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
Efavirenz-Tenofovir DF-Emtricitabine Atripla
Elvitegravir-Cobicistat-Tenofovir DF-Emtricitabine Stribild
Rilpivirine-Tenofovir alafenamide-Emtricitabine Odefsey
Rilpivirine-Tenofovir DF-Emtricitabine Complera
Enfuvirtide Fuzeon
Fostemsavir Rukobia
Ibalizumab Trogarzo
Abacavir Ziagen
Abacavir-Lamivudine Epzicom
Abacavir-Lamivudine-Zidovudine Trizivir
Didanosine Videx
Emtricitabine Emtriva
Stavudine Zerit
Tenofovir DF Viread
Tenofovir DF-Emtricitabine Truvada and Multiple Generics
Zidovudine Retrovir
Zidovudine-Lamivudine Combivir
Doravirine Pifeltro
Efavirenz Sustiva
Nevirapine Viramune
Rilpivirine Edurant
Atazanavir-Cobicistat Evotaz
Darunavir-Cobicistat Prezcobix
Fosamprenavir Lexiva
Indinavir Crixivan
Nelfinavir Viracept
Saquinavir Invirase
Cobicistat TybostAll Clinical Trials
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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 Phase II, Open Label Trial, to Evaluate Pharmacokinetics, Safety, Tolerability and Antiviral Activity of DRV in Combination With Low-Dose Ritonavir (DRV/Rtv) in Treatment-Experienced HIV-1 Infected Children From 3 Years to Below 6 Years of Age
Phase Phase II
ClinicalTrials.gov NCT00919854
Treatments
Darunavir
Darunavir
Tradename:PrezistaOther Names:DRVClass:Protease Inhibitors (PI)Categories Resistance/Virological FailurePediatricsTreatment-Experienced
Funding
IndustryTibotec Pharmaceuticals, Ireland
References
- Violari A, Bologna R, Kumarasamy N, et al. Safety and efficacy of darunavir/ritonavir in treatment-experienced pediatric patients: week 48 results of the ARIEL trial. Pediatr Infect Dis J. 2015;34:e132-7.
Official Title Phase III Randomized, Controlled, Open-label Trial to Investigate the Antiviral Activity, Tolerability and Safety of Darunavir/Ritonavir (TMC114/r) in Treatment- Naive HIV-1 Infected Patients.
Phase Phase III
ClinicalTrials.gov NCT00258557
Treatments
Darunavir
, Darunavir
Tradename:PrezistaOther Names:DRVClass:Protease Inhibitors (PI)Lopinavir-Ritonavir
Lopinavir-Ritonavir
Tradename:KaletraOther Names:LPV-RTVClass:Protease Inhibitors (PI)Categories Resistance/Virological FailureTreatment-Naive
Funding
IndustryTibotec Pharmaceuticals, Ireland
References
- Lathouwers E, De Meyer S, Dierynck I, et al. Virological characterization of patients failing darunavir/ritonavir or lopinavir/ritonavir treatment in the ARTEMIS study: 96-week analysis. Antivir Ther. 2011;16:99-108.
- Mills AM, Nelson M, Jayaweera D, et al. Once-daily darunavir/ritonavir vs. lopinavir/ritonavir in treatment-naive, HIV-1-infected patients: 96-week analysis. AIDS. 2009;23:1679-88.
- Orkin C, DeJesus E, Khanlou H, et al. Final 192-week efficacy and safety of once-daily darunavir/ritonavir compared with lopinavir/ritonavir in HIV-1-infected treatment-naïve patients in the ARTEMIS trial. HIV Med. 2013;14:49-59.
- Ortiz R, Dejesus E, Khanlou H, et al. Efficacy and safety of once-daily darunavir/ritonavir versus lopinavir/ritonavir in treatment-naive HIV-1-infected patients at week 48. AIDS. 2008;22:1389-97.
Official Title A Phase II, Open-label Trial, to Investigate Pharmacokinetics, Safety, Tolerability and Antiviral Activity of (Darunavir)TMC114/Ritonavir b.i.d in Treatment-Experienced HIV-1 Infected Children and Adolescents
Phase Phase II
ClinicalTrials.gov NCT00355524
Treatments
Darunavir
Darunavir
Tradename:PrezistaOther Names:DRVClass:Protease Inhibitors (PI)Categories PediatricsTreatment-Experienced
Funding
IndustryTibotec Pharmaceuticals, Ireland
References
- Blanche S, Bologna R, Cahn P, et al. Pharmacokinetics, safety and efficacy of darunavir/ritonavir in treatment-experienced children and adolescents. AIDS. 2009;23:2005-13.
