Bictegravir-Tenofovir alafenamide-Emtricitabine Biktarvy
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Tenofovir alafenamide-Emtricitabine Descovy
Tenofovir DF-Emtricitabine Truvada and Multiple Generics
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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, Non CCR5-Tropic HIV-1 Infected Subjects
Phase Phase III
ClinicalTrials.gov NCT00098748
Treatments
Maraviroc
Maraviroc
Tradename:SelzentryOther Names:MVCClass:Entry InhibitorsCategories Resistance/Virological FailureTreatment-Experienced
Funding
IndustryViiV Healthcare
References
- 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.
- Saag M, Goodrich J, Fätkenheuer G, et al. A double-blind, placebo-controlled trial of maraviroc in treatment-experienced patients infected with non-R5 HIV-1. J Infect Dis. 2009;199:1638-47.
Official Title Pilot Study Of Novel Combination Of Maraviroc + Atazanavir/Ritonavir vs. Atazanavir/Ritonavir + Emtricitabine/Tenofovir For The Treatment Of Naïve HIV-Infected Patients With R5 HIV-1
Phase Phase II
ClinicalTrials.gov NCT00827112
Treatments
Maraviroc
, Maraviroc
Tradename:SelzentryOther Names:MVCClass:Entry InhibitorsAtazanavir
Atazanavir
Tradename:ReyatazOther Names:ATVClass:Protease Inhibitors (PI)Categories Treatment-NaiveDual Therapy
Funding
IndustryViiV Healthcare
References
- Mills A, Mildvan D, Podzamczer D, et al. Maraviroc once-daily nucleoside analog-sparing regimen in treatment-naive patients: randomized, open-label pilot study. J Acquir Immune Defic Syndr. 2013;62:164-70.
Official Title A Pilot Trial of Maraviroc for Treatment of Subjects on Antiretroviral Therapy With Suboptimal CD4 T-cell Count Recovery Despite Sustained Virologic Suppression
ClinicalTrials.gov NCT00709111
Treatments
Maraviroc
Maraviroc
Tradename:SelzentryOther Names:MVCClass:Entry InhibitorsCategories Treatment-Experienced
Funding
Non-IndustryNational Institute of Allergy and Infectious Diseases (NIAID)
References
- Wilkin TJ, Lalama CM, McKinnon J, et al. A pilot trial of adding maraviroc to suppressive antiretroviral therapy for suboptimal CD4⁺ T-cell recovery despite sustained virologic suppression: ACTG A5256. J Infect Dis. 2012;206:534-42.
Official Title A Phase 2b, Double-Blind, Placebo-Controlled, Exploratory Randomized Trial to Determine the Bone, Immunologic, Virologic, and Neurocognitive Effects of a Novel Maraviroc-Containing Antiretroviral Regimen in Treatment-Naïve Patients Infected With R5-Tropic HIV-1
Phase Phase II
ClinicalTrials.gov NCT01400412
Treatments
Maraviroc
, Maraviroc
Tradename:SelzentryOther Names:MVCClass:Entry InhibitorsTenofovir DF
Tenofovir DF
Tradename:VireadOther Names:TDF, tenofovir disoproxil fumarateClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Categories PharmacologyTreatment-NaiveAdverse Effects
Funding
Non-IndustryNational Institute of Allergy and Infectious Diseases (NIAID)
References
- Taiwo BO, Chan ES, Fichtenbaum CJ, et al. Less Bone Loss With Maraviroc- Versus Tenofovir-Containing Antiretroviral Therapy in the AIDS Clinical Trials Group A5303 Study. Clin Infect Dis. 2015;61:1179-88.
