Bictegravir-Tenofovir alafenamide-Emtricitabine Biktarvy
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Dolutegravir-Abacavir-Lamivudine Triumeq
Dolutegravir-Lamivudine Dovato
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Elvitegravir-Cobicistat-Tenofovir alafenamide-Emtricitabine Genvoya
Elvitegravir-Cobicistat-Tenofovir DF-Emtricitabine Stribild
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Rilpivirine-Tenofovir DF-Emtricitabine Complera
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Tenofovir DF-Emtricitabine Truvada and Multiple Generics
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Official Title Multicenter Study to Evaluate the Safety and Efficacy of Raltegravir (MK0518) in Combination With An Optimized Background Therapy (OBT), Versus OBT Alone, in HIV-Infected Patients With Documented Resistance
Phase Phase II
ClinicalTrials.gov NCT00105157
Treatments
Raltegravir
Raltegravir
Tradename:IsentressOther Names:RALClass:Integrase Inhibitors (INSTI)Categories Resistance/Virological FailureTreatment-Experienced
Funding
IndustryMerck Sharp & Dohme Corp
References
- Grinsztejn B, Nguyen BY, Katlama C, et al. Safety and efficacy of the HIV-1 integrase inhibitor raltegravir (MK-0518) in treatment-experienced patients with multidrug-resistant virus: a phase II randomised controlled trial. Lancet. 2007;369:1261-9.
Official Title A Double-Blind, Randomized, Pilot Study to Measure the Effect of Treatment Intensification With a Potent Integrase Inhibitor, Raltegravir (MK-0518), on the Level of Persistent Plasma Viremia Below 50 Copies/ml in Subjects on Protease Inhibitor- or Non-Nucleoside Reverse Transcriptase Inhibitor-Containing Regimens
Phase Phase II
ClinicalTrials.gov NCT00515827
Treatments
Raltegravir
Raltegravir
Tradename:IsentressOther Names:RALClass:Integrase Inhibitors (INSTI)Categories Treatment-Experienced
Funding
Non-IndustryNational Institute of Allergy and Infectious Diseases (NIAID)
References
- Gandhi RT, Zheng L, Bosch RJ, et al. The effect of raltegravir intensification on low-level residual viremia in HIV-infected patients on antiretroviral therapy: a randomized controlled trial. PLoS Med. 2010;7:e1000321.
Official Title Cardiovascular, Anthropometric, and Skeletal Effects of Antiretroviral Therapy (ART) Initiation With Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) Plus Atazanavir/Ritonavir (ATV/r), Darunavir/Ritonavir (DRV/r), or Raltegravir (RAL): Metabolic Substudy of A5257
Phase Phase III
ClinicalTrials.gov NCT00851799
Treatments
Darunavir
, Darunavir
Tradename:PrezistaOther Names:DRVClass:Protease Inhibitors (PI)Raltegravir
, Raltegravir
Tradename:IsentressOther Names:RALClass:Integrase Inhibitors (INSTI)Atazanavir
Atazanavir
Tradename:ReyatazOther Names:ATVClass:Protease Inhibitors (PI)Categories Treatment-NaiveAdverse Effects
Funding
Non-IndustryNational Institute of Allergy and Infectious Diseases (NIAID)
References
- Brown TT, Moser C, Currier JS, et al. Changes in Bone Mineral Density After Initiation of Antiretroviral Treatment With Tenofovir Disoproxil Fumarate/Emtricitabine Plus Atazanavir/Ritonavir, Darunavir/Ritonavir, or Raltegravir. J Infect Dis. 2015;212:1241-9.
- Kelesidis T, Moser C, Stein JH, et al. Changes in Markers of T-Cell Senescence and Exhaustion With Atazanavir-, Raltegravir-, and Darunavir-Based Initial Antiviral Therapy: ACTG 5260s. J Infect Dis. 2016;214:748-52.
- McComsey GA, Moser C, Currier J, et al. Body Composition Changes After Initiation of Raltegravir or Protease Inhibitors: ACTG A5260s. Clin Infect Dis. 2016;62:853-62.