Official Title A Phase II, Open-Label Trial, to Evaluate Pharmacokinetics, Safety, Tolerability and Antiviral Activity of Drv/Rtv Once Daily in Treatment-Naive HIV-1 Infected Adolescents Aged Between 12 and < 18 Years
Phase Phase II
ClinicalTrials.gov NCT00915655
Treatments
Darunavir
Darunavir
Tradename:PrezistaOther Names:DRVClass:Protease Inhibitors (PI)Categories PediatricsTreatment-Naive
Funding
IndustryTibotec Pharmaceuticals, Ireland
References
- Flynn P, Komar S, Blanche S, et al. Efficacy and safety of darunavir/ritonavir at 48 weeks in treatment-naïve, HIV-1-infected adolescents: results from a phase 2 open-label trial (DIONE). Pediatr Infect Dis J. 2014;33:940-5.
Official Title An Open Label Randomized Clinical Trial, to Evaluate the Treatment With Darunavir/Ritonavir + Lamivudine Once Daily Versus Continuing With Darunavir/Ritonavir Once Daily + Tenofovir/Emtricitabine or Abacavir/Lamivudine in HIV Infected Subject With Suppressed Plasma Viremia
Phase Phase IV
ClinicalTrials.gov NCT02159599
Treatments
Darunavir
, Darunavir
Tradename:PrezistaOther Names:DRVClass:Protease Inhibitors (PI)Lamivudine
Lamivudine
Tradename:EpivirOther Names:3TCClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Categories Treatment-ExperiencedSwitch/SimplificationDual Therapy
Funding
Non-IndustryFundacion SEIMC-GESIDA
References
- Pulido F, Ribera E, Lagarde M, et al. Dual Therapy With Darunavir and Ritonavir Plus Lamivudine vs Triple Therapy With Darunavir and Ritonavir Plus Tenofovir Disoproxil Fumarate and Emtricitabine or Abacavir and Lamivudine for Maintenance of Human Immunodeficiency Virus Type 1 Viral Suppression: Randomized, Open-Label, Noninferiority DUAL-GESIDA 8014-RIS-EST45 Trial. Clin Infect Dis. 2017;65:2112-8.
Official Title Efficacy and Safety of Switching to Dolutegravir With Boosted Darunavir in Virologically Suppressed Adults With HIV-1: A Randomized, Open-Label, Multicenter, Phase 3, Noninferiority Trial: The DUALIS Study
Phase Phase III
Treatments
Darunavir
, Darunavir
Tradename:PrezistaOther Names:DRVClass:Protease Inhibitors (PI)Dolutegravir
Dolutegravir
Tradename:TivicayOther Names:DTGClass:Integrase Inhibitors (INSTI)Categories Treatment-ExperiencedSwitch/SimplificationDual Therapy
Funding
IndustryJanssen Pharmaceuticals and ViiV Healthcare
Non-IndustryTechnical University Munich
References
- Spinner CD, Kümmerle T, Schneider J, et al. Efficacy and Safety of Switching to Dolutegravir With Boosted Darunavir in Virologically Suppressed Adults With HIV-1: A Randomized, Open-Label, Multicenter, Phase 3, Noninferiority Trial: The DUALIS Study. Open Forum Infect Dis. 2020;7(9):ofaa356.
Official Title A Phase III Study to Investigate the Efficacy, Tolerability and Safety of Etravirine (TMC-125) as Part of an Antiretroviral Regimen, Including Darunavir/Ritonavir (TMC114/RTV) and an Investigator-selected Optimized Background, in HIV-1 Infected Patients With Limited to no Treatment Options.
Phase Phase III
ClinicalTrials.gov NCT00254046
Treatments
Darunavir
, Darunavir
Tradename:PrezistaOther Names:DRVClass:Protease Inhibitors (PI)Etravirine
Etravirine
Tradename:IntelenceOther Names:ETRClass:Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)Categories Resistance/Virological FailureTreatment-ExperiencedAdverse Effects
Funding
IndustryTibotec Pharmaceuticals, Ireland
References
- Anderson D, DeMasi R, DeLaitsch L, Surles T, Coate B. Week 96 outcomes of patients with less treatment experience versus more treatment experience receiving etravirine in the DUET trials. Curr HIV Res. 2012;10:256-61.
- Clotet B, Clumeck N, Katlama C, Nijs S, Witek J. Safety of etravirine in HIV-1/hepatitis B and/or C virus co-infected patients: pooled 96 week results from the Phase III DUET trials. J Antimicrob Chemother. 2010;65:2450-4.
- Girard PM, Campbell TB, Grinsztejn B, et al. Pooled week 96 results of the phase III DUET-1 and DUET-2 trials of etravirine: further analysis of adverse events and laboratory abnormalities of special interest. HIV Med. 2012;13:427-35.
- Katlama C, Clotet B, Mills A, et al. Efficacy and safety of etravirine at week 96 in treatment-experienced HIV type-1-infected patients in the DUET-1 and DUET-2 trials. Antivir Ther. 2010;15:1045-52.
