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 alafenamide-Emtricitabine Genvoya
Rilpivirine-Tenofovir alafenamide-Emtricitabine Odefsey
Rilpivirine-Tenofovir DF-Emtricitabine Complera
Enfuvirtide Fuzeon
Fostemsavir Rukobia
Ibalizumab Trogarzo
Dolutegravir Tivicay
Abacavir Ziagen
Abacavir-Lamivudine-Zidovudine Trizivir
Didanosine Videx
Emtricitabine Emtriva
Lamivudine Epivir
Stavudine Zerit
Tenofovir alafenamide-Emtricitabine Descovy
Tenofovir DF Viread
Tenofovir DF-Emtricitabine Truvada and Multiple Generics
Zidovudine Retrovir
Zidovudine-Lamivudine Combivir
Doravirine Pifeltro
Efavirenz Sustiva
Etravirine Intelence
Nevirapine Viramune
Rilpivirine Edurant
Darunavir-Cobicistat Prezcobix
Fosamprenavir Lexiva
Indinavir Crixivan
Nelfinavir Viracept
Tipranavir AptivusAll Clinical Trials
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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 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.
Common TitleAI424-009 Industry
Official Title Safety and Antiviral Efficacy of a Novel HIV-1 Protease Inhibitor, Atazanavir (BMS-232632), in Combination Regimen(s) as Compared to a Reference Combination Regimen(s) in Antiretroviral-Experienced HIV-Infected Subjects
Phase Phase II
ClinicalTrials.gov NCT00004584
Treatments
Atazanavir
, Atazanavir
Tradename:ReyatazOther Names:ATVClass:Protease Inhibitors (PI)Saquinavir
Saquinavir
Tradename:InviraseOther Names:SQVClass:Protease Inhibitors (PI)Categories Resistance/Virological FailurePharmacologyTreatment-ExperiencedAdverse Effects
Funding
IndustryBristol-Myers Squibb
References
- Haas DW, Zala C, Schrader S, et al. Therapy with atazanavir plus saquinavir in patients failing highly active antiretroviral therapy: a randomized comparative pilot trial. AIDS. 2003;17:1339-49.
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.
Common TitleARIES Industry
Official Title Induction/Simplification With Atazanavir + Ritonavir + Abacavir/Lamivudine Fixed-Dose Combination In HIV-1 Infection
Phase Phase III
ClinicalTrials.gov NCT00440947
Treatments
Atazanavir
Atazanavir
Tradename:ReyatazOther Names:ATVClass:Protease Inhibitors (PI)Categories Treatment-ExperiencedSwitch/Simplification
Funding
IndustryViiV Healthcare
References
- Squires KE, Young B, DeJesus E, et al. ARIES 144 week results: durable virologic suppression in HIV-infected patients simplified to unboosted atazanavir/abacavir/lamivudine. HIV Clin Trials. 2012;13:233-44.
- Squires KE, Young B, DeJesus E, et al. Safety and efficacy of a 36-week induction regimen of abacavir/lamivudine and ritonavir-boosted atazanavir in HIV-infected patients. HIV Clin Trials. 2010;11:69-79.
- Squires KE, Young B, Dejesus E, et al. Similar efficacy and tolerability of atazanavir compared with atazanavir/ritonavir, each with abacavir/lamivudine after initial suppression with abacavir/lamivudine plus ritonavir-boosted atazanavir in HIV-infected patients. AIDS. 2010;24:2019-27.
Common TitleASSURE Industry
Official Title A Prospective, Randomized, Multicenter, Open-Label Study to Compare the Efficacy and Safety of Simplifying From a Regimen of Atazanavir (ATV) + Ritonavir (RTV) + Tenofovir/Emtricitabine to ATV + Abacavir/Lamivudine Without RTV in Virologically Suppressed, HIV-1 Infected, HLA-B*5701 Negative Subjects
Phase Phase IV
ClinicalTrials.gov NCT01102972
Treatments
Abacavir-Lamivudine
, Abacavir-Lamivudine
Tradename:EpzicomOther Names:ABC-3TCClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Atazanavir
Atazanavir
Tradename:ReyatazOther Names:ATVClass:Protease Inhibitors (PI)Categories PharmacologyTreatment-ExperiencedSwitch/SimplificationAdverse Effects
Funding
IndustryViiV Healthcare
References
- Wohl DA, Bhatti L, Small CB, et al. Simplification to abacavir/lamivudine + atazanavir maintains viral suppression and improves bone and renal biomarkers in ASSURE, a randomized, open label, non-inferiority trial. PLoS One. 2014;9:e96187.
- Wohl DA, Bhatti L, Small CB, et al. The ASSURE study: HIV-1 suppression is maintained with bone and renal biomarker improvement 48 weeks after ritonavir discontinuation and randomized switch to abacavir/lamivudine + atazanavir. HIV Med. 2016;17:106-17.
Official Title Pilot Study for the Evaluation of the Safety and the Feasibility of Treatment Simplification to Atazanavir/Ritonavir + Lamivudine in Patients Stably Treated With Two NRTIs + Atazanavir/Ritonavir With Optimal Virologic Response.