Official Title A Pilot Efficacy and Safety Trial of Raltegravir Plus Darunavir/Ritonavir for Treatment-Naive HIV-1-Infected Subjects
Phase Phase II
ClinicalTrials.gov NCT00830804
Treatments
Darunavir
, Darunavir
Tradename:PrezistaOther Names:DRVClass:Protease Inhibitors (PI)Raltegravir
Raltegravir
Tradename:IsentressOther Names:RALClass:Integrase Inhibitors (INSTI)Categories Treatment-NaiveDual Therapy
Funding
Non-IndustryNational Institute of Allergy and Infectious Diseases (NIAID)
References
- Taiwo B, Zheng L, Gallien S, et al. Efficacy of a nucleoside-sparing regimen of darunavir/ritonavir plus raltegravir in treatment-naive HIV-1-infected patients (ACTG A5262). AIDS. 2011;25:2113-22.
Official Title The ARDENT Study: Atazanavir, Raltegravir, or Darunavir With Emtricitabine/Tenofovir for Naive Treatment
Phase Phase III
ClinicalTrials.gov NCT00811954
Treatments
Darunavir
, Darunavir
Tradename:PrezistaOther Names:DRVClass:Protease Inhibitors (PI)Raltegravir
, Raltegravir
Tradename:IsentressOther Names:RALClass:Integrase Inhibitors (INSTI)Atazanavir
, Atazanavir
Tradename:ReyatazOther Names:ATVClass:Protease Inhibitors (PI)Ritonavir
Ritonavir
Tradename:NorvirOther Names:RTVClass:Pharmacokinetic EnhancersCategories Treatment-NaiveAdverse Effects
Funding
Non-IndustryNational Institute of Allergy and Infectious Diseases (NIAID)
References
- Lennox JL, Landovitz RJ, Ribaudo HJ, et al. Efficacy and tolerability of 3 nonnucleoside reverse transcriptase inhibitor-sparing antiretroviral regimens for treatment-naive volunteers infected with HIV-1: a randomized, controlled equivalence trial. Ann Intern Med. 2014;161:461-71.
- Ofotokun I, Na LH, Landovitz RJ, et al. Comparison of the metabolic effects of ritonavir-boosted darunavir or atazanavir versus raltegravir, and the impact of ritonavir plasma exposure: ACTG 5257. Clin Infect Dis. 2015;60:1842-51.
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
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.
- 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.
- 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.
- 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.
- 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.
- 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.
Official Title Virologic Outcomes of Changing Enfuvirtide to Raltegravir in HIV-1 Patients Well Controlled on an Enfuvirtide Based Regimen
Phase Phase III
ClinicalTrials.gov NCT00529243
Treatments
Raltegravir
, Raltegravir
Tradename:IsentressOther Names:RALClass:Integrase Inhibitors (INSTI)Enfuvirtide
Enfuvirtide
Tradename:FuzeonOther Names:T-20Class:Entry InhibitorsCategories Treatment-ExperiencedSwitch/Simplification
Funding
Non-IndustryKaiser Permanente
References
- Towner W, Klein D, Kerrigan HL, Follansbee S, Yu K, Horberg M. Virologic outcomes of changing enfuvirtide to raltegravir in HIV-1 patients well controlled on an enfuvirtide based regimen: 24-week results of the CHEER study. J Acquir Immune Defic Syndr. 2009;51:367-73.
Official Title Randomized Non-inferiority Study Comparing a Strategy Maintaining Current Enfuvirtide-based Antiretroviral Therapy to a Strategy Replacing Enfuvirtide by an Integrase Inhibitor (Raltegravir) in HIV-1 Infected Subjects With Plasma Hiv-1 RNA Levels Below 400 Copies Per ml.ANRS 138 EASIER
Phase Phase III
ClinicalTrials.gov NCT00454337.
Treatments
Raltegravir
, Raltegravir
Tradename:IsentressOther Names:RALClass:Integrase Inhibitors (INSTI)Enfuvirtide
Enfuvirtide
Tradename:FuzeonOther Names:T-20Class:Entry InhibitorsCategories PharmacologyTreatment-ExperiencedSwitch/SimplificationAdverse Effects
Funding
Non-IndustryFrench National Agency for Research on AIDS and Viral Hepatitis
References
- de Castro N, Braun J, Charreau I, et al. Incidence and risk factors for liver enzymes elevations in highly treatment-experienced patients switching from enfuvirtide to raltegravir: a sub-study of the ANRS-138 EASIER trial. AIDS Res Ther. 2016;13:17.