- Katlama C, Haubrich R, Lalezari J, et al. Efficacy and safety of etravirine in treatment-experienced, HIV-1 patients: pooled 48 week analysis of two randomized, controlled trials. AIDS. 2009;23:2289-300.
- Madruga JV, Cahn P, Grinsztejn B, et al. Efficacy and safety of TMC125 (etravirine) in treatment-experienced HIV-1-infected patients in DUET-1: 24-week results from a randomised, double-blind, placebo-controlled trial. Lancet. 2007;370:29-38.
- Peeters M, Vingerhoets J, Tambuyzer L, et al. Etravirine limits the emergence of darunavir and other protease inhibitor resistance-associated mutations in the DUET trials. AIDS. 2010;24:921-4.
- Tambuyzer L, Vingerhoets J, Azijn H, et al. Characterization of genotypic and phenotypic changes in HIV-1-infected patients with virologic failure on an etravirine-containing regimen in the DUET-1 and DUET-2 clinical studies. AIDS Res Hum Retroviruses. 2010;26:1197-205.
Official Title A Phase III Randomized, Double-blinded, Placebo-controlled Trial to Investigate the Efficacy, Tolerability and Safety of Etravirine (TMC125) as Part of an ART Regimen, Including Darunavir/Ritonavir (TMC114/RTV) and an Investigator-selected OBR, in HIV-1 Infected Patients With Limited Treatment to no Treatment Options.
Phase Phase III
ClinicalTrials.gov NCT00255099
Treatments
Darunavir
, Darunavir
Tradename:PrezistaOther Names:DRVClass:Protease Inhibitors (PI)Etravirine
Etravirine
Tradename:IntelenceOther Names:ETRClass:Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)Categories Resistance/Virological FailureTreatment-ExperiencedAdverse Effects
Funding
IndustryTibotec Pharmaceuticals, Ireland
References
- Anderson D, DeMasi R, DeLaitsch L, Surles T, Coate B. Week 96 outcomes of patients with less treatment experience versus more treatment experience receiving etravirine in the DUET trials. Curr HIV Res. 2012;10:256-61.
- Clotet B, Clumeck N, Katlama C, Nijs S, Witek J. Safety of etravirine in HIV-1/hepatitis B and/or C virus co-infected patients: pooled 96 week results from the Phase III DUET trials. J Antimicrob Chemother. 2010;65:2450-4.
- Girard PM, Campbell TB, Grinsztejn B, et al. Pooled week 96 results of the phase III DUET-1 and DUET-2 trials of etravirine: further analysis of adverse events and laboratory abnormalities of special interest. HIV Med. 2012;13:427-35.
- Katlama C, Clotet B, Mills A, et al. Efficacy and safety of etravirine at week 96 in treatment-experienced HIV type-1-infected patients in the DUET-1 and DUET-2 trials. Antivir Ther. 2010;15:1045-52.
- Katlama C, Haubrich R, Lalezari J, et al. Efficacy and safety of etravirine in treatment-experienced, HIV-1 patients: pooled 48 week analysis of two randomized, controlled trials. AIDS. 2009;23:2289-300.
- Lazzarin A, Campbell T, Clotet B, et al. Efficacy and safety of TMC125 (etravirine) in treatment-experienced HIV-1-infected patients in DUET-2: 24-week results from a randomised, double-blind, placebo-controlled trial. Lancet. 2007;370:39-48.
- Peeters M, Vingerhoets J, Tambuyzer L, et al. Etravirine limits the emergence of darunavir and other protease inhibitor resistance-associated mutations in the DUET trials. AIDS. 2010;24:921-4.
- Tambuyzer L, Vingerhoets J, Azijn H, et al. Characterization of genotypic and phenotypic changes in HIV-1-infected patients with virologic failure on an etravirine-containing regimen in the DUET-1 and DUET-2 clinical studies. AIDS Res Hum Retroviruses. 2010;26:1197-205.
Official Title A Phase IIIb, Randomized, Open-label Study of the Safety and Efficacy of Dolutegravir, DTG (GSK1349572) 50 mg Once Daily Compared to Darunavir/Ritonavir (DRV/r) 800 mg/100 mg Once Daily Each Administered With Fixed-dose Dual Nucleoside Reverse Transcriptase Inhibitor Therapy Over 96 Weeks in HIV-1 Infected Antiretroviral naïve Adult Subjects
Phase Phase IIIB
ClinicalTrials.gov NCT01449929
Treatments
Darunavir
, Darunavir
Tradename:PrezistaOther Names:DRVClass:Protease Inhibitors (PI)Dolutegravir
, Dolutegravir
Tradename:TivicayOther Names:DTGClass:Integrase Inhibitors (INSTI)Ritonavir
Ritonavir
Tradename:NorvirOther Names:RTVClass:Pharmacokinetic EnhancersCategories Treatment-Naive
Funding
IndustryViiV Healthcare and Shionogi & Co.
