther Names:MVCClass:Entry InhibitorsCategories Resistance/Virological FailureTreatment-ExperiencedPharmacologyAdverse EffectsGeneral Pharmacology
Funding
IndustryViiV Healthcare
References
- Asmuth DM, Goodrich J, Cooper DA, et al. CD4+ T-cell restoration after 48 weeks in the maraviroc treatment-experienced trials MOTIVATE 1 and 2. J Acquir Immune Defic Syndr. 2010;54:394-7.
- Fätkenheuer G, Nelson M, Lazzarin A, et al. Subgroup analyses of maraviroc in previously treated R5 HIV-1 infection. N Engl J Med. 2008;359:1442-55.
- Gulick RM, Fatkenheuer G, Burnside R, et al. Five-year safety evaluation of maraviroc in HIV-1-infected treatment-experienced patients. J Acquir Immune Defic Syndr. 2014;65:78-81.
- Gulick RM, Lalezari J, Goodrich J, et al. Maraviroc for previously treated patients with R5 HIV-1 infection. N Engl J Med. 2008;359:1429-41.
- Hardy WD, Gulick RM, Mayer H, et al. Two-year safety and virologic efficacy of maraviroc in treatment-experienced patients with CCR5-tropic HIV-1 infection: 96-week combined analysis of MOTIVATE 1 and 2. J Acquir Immune Defic Syndr. 2010;55:558-64.
- Jacqmin P, Wade JR, Weatherley B, Snoeck E, Marshall S, McFadyen L. Assessment of Maraviroc Exposure-Response Relationship at 48 Weeks in Treatment-Experienced HIV-1-Infected Patients in the MOTIVATE Studies. CPT Pharmacometrics Syst Pharmacol. 2013;2:e64.
- Jiang X, Feyertag F, Meehan CJ, et al. Characterizing the Diverse Mutational Pathways Associated with R5-Tropic Maraviroc Resistance: HIV-1 That Uses the Drug-Bound CCR5 Coreceptor. J Virol. 2015;89:11457-72.
- McGovern RA, Thielen A, Mo T, et al. Population-based V3 genotypic tropism assay: a retrospective analysis using screening samples from the A4001029 and MOTIVATE studies. AIDS. 2010;24:2517-25.
- Swenson LC, Chui CK, Brumme CJ, et al. Genotypic analysis of the V3 region of HIV from virologic nonresponders to maraviroc-containing regimens reveals distinct patterns of failure. Antimicrob Agents Chemother. 2013;57:6122-30.
- van Lelyveld SF, Wensing AM, Hoepelman AI. The MOTIVATE trials: maraviroc therapy in antiretroviral treatment-experienced HIV-1-infected patients. Expert Rev Anti Infect Ther. 2012;10:1241-7.
Official Title A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of a Novel CCR5 Antagonist, UK-427,857, in Combination With Optimized Background Therapy Versus Optimized Background Therapy Alone for the Treatment of Antiretroviral-Experienced HIV-1 Infected Subjects
Phase Phase III
ClinicalTrials.gov NCT00098722
Treatments
Maraviroc
Maraviroc
Tradename:SelzentryOther Names:MVCClass:Entry InhibitorsCategories Resistance/Virological FailureTreatment-ExperiencedTreatment-NaiveMonotherapyPharmacologyAdverse EffectsGeneral Pharmacology
Funding
IndustryViiV Healthcare
References
- Asmuth DM, Goodrich J, Cooper DA, et al. CD4+ T-cell restoration after 48 weeks in the maraviroc treatment-experienced trials MOTIVATE 1 and 2. J Acquir Immune Defic Syndr. 2010;54:394-7.
- Fätkenheuer G, Pozniak AL, Johnson MA, et al. Efficacy of short-term monotherapy with maraviroc, a new CCR5 antagonist, in patients infected with HIV-1. Nat Med. 2005;11:1170-2.
- Gulick RM, Fatkenheuer G, Burnside R, et al. Five-year safety evaluation of maraviroc in HIV-1-infected treatment-experienced patients. J Acquir Immune Defic Syndr. 2014;65:78-81.
- Gulick RM, Lalezari J, Goodrich J, et al. Maraviroc for previously treated patients with R5 HIV-1 infection. N Engl J Med. 2008;359:1429-41.
- Hardy WD, Gulick RM, Mayer H, et al. Two-year safety and virologic efficacy of maraviroc in treatment-experienced patients with CCR5-tropic HIV-1 infection: 96-week combined analysis of MOTIVATE 1 and 2. J Acquir Immune Defic Syndr. 2010;55:558-64.
- Jacqmin P, Wade JR, Weatherley B, Snoeck E, Marshall S, McFadyen L. Assessment of Maraviroc Exposure-Response Relationship at 48 Weeks in Treatment-Experienced HIV-1-Infected Patients in the MOTIVATE Studies. CPT Pharmacometrics Syst Pharmacol. 2013;2:e64.
- Jiang X, Feyertag F, Meehan CJ, et al. Characterizing the Diverse Mutational Pathways Associated with R5-Tropic Maraviroc Resistance: HIV-1 That Uses the Drug-Bound CCR5 Coreceptor. J Virol. 2015;89:11457-72.
- McGovern RA, Thielen A, Mo T, et al. Population-based V3 genotypic tropism assay: a retrospective analysis using screening samples from the A4001029 and MOTIVATE studies. AIDS. 2010;24:2517-25.
Official Title Optimisation of Primary HIV1 Infection Treatment (ANRS 147 OPTIPRIM)
Phase Phase III
ClinicalTrials.gov NCT01033760
Treatments
Raltegravir
, Raltegravir
Tradename:IsentressOther Names:RALClass:Integrase Inhibitors (INSTI)Maraviroc
Maraviroc
Tradename:SelzentryOther Names:MVCClass:Entry InhibitorsCategories Treatment-NaiveAcute HIV
Funding
Non-IndustryFrench National Agency for Research on AIDS and Viral Hepatitis
References
- Chéret A, Nembot G, Mélard A, et al. Intensive five-drug antiretroviral therapy regimen versus standard triple-drug therapy during primary HIV-1 infection (OPTIPRIM-ANRS 147): a randomised, open-label, phase 3 trial. Lancet Infect Dis. 2015;15:387-96.