- De Castro N, Braun J, Charreau I, et al. Switch from enfuvirtide to raltegravir in virologically suppressed multidrug-resistant HIV-1-infected patients: a randomized open-label trial. Clin Infect Dis. 2009;49:1259-67.
- Gallien S, Braun J, Delaugerre C, et al. Efficacy and safety of raltegravir in treatment-experienced HIV-1-infected patients switching from enfuvirtide-based regimens: 48 week results of the randomized EASIER ANRS 138 trial. J Antimicrob Chemother. 2011;66:2099-106.
Official Title A Multicenter, Randomized, Double-Blind, Double-Dummy, Phase 3 Study of the Safety and Efficacy of Ritonavir-Boosted Elvitegravir (EVG/r) Versus Raltegravir (RAL) Each Administered With a Background Regimen in HIV-1 Infected, Antiretroviral Treatment-Experienced Adults
Phase Phase III
ClinicalTrials.gov NCT00708162
Treatments
Raltegravir
Raltegravir
Tradename:IsentressOther Names:RALClass:Integrase Inhibitors (INSTI)Categories Resistance/Virological FailureTreatment-ExperiencedSwitch/Simplification
Funding
IndustryGilead Sciences
References
- Molina JM, Lamarca A, Andrade-Villanueva J, et al. Efficacy and safety of once daily elvitegravir versus twice daily raltegravir in treatment-experienced patients with HIV-1 receiving a ritonavir-boosted protease inhibitor: randomised, double-blind, phase 3, non-inferiority study. Lancet Infect Dis. 2012;12:27-35.
Official Title An Open-Label, Randomized Study Evaluating a Switch From a Regimen of Two Nucleoside Reverse Transcriptase Inhibitors Regimen Plus Any Third Agent to Either a Regimen of Atazanavir/Ritonavir Once Daily and Raltegravir Twice Daily or to a Regimen of Atazanavir/Ritonavir Once Daily and Tenofovir/Emtricitabine Once Daily in Virologically Suppressed HIV-1 Infected Subjects With Safety and/or Tolerability Issues on Their Present Treatment Regimen.
Phase Phase IV
ClinicalTrials.gov NCT01332227
Treatments
Raltegravir
, Raltegravir
Tradename:IsentressOther Names:RALClass:Integrase Inhibitors (INSTI)Atazanavir
Atazanavir
Tradename:ReyatazOther Names:ATVClass:Protease Inhibitors (PI)Categories Treatment-ExperiencedSwitch/SimplificationDual Therapy
Funding
IndustryBristol-Myers Squibb
References
- van Lunzen J, Pozniak A, Gatell JM, et al. Brief Report: Switch to Ritonavir-Boosted Atazanavir Plus Raltegravir in Virologically Suppressed Patients With HIV-1 Infection: A Randomized Pilot Study. J Acquir Immune Defic Syndr. 2016;71:538-43.
Official Title An Open-label Randomised Two-year Trial Comparing Two First-line Regimens in HIV-infected Antiretroviral naïve Subjects: Darunavir/r plus Tenofovir/Emtricitabine vs. Darunavir/r plus Raltegravir (ANRS 143/NEAT 001)
Phase Phase III
ClinicalTrials.gov NCT01066962
Treatments
Darunavir
, Darunavir
Tradename:PrezistaOther Names:DRVClass:Protease Inhibitors (PI)Raltegravir
Raltegravir
Tradename:IsentressOther Names:RALClass:Integrase Inhibitors (INSTI)Categories Treatment-NaiveAdverse EffectsDual TherapyResistance/Virological Failure
Funding
IndustryGilead Sciences, Janssen Pharmaceuticals, Mer
Non-IndustryEuropean Union Sixth Framework Programme, Inserm-ANRS
References
- Bernardino JI, Mocroft A, Mallon PW, et al. Bone mineral density and inflammatory and bone biomarkers after darunavir-ritonavir combined with either raltegravir or tenofovir-emtricitabine in antiretroviral-naive adults with HIV-1: a substudy of the NEAT001/ANRS143 randomised trial. Lancet HIV. 2015;2:e464-73.