References
- Clotet B, Feinberg J, van Lunzen J, et al. Once-daily dolutegravir versus darunavir plus ritonavir in antiretroviral-naive adults with HIV-1 infection (FLAMINGO): 48 week results from the randomised open-label phase 3b study. Lancet. 2014;383:2222-31.
- Molina JM, Clotet B, van Lunzen J, et al. Once-daily dolutegravir is superior to once-daily darunavir/ritonavir in treatment-naïve HIV-1-positive individuals: 96 week results from FLAMINGO. J Int AIDS Soc. 2014;17:19490.
- Molina JM, Clotet B, van Lunzen J, et al. Once-daily dolutegravir versus darunavir plus ritonavir for treatment-naive adults with HIV-1 infection (FLAMINGO): 96 week results from a randomised, open-label, phase 3b study. Lancet HIV. 2015;2:e127-36.
Official Title A Phase IV, Prospective, Multicenter , Randomized Open Label, 48 Weeks Study to Evaluate the Antiretroviral Efficacy and Safety of Atazanavir or Darunavir, Each in Combination With a Fixed Dose of Tenofovir Emtricitabine in HIV-1-infected Treatment-naïve Subjects With CD4 counts Below 200 µL
Phase Phase IV
ClinicalTrials.gov NCT01928407
Treatments
Darunavir
, Darunavir
Tradename:PrezistaOther Names:DRVClass:Protease Inhibitors (PI)Atazanavir
Atazanavir
Tradename:ReyatazOther Names:ATVClass:Protease Inhibitors (PI)Categories Treatment-Naive
Funding
IndustryBristol-Myers Squibb
References
- Slama L, Landman R, Assoumou L, et al. Efficacy and safety of once-daily ritonavir-boosted atazanavir or darunavir in combination with a dual nucleos(t)ide analogue backbone in HIV-1-infected combined ART (cART)-naive patients with severe immunosuppression: a 48 week, non-comparative, randomized, multicentre trial (IMEA 040 DATA trial). J Antimicrob Chemother. 2016;71:2252-61.
Official Title A Multicenter, Single Arm, Open-Label Study of the Once Daily Combination of Etravirine and Darunavir/Ritonavir As Dual Therapy in Early Treatment-Experienced Patients
Phase Phase II
ClinicalTrials.gov NCT01199939
Treatments
Darunavir
, Darunavir
Tradename:PrezistaOther Names:DRVClass:Protease Inhibitors (PI)Etravirine
Etravirine
Tradename:IntelenceOther Names:ETRClass:Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)Categories Resistance/Virological FailureTreatment-NaiveTreatment-ExperiencedDual Therapy
Funding
IndustryJanssen
References
- Ruane PJ, Brinson C, Ramgopal M, et al. The Intelence aNd pRezista Once A Day Study (INROADS): a multicentre, single-arm, open-label study of etravirine and darunavir/ritonavir as dual therapy in HIV-1-infected early treatment-experienced subjects. HIV Med. 2015;16:288-96.
Official Title A Multicenter, Open-label, Randomized Study to Assess the Metabolics, Efficacy, and Safety of Once-daily Darunavir Versus Atazanavir in HIV-infected Treatment-naive Adult Patients
Phase Phase IV
ClinicalTrials.gov NCT00757783
Treatments
Darunavir
, Darunavir
Tradename:PrezistaOther Names:DRVClass:Protease Inhibitors (PI)Atazanavir
Atazanavir
Tradename:ReyatazOther Names:ATVClass:Protease Inhibitors (PI)Categories PharmacologyTreatment-NaiveAdverse Effects
Funding
IndustryJanssen
References
- Aberg JA, Tebas P, Overton ET, et al. Metabolic effects of darunavir/ritonavir versus atazanavir/ritonavir in treatment-naive, HIV type 1-infected subjects over 48 weeks. AIDS Res Hum Retroviruses. 2012;28:1184-95.
- Overton ET, Tebas P, Coate B, et al. Effects of once-daily darunavir/ritonavir versus atazanavir/ritonavir on insulin sensitivity in HIV-infected persons over 48 weeks: results of an exploratory substudy of METABOLIK, a phase 4, randomized trial. HIV Clin Trials. 2016;17:72-7.
Official Title A Randomised, Controlled, Open-Label Trial to Compare Brachial Artery Reactivity and Cardiovascular Risk of a Treatment Simplification by Darunavir/Ritonavir (DRV/r) 800/100 mg O.D. Versus a Triple Combination Therapy Containing DRV/r in HIV-1 Infected Subjects With Undetectable Plasma HIV-1 RNA on Their Current Treatments.