Official Title A Phase II Randomized, Double-Blind, Study of the Safety and Tolerability of Maraviroc (MVC), Maraviroc + Emtricitabine (MVC+FTC), Maraviroc + Tenofovir Disoproxil Fumarate (MVC+TDF), or Tenofovir Disoproxil Fumarate + Emtricitabine (TDF+FTC) For Pre-Exposure Prophylaxis (PrEP) To Prevent HIV Transmission in At-Risk Men Who Have Sex With Men and in At-Risk Women
Phase Phase II
ClinicalTrials.gov NCT01505114
Treatments
Maraviroc
Maraviroc
Tradename:SelzentryOther Names:MVCClass:Entry InhibitorsCategories PREP
Funding
Non-IndustryNational Institute of Allergy and Infectious Diseases (NIAID)
References
- Gulick RM, Wilkin TJ, Chen YQ, et al. Phase 2 Study of the Safety and Tolerability of Maraviroc-Containing Regimens to Prevent HIV Infection in Men Who Have Sex With Men (HPTN 069/ACTG A5305). J Infect Dis. 2017;215:238-246.
Official Title Open Randomized Study Comparing Two Alternatives of Antiretroviral Therapy as Post-exposure Prophylaxis to HIV-1: TENOFOVIR+EMTRICITABINA + LOPINAVIR/RITONAVIR VS TENOFOVIR+EMTRICITABINA + MARAVIROC
Phase Phase IV
ClinicalTrials.gov NCT01533272
Treatments
Maraviroc
, Maraviroc
Tradename:SelzentryOther Names:MVCClass:Entry InhibitorsLopinavir-Ritonavir
Lopinavir-Ritonavir
Tradename:KaletraOther Names:LPV-RTVClass:Protease Inhibitors (PI)Categories PharmacologyAdverse EffectsPEP
Funding
Non-IndustryHospital Clinic of Barcelona
References
- Leal L, León A, Torres B, et al. A randomized clinical trial comparing ritonavir-boosted lopinavir versus maraviroc each with tenofovir plus emtricitabine for post-exposure prophylaxis for HIV infection. J Antimicrob Chemother. 2016;71:1982-6.
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 InhibitorsZidovudine-Lamivudine
Zidovudine-Lamivudine
Tradename:CombivirOther Names:ZDV-3TCClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Categories 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
Darunavir
, Darunavir
Tradename:PrezistaOther Names:DRVClass:Protease Inhibitors (PI)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.
Official Title Phase II Pilot Study Evaluating the Efficacy of Dual Therapy With Raltegravir Plus Maraviroc in Patients Receiving Suppressive Antiretroviral Therapy and Presenting With Lipohypertrophy (ANRS 157 ROCnRAL)
Phase Phase II
ClinicalTrials.gov NCT01420523
Treatments
Raltegravir
, Raltegravir
Tradename:IsentressOther Names:RALClass:Integrase Inhibitors (INSTI)Maraviroc
Maraviroc
Tradename:SelzentryOther Names:MVCClass:Entry InhibitorsCategories PharmacologySwitch/SimplificationAdverse EffectsDual Therapy
Funding
Non-IndustryFrench National Agency for Research on AIDS and Viral Hepatitis
References
- Katlama C, Assoumou L, Valantin MA, et al. Maraviroc plus raltegravir failed to maintain virological suppression in HIV-infected patients with lipohypertrophy: results from the ROCnRAL ANRS 157 study. J Antimicrob Chemother. 2014;69:1648-52.
- Soulié C, Assoumou L, Darty M, et al. Virological factors associated with outcome of dual maraviroc/raltegravir therapy (ANRS-157 trial). J Antimicrob Chemother. 2015;70:3339-44.
Maraviroc Slide Deck
July 26, 2020
Clinical Trial Image Decks
A4001029 - July 6, 2017
A4001078 - July 6, 2017
ACTG 5256 - May 24, 2019
A5303 - July 6, 2017
HPTN 069/ACTG 5305 - July 7, 2017
MARAVI-PEP - July 5, 2017
MARCH - July 6, 2017
MERIT - July 6, 2017
MOTIVATE 1 - July 6, 2017
MOTIVATE 2 - July 6, 2017
OPTIPRIM - February 21, 2020
ROCnRAL - February 21, 2020