- Lambert-Niclot S, George EC, Pozniak A, et al. Antiretroviral resistance at virological failure in the NEAT 001/ANRS 143 trial: raltegravir plus darunavir/ritonavir or tenofovir/emtricitabine plus darunavir/ritonavir as first-line ART. J Antimicrob Chemother. 2016;71:1056-62.
- Raffi F, Babiker AG, Richert L, et al. Ritonavir-boosted darunavir combined with raltegravir or tenofovir-emtricitabine in antiretroviral-naive adults infected with HIV-1: 96 week results from the NEAT001/ANRS143 randomised non-inferiority trial. Lancet. 2014;384:1942-51.
Official Title A Phase III Multicenter, Double-Blind, Randomized, Active Comparator-Controlled Clinical Trial to Evaluate the Safety and Efficacy of Reformulated Raltegravir 1200 mg Once Daily Versus Raltegravir 400 mg Twice Daily, Each in Combination With TRUVADA™, in Treatment-Naïve HIV-1 Infected Subjects
Phase Phase III
ClinicalTrials.gov NCT02131233
Treatments
Raltegravir
Raltegravir
Tradename:IsentressOther Names:RALClass:Integrase Inhibitors (INSTI)Categories Treatment-Naive
Funding
IndustryMerck Sharp & Dohme Corp
References
- Cahn P, Kaplan R, Sax PE, et al. Raltegravir 1200 mg once daily versus raltegravir 400 mg twice daily, with tenofovir disoproxil fumarate and emtricitabine, for previously untreated HIV-1 infection: a randomised, double-blind, parallel-group, phase 3, non-inferiority trial. Lancet HIV. 2017;4:e486-e494.
- Cahn P, Sax PE, Squires K, et al. Raltegravir 1200 mg Once Daily vs 400 mg Twice Daily, With Emtricitabine and Tenofovir Disoproxil Fumarate, for Previously Untreated HIV-1 Infection: Week 96 Results From ONCEMRK, a Randomized, Double-Blind, Noninferiority Trial. J Acquir Immune Defic Syndr. 2018;78:589-598.
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 Study on Pharmacokinetics of Newly Developed ANtiretroviral Agents in HIV-infected pregNAnt Women (PANNA)
Phase Phase IV
ClinicalTrials.gov NCT00825929
Treatments
Raltegravir
Raltegravir
Tradename:IsentressOther Names:RALClass:Integrase Inhibitors (INSTI)Categories PharmacologyPregnancy/WomenGeneral Pharmacology
Funding
Non-IndustryRadboud University
References
- Blonk MI, Colbers AP, Hidalgo-Tenorio C, et al. Raltegravir in HIV-1-Infected Pregnant Women: Pharmacokinetics, Safety, and Efficacy. Clin Infect Dis. 2015;61:809-16.
Official Title A Randomized, Open-label Study of Lopinavir/Ritonavir 400/100 mg Tablet Twice Daily + Co-formulated Emtricitabine/Tenofovir Disoproxil Fumarate 200/300 mg Once Daily Versus Lopinavir/Ritonavir 400/100 mg Tablet Twice Daily + Raltegravir 400 mg Twice Daily in Antiretroviral Naive, HIV-1 Infected Subjects
Phase Phase III
ClinicalTrials.gov NCT00711009
Treatments
Raltegravir
, Raltegravir
Tradename:IsentressOther Names:RALClass:Integrase Inhibitors (INSTI)Lopinavir-Ritonavir
Lopinavir-Ritonavir
Tradename:KaletraOther Names:LPV-RTVClass:Protease Inhibitors (PI)Categories Treatment-NaiveDual Therapy
Funding
IndustryAbbott
References
- Reynes J, Lawal A, Pulido F, et al. Examination of noninferiority, safety, and tolerability of lopinavir/ritonavir and raltegravir compared with lopinavir/ritonavir and tenofovir/ emtricitabine in antiretroviral-naïve subjects: the progress study, 48-week results. HIV Clin Trials. 2011;12:255-67.