Phase Phase II
ClinicalTrials.gov NCT01391013
Treatments
Darunavir
Darunavir
Tradename:PrezistaOther Names:DRVClass:Protease Inhibitors (PI)Categories PharmacologyTreatment-ExperiencedAdverse EffectsMonotherapy
Funding
IndustryJanssen-Cilag
References
- Guaraldi G, Zona S, Cossarizza A, et al. Randomized trial to evaluate cardiometabolic and endothelial function in patients with plasma HIV-1 RNA suppression switching to darunavir/ritonavir with or without nucleoside analogues. HIV Clin Trials. 2013;14:140-8.
- Guaraldi G, Zona S, Cossarizza A, et al. Switching to darunavir/ritonavir monotherapy vs. triple-therapy on body fat redistribution and bone mass in HIV-infected adults: the Monarch randomized controlled trial. Int J STD AIDS. 2014;25:207-12.
Official Title A Randomised, Controlled, Open-label Trial to Compare the Efficacy, Safety and Tolerability of a Treatment Simplification by Darunavir/Ritonavir (DRV/r) 800/100 mg O.D. vs a Triple Combination Therapy With DRV/r in HIV-1 Infected Patients With Undetectable Plasma HIV-RNA on Their Current Treatments.
Phase Phase III
ClinicalTrials.gov NCT00458302
Treatments
Darunavir
Darunavir
Tradename:PrezistaOther Names:DRVClass:Protease Inhibitors (PI)Categories Treatment-ExperiencedSwitch/SimplificationMonotherapyResistance/Virological FailureAdverse Effects
Funding
IndustryJanssen
References
- Arribas J, Hill A, Xi N, van Delft Y, Moecklinghoff C. Interleukin-6 and C-reactive protein levels after 3 years of treatment with darunavir/ritonavir monotherapy or darunavir/ritonavir + two nucleoside reverse transcriptase inhibitors in the MONET trial. J Antimicrob Chemother. 2012;67:1804-6.
- Arribas J, Pulido F, Hill A, Delft Yv, Moecklinghoff C. Predictors of long-term HIV RNA suppression on darunavir/ritonavir monotherapy in the MONET trial. Int J STD AIDS. 2013;24:679-81.
- Arribas JR, Clumeck N, Nelson M, Hill A, van Delft Y, Moecklinghoff C. The MONET trial: week 144 analysis of the efficacy of darunavir/ritonavir (DRV/r) monotherapy versus DRV/r plus two nucleoside reverse transcriptase inhibitors, for patients with viral load < 50 HIV-1 RNA copies/mL at baseline. HIV Med. 2012;13:398-405.
- Arribas JR, Horban A, Gerstoft J, et al. The MONET trial: darunavir/ritonavir with or without nucleoside analogues, for patients with HIV RNA below 50 copies/ml. AIDS. 2010;24:223-30.
- Clumeck N, Rieger A, Banhegyi D, et al. 96 week results from the MONET trial: a randomized comparison of darunavir/ritonavir with versus without nucleoside analogues, for patients with HIV RNA <50 copies/mL at baseline. J Antimicrob Chemother. 2011;66:1878-85.
- Geretti AM, Arribas JR, Lathouwers E, et al. Dynamics of cellular HIV-1 DNA levels over 144 weeks of darunavir/ritonavir monotherapy versus triple therapy in the MONET trial. HIV Clin Trials. 2013;14:45-50.
- Pulido F, Arribas JR, Hill A, Van Delft Y, Moecklinghoff C. Analysis of drug resistance during HIV RNA viraemia in the MONET trial of darunavir/ritonavir monotherapy. Antivir Ther. 2011;16:59-65.
- Winston A, Moecklinghoff C, Hill A. Three-year evaluation of neuropsychiatric adverse events in the MONET trial of darunavir/ritonavir, with or without nucleoside analogues. Int J STD AIDS. 2012;23:225-6.
Official Title A Randomized Multicenter Study With Non-inferiority Hypothesis, Comparing the Availability to Maintain a Complete Viral Suppression by a Monotherapy of Darunavir/r to a NRTI Containing Regimen Including Darunavir/r, in HIV-1 Infected Patients With Previous Prolonged Complete Viral Suppression. ANRS 136 MONOI
Phase Phase III
ClinicalTrials.gov NCT00421551
Treatments
Darunavir
Darunavir
Tradename:PrezistaOther Names:DRVClass:Protease Inhibitors (PI)Categories Treatment-ExperiencedSwitch/SimplificationMonotherapyResistance/Virological FailureAdverse Effects
Funding
Non-IndustryFrench National Agency for Research on AIDS and Viral Hepatitis
References
- Katlama C, Valantin MA, Algarte-Genin M, et al. Efficacy of darunavir/ritonavir maintenance monotherapy in patients with HIV-1 viral suppression: a randomized open-label, noninferiority trial, MONOI-ANRS 136. AIDS. 2010;24:2365-74.