Phase Phase IV
ClinicalTrials.gov NCT00885482
Treatments
Atazanavir
Atazanavir
Tradename:ReyatazOther Names:ATVClass:Protease Inhibitors (PI)Categories Treatment-ExperiencedSwitch/SimplificationDual Therapy
Funding
Non-IndustryCatholic University of the Sacred Heart
References
- Di Giambenedetto S, Fabbiani M, Colafigli M, et al. Safety and feasibility of treatment simplification to atazanavir/ritonavir + lamivudine in HIV-infected patients on stable treatment with two nucleos(t)ide reverse transcriptase inhibitors + atazanavir/ritonavir with virological suppression (Atazanavir and Lamivudine for treatment Simplification, AtLaS pilot study). J Antimicrob Chemother. 2013;68:1364-72.
- Fabbiani M, Di Giambenedetto S, Quiros-Roldan E, et al. Simplification to atazanavir/ritonavir+lamivudine in virologically suppressed HIV-infected patients: 24-weeks interim analysis from ATLAS-M trial. J Int AIDS Soc. 2014;17:19808.
- Lombardi F, Belmonti S, Fabbiani M, et al. Impact of 48 weeks of atazanavir/ritonavir plus lamivudine dual therapy on cellular HIV-DNA levels in the AtLaS pilot study. J Antimicrob Chemother. 2016;71:3621-3622.
- Mondi A, Fabbiani M, Ciccarelli N, et al. Efficacy and safety of treatment simplification to atazanavir/ritonavir + lamivudine in HIV-infected patients with virological suppression: 144 week follow-up of the AtLaS pilot study. J Antimicrob Chemother. 2015;70:1843-9.
Common TitleBASIC Industry
Official Title A Randomised, Controlled, Open-Label, 48-Week, Study To Asses Differences in Changes In Plasma Lipid Profile Between Patients On Saquinavir/Ritonavir Or Atazanavir/Ritonavir In Combination With Tenofovir Disoproxil Fumarate And Emtricitabine As A First-line Regimen
Phase Phase IV
ClinicalTrials.gov NCT00389402
Treatments
Atazanavir
, Atazanavir
Tradename:ReyatazOther Names:ATVClass:Protease Inhibitors (PI)Saquinavir
Saquinavir
Tradename:InviraseOther Names:SQVClass:Protease Inhibitors (PI)Categories PharmacologyTreatment-NaiveAdverse Effects
Funding
IndustryHoffmann-La Roche
References
- Vrouenraets SM, Wit FW, Fernandez Garcia E, et al. Randomized comparison of metabolic and renal effects of saquinavir/r or atazanavir/r plus tenofovir/emtricitabine in treatment-naïve HIV-1-infected patients. HIV Med. 2011;12:620-31.
Common TitleBATON Industry
Official Title Boosted Atazanavir and Truvada Given Once-Daily (BATON Study): A Phase 4 Study of Safety, Efficacy & Adherence in HIV Infected, Antiretroviral Naïve Subjects Treated With a Simple Once-Daily Regimen
Phase Phase IV
ClinicalTrials.gov NCT00224445
Treatments
Atazanavir
Atazanavir
Tradename:ReyatazOther Names:ATVClass:Protease Inhibitors (PI)Categories PharmacologyTreatment-NaiveAdverse EffectsGeneral Pharmacology
Funding
IndustryGilead Sciences
References
- Elion R, Cohen C, Ward D, et al. Evaluation of efficacy, safety, pharmacokinetics, and adherence in HIV-1-infected, antiretroviral-naïve patients treated with ritonavir-boosted atazanavir plus fixed-dose tenofovir DF/emtricitabine given once daily. HIV Clin Trials. 2008;9:213-24.
Official Title A 96 Week Study Comparing the Antiviral Efficacy and Safety of Atazanavir/Ritonavir With Lopinavir/Ritonavir, Each in Combination With Fixed Dose Tenofovir-Emtricitabine in HIV-1 Infected Treatment in Naive Subjects
Phase Phase III
ClinicalTrials.gov NCT00272779
Treatments
Atazanavir
, Atazanavir
Tradename:ReyatazOther Names:ATVClass:Protease Inhibitors (PI)Lopinavir-Ritonavir
, Lopinavir-Ritonavir
Tradename:KaletraOther Names:LPV-RTVClass:Protease Inhibitors (PI)Ritonavir
Ritonavir
Tradename:NorvirOther Names:RTVClass:Pharmacokinetic EnhancersCategories Resistance/Virological FailureTreatment-NaivePharmacologyAdverse EffectsPregnancy/WomenGeneral Pharmacology
Funding
IndustryBristol-Myers Squibb
References
- Lataillade M, Chiarella J, Yang R, et al. Prevalence and clinical significance of HIV drug resistance mutations by ultra-deep sequencing in antiretroviral-naïve subjects in the CASTLE study. PLoS One. 2010;5:e10952.
