Bictegravir-Tenofovir alafenamide-Emtricitabine Biktarvy
Darunavir-Cobicistat-Tenofovir alafenamide-Emtricitabine Symtuza
Dolutegravir-Abacavir-Lamivudine Triumeq
Dolutegravir-Lamivudine Dovato
Dolutegravir-Rilpivirine Juluca
Doravirine-Tenofovir DF-Lamivudine Delstrigo
Elvitegravir-Cobicistat-Tenofovir alafenamide-Emtricitabine Genvoya
Elvitegravir-Cobicistat-Tenofovir DF-Emtricitabine Stribild
Rilpivirine-Tenofovir alafenamide-Emtricitabine Odefsey
Rilpivirine-Tenofovir DF-Emtricitabine Complera
Fostemsavir Rukobia
Ibalizumab Trogarzo
Doravirine Pifeltro
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Etravirine Intelence
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Official Title The ARDENT Study: Atazanavir, Raltegravir, or Darunavir With Emtricitabine/Tenofovir for Naive Treatment
Phase Phase III
ClinicalTrials.gov NCT00811954
Treatments
Raltegravir
Raltegravir
Tradename:IsentressOther Names:RALClass:Integrase Inhibitors (INSTI)Categories 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 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
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
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 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)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 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)Funding
Non-IndustryKirby Institute
References
No references available for this clinical trial
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
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)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.