- Lambert-Niclot S, Flandre P, Valantin MA, et al. Factors associated with virological failure in HIV-1-infected patients receiving darunavir/ritonavir monotherapy. J Infect Dis. 2011;204:1211-6.
- Lambert-Niclot S, Flandre P, Valantin MA, et al. Resistant minority species are rarely observed in patients on darunavir/ritonavir monotherapy. J Antimicrob Chemother. 2012;67:1470-4.
- Lambert-Niclot S, Flandre P, Valantin MA, et al. Similar evolution of cellular HIV-1 DNA level in darunavir/ritonavir monotherapy versus triple therapy in MONOI-ANRS136 trial over 96 weeks. PLoS One. 2012;7:e41390.
- Valantin MA, Kolta S, Flandre P, et al. Body fat distribution in HIV-infected patients treated for 96 weeks with darunavir/ritonavir monotherapy versus darunavir/ritonavir plus nucleoside reverse transcriptase inhibitors: the MONOI-ANRS136 substudy. HIV Med. 2012;13:505-15.
- Valantin MA, Lambert-Niclot S, Flandre P, et al. Long-term efficacy of darunavir/ritonavir monotherapy in patients with HIV-1 viral suppression: week 96 results from the MONOI ANRS 136 study. J Antimicrob Chemother. 2012;67:691-5.
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 Randomized, Open-label Trial to Compare the Efficacy, Safety and Tolerability of DRV/Rtv (800mg/100mg) q.d Versus DRV/Rtv (600mg/100mg) b.i.d in Early Treatment-experienced HIV-1 Infected Subjects
Phase Phase III
ClinicalTrials.gov NCT00524368
Treatments
Darunavir
Darunavir
Tradename:PrezistaOther Names:DRVClass:Protease Inhibitors (PI)Categories Resistance/Virological FailureTreatment-ExperiencedSwitch/Simplification
Funding
IndustryTibotec Pharmaceuticals, Ireland
References
- Arastéh K, Yeni P, Pozniak A, et al. Efficacy and safety of darunavir/ritonavir in treatment-experienced HIV type-1 patients in the POWER 1, 2 and 3 trials at week 96. Antivir Ther. 2009;14:859-64.
- Geretti AM, Moeketsi M, Demasi R, van Delft Y, Mohammed P. Efficacy of Once Daily Darunavir/Ritonavir in PI-Naïve, NNRTI-Experienced Patients in the ODIN Trial. AIDS Res Treat. 2015;2015:962574.
- Lathouwers E, De La Rosa G, Van de Casteele T, et al. Virological analysis of once-daily and twice-daily darunavir/ritonavir in the ODIN trial of treatment-experienced patients. Antivir Ther. 2013;18:289-300.
- Sension M, Cahn P, Domingo P, et al. Subgroup analysis of virological response rates with once- and twice-daily darunavir/ritonavir in treatment-experienced patients without darunavir resistance-associated mutations in the ODIN trial. HIV Med. 2013;14:437-44.
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
Darunavir
Darunavir
Tradename:PrezistaOther Names:DRVClass:Protease Inhibitors (PI)Categories PharmacologyPregnancy/WomenGeneral Pharmacology
Funding
Non-IndustryRadboud University
References
- Colbers A, Moltó J, Ivanovic J, et al. Pharmacokinetics of total and unbound darunavir in HIV-1-infected pregnant women. J Antimicrob Chemother. 2015;70:534-42.
Official Title A Prospective, Randomized, Open-labelled, Multi-centre Trial Comparing the Safety and Efficacy of Ritonavir-boosted Aptivus (Tipranavir, TPV/r) to That of Prezista® (Darunavir, DRV/r) in Three-class (NRTI, NNRTI, and PI) Treatment-experienced Patients With Resistance to More Than One PI. POTENT: PrOspecTive EvaluatioN of Tipranavir vs. Darunavir in Treatment Experienced Patients
Phase Phase III
ClinicalTrials.gov NCT00517192
Treatments
Darunavir
, Darunavir
Tradename:PrezistaOther Names:DRVClass:Protease Inhibitors (PI)Tipranavir
Tipranavir
Tradename:AptivusOther Names:TPVClass:Protease Inhibitors (PI)Categories Resistance/Virological FailureTreatment-Experienced
Funding
IndustryBoehringer Ingelheim
References
- Elgadi MM, Piliero PJ. Boosted tipranavir versus darunavir in treatment-experienced patients: observational data from the randomized POTENT trial. Drugs R D. 2011;11:295-302.
Official Title A Phase II Randomized, Controlled, Partially Blinded Trial to Investigate Dose Response of Darunavir/Ritonavir (TMC114/RTV) in 3-class-experienced HIV-1 Infected Patients, Followed by an Open-label Period on the Recommended Dose of Darunavir/Ritonavir (TMC114/RTV).