- Reynes J, Trinh R, Pulido F, et al. Lopinavir/ritonavir combined with raltegravir or tenofovir/emtricitabine in antiretroviral-naive subjects: 96-week results of the PROGRESS study. AIDS Res Hum Retroviruses. 2013;29:256-65.
Official Title A Phase III Multicenter, Double-Blind, Randomized, Active Comparator-Controlled Clinical Trial to Study the Safety and Efficacy of Once Daily Raltegravir (MK0518) Versus Twice Daily Raltegravir, Each in Combination With TRUVADA™, in Treatment-Naïve HIV Infected Patients
Phase Phase III
ClinicalTrials.gov NCT00745823
Treatments
Raltegravir
Raltegravir
Tradename:IsentressOther Names:RALClass:Integrase Inhibitors (INSTI)Categories Treatment-Naive
Funding
IndustryMerck Sharp & Dohme Corp
References
- Eron JJ Jr, Rockstroh JK, Reynes J, et al. Raltegravir once daily or twice daily in previously untreated patients with HIV-1: a randomised, active-controlled, phase 3 non-inferiority trial. Lancet Infect Dis. 2011;11:907-15.
Official Title Evaluation of Safety and Efficacy of Raltegravir/Darunavir Combination in Antiretroviral-Naive Patients
Phase Phase IV
ClinicalTrials.gov NCT00677300
Treatments
Darunavir
, Darunavir
Tradename:PrezistaOther Names:DRVClass:Protease Inhibitors (PI)Raltegravir
Raltegravir
Tradename:IsentressOther Names:RALClass:Integrase Inhibitors (INSTI)Categories Treatment-NaiveAdverse EffectsDual Therapy
Funding
IndustryMerck & Co.; Janssen
References
- Bedimo RJ, Drechsler H, Jain M, et al. The RADAR study: week 48 safety and efficacy of RAltegravir combined with boosted DARunavir compared to tenofovir/emtricitabine combined with boosted darunavir in antiretroviral-naive patients. Impact on bone health. PLoS One. 2014;9:e106221.
Official Title Open Randomized Study Comparing Two Alternatives of Antiretroviral Therapy as Post-exposure Prophylaxis to HIV-1: Tenofovir + Emtricitabine + Lopinavir/Ritonavir Versus Tenofovir + Emtricitabine + Raltegravir
Phase Phase IV
ClinicalTrials.gov NCT01576731
Treatments
Raltegravir
, Raltegravir
Tradename:IsentressOther Names:RALClass:Integrase Inhibitors (INSTI)Lopinavir-Ritonavir
Lopinavir-Ritonavir
Tradename:KaletraOther Names:LPV-RTVClass:Protease Inhibitors (PI)Categories PEP
Funding
Non-IndustryHospital Clinic of Barcelona
References
- Leal L, León A, Torres B, et al. A randomized clinical trial comparing ritonavir-boosted lopinavir versus raltegravir each with tenofovir plus emtricitabine for post-exposure prophylaxis for HIV infection. J Antimicrob Chemother. 2016;71:1987-93.
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.
Official Title A Randomized, Double-blind Study of the Safety and Efficacy of Dolutegravir (GSK1349572) 50 mg Once Daily Versus Raltegravir 400 mg Twice Daily, Both Administered With an Investigator-selected Background Regimen Over 48 Weeks in HIV-1 Infected, Integrase Inhibitor-Naïve, Antiretroviral-Experienced Adults
Phase Phase III
ClinicalTrials.gov NCT01231516
Treatments
Dolutegravir
, Dolutegravir
Tradename:TivicayOther Names:DTGClass:Integrase Inhibitors (INSTI)Raltegravir
Raltegravir
Tradename:IsentressOther Names:RALClass:Integrase Inhibitors (INSTI)Categories Resistance/Virological FailureTreatment-Experienced
Funding
IndustryViiV Healthcare
References
- Cahn P, Pozniak AL, Mingrone H, et al. Dolutegravir versus raltegravir in antiretroviral-experienced, integrase-inhibitor-naive adults with HIV: week 48 results from the randomised, double-blind, non-inferiority SAILING study. Lancet. 2013;382:700-8.