Phase Phase II
ClinicalTrials.gov NCT00071097
Treatments
Darunavir
Darunavir
Tradename:PrezistaOther Names:DRVClass:Protease Inhibitors (PI)Categories Resistance/Virological FailureTreatment-Experienced
Funding
IndustryTibotec Pharmaceuticals, Ireland
References
- Arastéh K, Yeni P, Pozniak A, et al. Efficacy and safety of darunavir/ritonavir in treatment-experienced HIV type-1 patients in the POWER 1, 2 and 3 trials at week 96. Antivir Ther. 2009;14:859-64.
- Clotet B, Bellos N, Molina JM, et al. Efficacy and safety of darunavir-ritonavir at week 48 in treatment-experienced patients with HIV-1 infection in POWER 1 and 2: a pooled subgroup analysis of data from two randomised trials. Lancet. 2007;369:1169-78.
- de Meyer S, Vangeneugden T, van Baelen B, et al. Resistance profile of darunavir: combined 24-week results from the POWER trials. AIDS Res Hum Retroviruses. 2008;24:379-88.
- De Meyer SM, Spinosa-Guzman S, Vangeneugden TJ, de Béthune MP, Miralles GD. Efficacy of once-daily darunavir/ritonavir 800/100 mg in HIV-infected, treatment-experienced patients with no baseline resistance-associated mutations to darunavir. J Acquir Immune Defic Syndr. 2008;49:179-82.
- Haubrich R, Berger D, Chiliade P, et al. Week 24 efficacy and safety of TMC114/ritonavir in treatment-experienced HIV patients. AIDS. 2007;21:F11-8.
- Hill A, Moyle G. Relative antiviral efficacy of ritonavir-boosted darunavir and ritonavir-boosted tipranavir vs. control protease inhibitor in the POWER and RESIST trials. HIV Med. 2007;8:259-64.
- Katlama C, Esposito R, Gatell JM, et al. Efficacy and safety of TMC114/ritonavir in treatment-experienced HIV patients: 24-week results of POWER 1. AIDS. 2007;21:395-402.
- Pozniak A, Opravil M, Beatty G, Hill A, de Béthune MP, Lefebvre E. Effect of baseline viral susceptibility on response to darunavir/ritonavir versus control protease inhibitors in treatment-experienced HIV type 1-infected patients: POWER 1 and 2. AIDS Res Hum Retroviruses. 2008;24:1275-80.
Official Title An Open Label Trial of Darunavir (TMC114)/RTV in HIV-1 Infected, Treatment-experienced Subjects.
Phase Phase II
ClinicalTrials.gov NCT00081588
Treatments
Darunavir
Darunavir
Tradename:PrezistaOther Names:DRVClass:Protease Inhibitors (PI)Categories Resistance/Virological FailureTreatment-Experienced
Funding
IndustryTibotec Pharmaceuticals, Ireland
References
- Arastéh K, Yeni P, Pozniak A, et al. Efficacy and safety of darunavir/ritonavir in treatment-experienced HIV type-1 patients in the POWER 1, 2 and 3 trials at week 96. Antivir Ther. 2009;14:859-64.
- de Meyer S, Vangeneugden T, van Baelen B, et al. Resistance profile of darunavir: combined 24-week results from the POWER trials. AIDS Res Hum Retroviruses. 2008;24:379-88.
- Molina JM, Cohen C, Katlama C, et al. Safety and efficacy of darunavir (TMC114) with low-dose ritonavir in treatment-experienced patients: 24-week results of POWER 3. J Acquir Immune Defic Syndr. 2007;46:24-31.
Official Title PROTEAse Inhibitor (DRV/Rtv) in Mono- or Triple Therapy in Suppressed HIV-1 Infected Subjects
Phase Phase III
ClinicalTrials.gov NCT01448707
Treatments
Darunavir
Darunavir
Tradename:PrezistaOther Names:DRVClass:Protease Inhibitors (PI)Categories Treatment-ExperiencedSwitch/SimplificationMonotherapy
Funding
IndustryJanssen
References
- Antinori A, Arribas J, Fehr J, et al. The PROTEA trial: darunavir/ritonavir with or without nucleoside analogues, for patients with HIV-1 RNA below 50 copies/mL. J Int AIDS Soc. 2014;17:19525.
- Antinori A, Clarke A, Svedhem-Johansson V, et al. Week 48 efficacy and central nervous system analysis of darunavir/ritonavir monotherapy versus darunavir/ritonavir with two nucleoside analogues. AIDS. 2015;29:1811-20.
- Girard PM, Antinori A, Arribas JR, et al. Week 96 efficacy and safety of darunavir/ritonavir monotherapy vs. darunavir/ritonavir with two nucleoside reverse transcriptase inhibitors in the PROTEA trial. HIV Med. 2017;18:5-12.