Official Title A Randomised Open-label Study Comparing the Safety and Efficacy of Ritonavir Boosted Lopinavir and 2-3N(t)RTI Backbone Versus Ritonavir Boosted Lopinavir and Raltegravir in Participants Virologically Failing First-line NNRTI/2N(t)RTI Therapy
Phase Phase IV
ClinicalTrials.gov NCT00931463
Treatments
Raltegravir
, Raltegravir
Tradename:IsentressOther Names:RALClass:Integrase Inhibitors (INSTI)Lopinavir-Ritonavir
Lopinavir-Ritonavir
Tradename:KaletraOther Names:LPV-RTVClass:Protease Inhibitors (PI)Funding
Non-IndustryKirby Institute
References
No references available for this clinical trial
Official Title Multicenter Study of Options for Second-Line Effective Combination Therapy (SELECT)
Phase Phase III
ClinicalTrials.gov NCT01352715
Treatments
Raltegravir
, Raltegravir
Tradename:IsentressOther Names:RALClass:Integrase Inhibitors (INSTI)Lopinavir-Ritonavir
Lopinavir-Ritonavir
Tradename:KaletraOther Names:LPV-RTVClass:Protease Inhibitors (PI)Categories Resistance/Virological FailureTreatment-ExperiencedDual Therapy
Funding
Non-IndustryNational Institute of Allergy and Infectious Diseases (NIAID)
References
- La Rosa AM, Harrison LJ, Taiwo B, et al. Raltegravir in second-line antiretroviral therapy in resource-limited settings (SELECT): a randomised, phase 3, non-inferiority study. Lancet HIV. 2016;3:e247-58.
Official Title A Pilot Study of Highly Active Antiretroviral Therapy Using Isentress (Raltegravir) and Epzicom (Abacavir/Lamivudine) in Antiretroviral Naive HIV-Infected Subjects
Phase Phase IV
ClinicalTrials.gov NCT00740064
Treatments
Raltegravir
Raltegravir
Tradename:IsentressOther Names:RALClass:Integrase Inhibitors (INSTI)Categories Treatment-Naive
Funding
Non-IndustryDenver Infectious Disease Consultants, PLLC
References
- Young B, Vanig T, DeJesus E, et al. 96-week results of a pilot study of abacavir/lamivudine and raltegravir in antiretroviral-naïve HIV-1-infected patients: the SHIELD trial. HIV Clin Trials. 2011;12:228-33.
- Young B, Vanig T, Dejesus E, et al. A pilot study of abacavir/lamivudine and raltegravir in antiretroviral-naïve HIV-1-infected patients: 48-week results of the SHIELD trial. HIV Clin Trials. 2010;11:260-9.
Official Title An Open-label, Randomized, 48-Week Study to Assess the Safety, Tolerability and Activity of Raltegravir When Replacing the Ritonavir-boosted PI Component of HAART in HIV-Infected Individuals With Viral Load Suppression on a Ritonavir-Boosted PI Containing Regimen.
Phase Phase III
ClinicalTrials.gov NCT00528892
Treatments
Raltegravir
Raltegravir
Tradename:IsentressOther Names:RALClass:Integrase Inhibitors (INSTI)Categories Treatment-ExperiencedSwitch/SimplificationPharmacologyAdverse Effects
Funding
Non-IndustryHospital Clinic of Barcelona
References
- Blanco JL, Gonzalez-Cordón A, Llibre JM, et al. Impact of prior virological failure and nucleos(t)ide genotypic resistance mutations on the efficacy of switching from ritonavir-boosted protease inhibitors to raltegravir. Antivir Ther. 2015;20:487-92.
- Curran A, Martinez E, Saumoy M, et al. Body composition changes after switching from protease inhibitors to raltegravir: SPIRAL-LIP substudy. AIDS. 2012;26:475-81.
- Martínez E, D'Albuquerque PM, Llibre JM, et al. Changes in cardiovascular biomarkers in HIV-infected patients switching from ritonavir-boosted protease inhibitors to raltegravir. AIDS. 2012;26:2315-26.
- Martínez E, Larrousse M, Llibre JM, et al. Substitution of raltegravir for ritonavir-boosted protease inhibitors in HIV-infected patients: the SPIRAL study. AIDS. 2010;24:1697-707.
- Masiá M, Martínez E, Padilla S, Gatell JM, Gutiérrez F. Endothelial function in HIV-infected patients switching from a boosted protease inhibitor-based regimen to raltegravir: a substudy of the SPIRAL study. J Antimicrob Chemother. 2013;68:409-13.
- Saumoy M, Sánchez-Quesada JL, Martínez E, et al. LDL subclasses and lipoprotein-phospholipase A2 activity in suppressed HIV-infected patients switching to raltegravir: Spiral substudy. Atherosclerosis. 2012;225:200-7.
Official Title A Randomized, Double Blind Study of the Safety and Efficacy of Dolutegravir (GSK1349572) 50mg Once Daily to Raltegravir 400mg Twice Daily Both Administered With Fixed-dose Dual Nucleoside Reverse Transcriptase Inhibitor Therapy Over 96 Weeks in HIV-1 Infected Antiretroviral Therapy Naive Adult Subjects
Phase Phase III
ClinicalTrials.gov NCT01227824
Treatments
Abacavir-Lamivudine
, Abacavir-Lamivudine
Tradename:EpzicomOther Names:ABC-3TCClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Dolutegravir
, Dolutegravir
Tradename:TivicayOther Names:DTGClass:Integrase Inhibitors (INSTI)Raltegravir
Raltegravir
Tradename:IsentressOther Names:RALClass:Integrase Inhibitors (INSTI)Categories Treatment-Naive
Funding
IndustryViiV Healthcare
References
- Raffi F, Jaeger H, Quiros-Roldan E, et al. Once-daily dolutegravir versus twice-daily raltegravir in antiretroviral-naive adults with HIV-1 infection (SPRING-2 study): 96 week results from a randomised, double-blind, non-inferiority trial. Lancet Infect Dis. 2013;13:927-35.
- Raffi F, Rachlis A, Brinson C, et al. Dolutegravir efficacy at 48 weeks in key subgroups of treatment-naive HIV-infected individuals in three randomized trials. AIDS. 2015;29:167-74.
- Raffi F, Rachlis A, Stellbrink HJ, et al. Once-daily dolutegravir versus raltegravir in antiretroviral-naive adults with HIV-1 infection: 48 week results from the randomised, double-blind, non-inferiority SPRING-2 study. Lancet. 2013;381:735-43.
Official Title A Multicenter, Double-Blind, Randomized, Active-Controlled Study to Evaluate the Safety and Antiretroviral Activity of Raltegravir (MK-0518) Versus Efavirenz in Treatment Naive HIV-Infected Patients, Each in Combination With TRUVADA™
Phase Phase III
ClinicalTrials.gov NCT00369941
Treatments
Raltegravir
, Raltegravir
Tradename:IsentressOther Names:RALClass:Integrase Inhibitors (INSTI)Efavirenz-Tenofovir DF-Emtricitabine
Efavirenz-Tenofovir DF-Emtricitabine
Tradename:AtriplaOther Names:EFV-TDF-FTC, Efavirenz-Tenofovir disoproxil fumarate-EmtricitabineClass:Single-Tablet RegimensCategories Treatment-Naive
Funding
IndustryMerck Sharp & Dohme Corp
References
- DeJesus E, Rockstroh JK, Lennox JL, et al. Efficacy of raltegravir versus efavirenz when combined with tenofovir/emtricitabine in treatment-naïve HIV-1-infected patients: week-192 overall and subgroup analyses from STARTMRK. HIV Clin Trials. 2012;13:228-32.
- Lennox JL, Dejesus E, Berger DS, et al. Raltegravir versus Efavirenz regimens in treatment-naive HIV-1-infected patients: 96-week efficacy, durability, subgroup, safety, and metabolic analyses. J Acquir Immune Defic Syndr. 2010;55:39-48.