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 A Phase 3 Open-Label Study to Evaluate Switching From Optimized Stable Antiretroviral Regimens Containing Darunavir to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Single Tablet Regimen (STR) Plus Darunavir (DRV) in Treatment Experienced HIV-1 Positive Adults
Phase Phase III
ClinicalTrials.gov NCT01968551
Treatments
Darunavir
, Darunavir
Tradename:PrezistaOther Names:DRVClass:Protease Inhibitors (PI)Tenofovir alafenamide-Emtricitabine
, Tenofovir alafenamide-Emtricitabine
Tradename:DescovyOther Names:TAF-FTCClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Elvitegravir-Cobicistat-Tenofovir alafenamide-Emtricitabine
Elvitegravir-Cobicistat-Tenofovir alafenamide-Emtricitabine
Tradename:GenvoyaOther Names:EVG-COBI-TAF-FTCClass:Single-Tablet RegimensCategories Treatment-ExperiencedSwitch/Simplification
Funding
IndustryGilead Sciences
References
- Huhn GD, Tebas P, Gallant J, et al. A Randomized, Open-Label Trial to Evaluate Switching to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Plus Darunavir in Treatment-Experienced HIV-1-Infected Adults. J Acquir Immune Defic Syndr. 2017;74:193-200.
Official Title A Randomized, Controlled, Open-label Trial to Compare the Efficacy, Safety and Tolerability of Darunavir/Ritonavir (TMC114/RTV) Versus Lopinavir/Ritonavir in Treatment-Experienced HIV-1 Infected Patients
Phase Phase III
ClinicalTrials.gov NCT00110877
Treatments
Darunavir
, Darunavir
Tradename:PrezistaOther Names:DRVClass:Protease Inhibitors (PI)Lopinavir-Ritonavir
Lopinavir-Ritonavir
Tradename:KaletraOther Names:LPV-RTVClass:Protease Inhibitors (PI)Categories Resistance/Virological FailureTreatment-Experienced
Funding
IndustryTibotec Pharmaceuticals, Ireland
References
- Bánhegyi D, Katlama C, da Cunha CA, et al. Week 96 efficacy, virology and safety of darunavir/r versus lopinavir/r in treatment-experienced patients in TITAN. Curr HIV Res. 2012;10:171-81.
- De Meyer S, Lathouwers E, Dierynck I, et al. Characterization of virologic failure patients on darunavir/ritonavir in treatment-experienced patients. AIDS. 2009;23(14):1829-40.
- Madruga JV, Berger D, McMurchie M, et al. Efficacy and safety of darunavir-ritonavir compared with that of lopinavir-ritonavir at 48 weeks in treatment-experienced, HIV-infected patients in TITAN: a randomised controlled phase III trial. Lancet. 2007;370:49-58.
Official Title Prospective Clinical Trial to Assess Safety and Efficacy of Darunavir/ritonavir (TMC 114/r), Etravirine (TMC 125) and Raltegravir (MK-0518) in Addition to OBT in HIV-1 Infected Patients With Limited to No Treatment Options ANRS 139 TRIO
Phase Phase II
ClinicalTrials.gov NCT00460382
Treatments
Darunavir
, Darunavir
Tradename:PrezistaOther Names:DRVClass:Protease Inhibitors (PI)Etravirine
Etravirine
Tradename:IntelenceOther Names:ETRClass:Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)Categories Resistance/Virological FailureTreatment-Experienced
Funding
IndustryMerck Sharp & Dohme Corp; Janssen
Non-IndustryFrench National Agency for Research on AIDS and Viral Hepatitis
References
- Charpentier C, Fagard C, Colin C, et al. Role of baseline HIV-1 DNA level in highly-experienced patients receiving raltegravir, etravirine and darunavir/ritonavir regimen (ANRS139 TRIO trial). PLoS One. 2013;8:e53621.
- Charpentier C, Lee GQ, Rodriguez C, et al. Highly frequent HIV-1 minority resistant variants at baseline of the ANRS 139 TRIO trial had a limited impact on virological response. J Antimicrob Chemother. 2015;70:2090-6.
- Charpentier C, Roquebert B, Colin C, et al. Resistance analyses in highly experienced patients failing raltegravir, etravirine and darunavir/ritonavir regimen. AIDS. 2010;24:2651-6.
- Fagard C, Colin C, Charpentier C, et al. Long-term efficacy and safety of raltegravir, etravirine, and darunavir/ritonavir in treatment-experienced patients: week 96 results from the ANRS 139 TRIO trial. J Acquir Immune Defic Syndr. 2012;59:489-93.
- Yazdanpanah Y, Fagard C, Descamps D, et al. High rate of virologic suppression with raltegravir plus etravirine and darunavir/ritonavir among treatment-experienced patients infected with multidrug-resistant HIV: results of the ANRS 139 TRIO trial. Clin Infect Dis. 2009;49:1441-9.