- Lennox JL, Dejesus E, Lazzarin A, et al. Safety and efficacy of raltegravir-based versus efavirenz-based combination therapy in treatment-naive patients with HIV-1 infection: a multicentre, double-blind randomised controlled trial. Lancet. 2009;374(9692):796-806.
- Rockstroh JK, DeJesus E, Lennox JL, et al. Durable efficacy and safety of raltegravir versus efavirenz when combined with tenofovir/emtricitabine in treatment-naive HIV-1-infected patients: final 5-year results from STARTMRK. J Acquir Immune Defic Syndr. 2013;63:77-85.
- Rockstroh JK, Lennox JL, Dejesus E, et al. Long-term treatment with raltegravir or efavirenz combined with tenofovir/emtricitabine for treatment-naive human immunodeficiency virus-1-infected patients: 156-week results from STARTMRK. Clin Infect Dis. 2011;53:807-16.
Official Title A Multicenter, Double-Blind, Randomized, Active-Controlled Study to Evaluate the Safety and Antiretroviral Activity of Raltegravir (MK0518) Versus KALETRA in HIV-Infected Patients Switched From a Stable KALETRA-Based Regimen - Study A and Study B
Phase Phase III
ClinicalTrials.gov NCT00443703
Treatments
Raltegravir
, Raltegravir
Tradename:IsentressOther Names:RALClass:Integrase Inhibitors (INSTI)Lopinavir-Ritonavir
Lopinavir-Ritonavir
Tradename:KaletraOther Names:LPV-RTVClass:Protease Inhibitors (PI)Categories Treatment-ExperiencedSwitch/Simplification
Funding
IndustryMerck Sharp & Dohme Corp
References
- Eron JJ, Young B, Cooper DA, et al. Switch to a raltegravir-based regimen versus continuation of a lopinavir-ritonavir based regimen in stable HIV-infected patients with suppressed viraemia (SWITCHMRK 1 and 2): two multicentre, double-blind, randomized controlled trials. Lancet 2010; 375:396-407.
Official Title Impact of Raltegravir (Isentress/MK-0518) - Containing Regimens on HIV-1 Infected CD4+ T-Cells During Acute and Early HIV-1 Infection: A Randomized, Controlled Study Comparing Standard Antiretroviral Therapy to Standard Therapy Plus Raltegravir
Phase Phase IV
ClinicalTrials.gov NCT00781287
Treatments
Raltegravir
Raltegravir
Tradename:IsentressOther Names:RALClass:Integrase Inhibitors (INSTI)Categories Treatment-NaiveAcute HIV
Funding
IndustryMerck Sharp & Dohme Corp
Non-IndustryUniversity of Washington
References
- Collier AC, Chun TW, Maenza J, et al. A Pilot Study of Raltegravir Plus Combination Antiretroviral Therapy in Early Human Immunodeficiency Virus Infection: Challenges and Lessons Learned. Biores Open Access. 2016;5:15-21.
Raltegravir Slide Deck
February 22, 2020
Clinical Trial Image Decks
ACTG 5244 - February 21, 2020
ACTG 5260s - May 24, 2017
ACTG 5262 - February 21, 2020
ARDENT - February 21, 2020
BENCHMRK 1 and 2 - February 21, 2020
CHEER - February 21, 2020
EASIER - February 21, 2020
GS-183-0145 - May 22, 2017
HARNESS - February 21, 2020
NEAT001-ANRS 143 - February 21, 2020
ONCEMRK - February 21, 2020
OPTIPRIM - February 21, 2020
PANNA (Raltegravir) - February 21, 2020
PROGRESS - February 21, 2020
QDMRK - February 21, 2020
RADAR - February 21, 2020
RAL-PEP - February 21, 2020
ROCnRAL - February 21, 2020
SAILING - February 21, 2020
SECOND-LINE - February 21, 2020
SELECT - February 21, 2020
SHIELD - February 21, 2020
SPIRAL - February 21, 2020
SPRING-2 - February 21, 2020
STARTMRK - December 28, 2022
SWITCHMRK 1 and 2 - February 21, 2020
UW PIC 330 - February 21, 2020