- Malan N, Su J, Mancini M, et al. Gastrointestinal tolerability and quality of life in antiretroviral-naive HIV-1-infected patients: data from the CASTLE study. AIDS Care. 2010;22:677-86.
- McDonald C, Uy J, Hu W, et al. Clinical significance of hyperbilirubinemia among HIV-1-infected patients treated with atazanavir/ritonavir through 96 weeks in the CASTLE study. AIDS Patient Care STDS. 2012;26:259-64.
- Molina JM, Andrade-Villanueva J, Echevarria J, et al. Once-daily atazanavir/ritonavir compared with twice-daily lopinavir/ritonavir, each in combination with tenofovir and emtricitabine, for management of antiretroviral-naive HIV-1-infected patients: 96-week efficacy and safety results of the CASTLE study. J Acquir Immune Defic Syndr. 2010;53:323-32.
- Molina JM, Andrade-Villanueva J, Echevarria J, et al. Once-daily atazanavir/ritonavir versus twice-daily lopinavir/ritonavir, each in combination with tenofovir and emtricitabine, for management of antiretroviral-naive HIV-1-infected patients: 48 week efficacy and safety results of the CASTLE study. Lancet. 2008;372(9639):646-55.
- Moyle G, Hardy H, Uy J, et al. Changes in biomarkers in HIV-1-infected treatment-naive patients treated with tenofovir DF/emtricitabine plus atazanavir/ritonavir or lopinavir/ritonavir for 96 weeks: the CASTLE biomarker substudy. Antivir Ther. 2014;19:693-9.
- Moyle GJ, Hardy H, Farajallah A, DeGrosky M, McGrath D. Comparison of body composition changes between atazanavir/ritonavir and lopinavir/ritonavir each in combination with tenofovir/emtricitabine in antiretroviral-naïve patients with HIV-1 infection. Clin Drug Investig. 2014;34:287-96.
- Moyle GJ, Hardy H, Farajallah A, McGrath SJ, Kaplita S, Ward D. Changes in bone mineral density after 96 weeks of treatment with atazanavir/ritonavir or lopinavir/ritonavir plus tenofovir DF/emtricitabine in treatment-naive patients with HIV-1 infection: the CASTLE body composition substudy. J Acquir Immune Defic Syndr. 2015;68:40-5.
- Squires KE, Johnson M, Yang R, et al. Comparative gender analysis of the efficacy and safety of atazanavir/ritonavir and lopinavir/ritonavir at 96 weeks in the CASTLE study. J Antimicrob Chemother. 2011;66:363-70.
- Zhu L, Liao S, Child M, et al. Pharmacokinetics and inhibitory quotient of atazanavir/ritonavir versus lopinavir/ritonavir in HIV-infected, treatment-naive patients who participated in the CASTLE Study. J Antimicrob Chemother. 2012;67:465-8.
Official Title Comparison of 2 Alternative Antiretroviral Combinations in HIV Post-exposure Prophylaxis: AZT-3TC (Combivir®) + Lopinavir-ritonavir (Kaletra®) Versus AZT-3TC (Combivir®)+ Atazanavir (Reyataz®). Multicentre, Prospective, Randomized, Open Study
Phase Phase IV
ClinicalTrials.gov NCT00385645
Treatments
Atazanavir
, Atazanavir
Tradename:ReyatazOther Names:ATVClass:Protease Inhibitors (PI)Lopinavir-Ritonavir
Lopinavir-Ritonavir
Tradename:KaletraOther Names:LPV-RTVClass:Protease Inhibitors (PI)Categories PEP
Funding
Non-IndustryHospital Clinic of Barcelona
References
- Diaz-Brito V, León A, Knobel H, et al. Post-exposure prophylaxis for HIV infection: a clinical trial comparing lopinavir/ritonavir versus atazanavir each with zidovudine/lamivudine. Antivir Ther. 2012;17:337-46.
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 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, 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 Efficacy of Atazanavir / Ritonavir Monotherapy as Maintenance in Patients With Viral Suppression. Randomized, Open Label Non Inferiority Trial. A Phase 3 Study.
Phase Phase III
ClinicalTrials.gov NCT01511809
Treatments
Atazanavir
Atazanavir
Tradename:ReyatazOther Names:ATVClass:Protease Inhibitors (PI)Categories Treatment-ExperiencedSwitch/SimplificationMonotherapyPharmacologyAdverse Effects
Funding
Non-IndustryOspedale San Raffaele
References
- Castagna A, Spagnuolo V, Galli L, et al. Simplification to atazanavir/ritonavir monotherapy for HIV-1 treated individuals on virological suppression: 48-week efficacy and safety results. AIDS. 2014;28:2269-79.
- Galli L, Spagnuolo V, Bigoloni A, et al. Atazanavir/ritonavir monotherapy: 96 week efficacy, safety and bone mineral density from the MODAt randomized trial. J Antimicrob Chemother. 2016;71:1637-42.
Common TitlePRINCE-1 Industry
Official Title A Prospective Single Arm, Open-label, International, Multicenter Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Atazanavir (ATV) Powder Boosted With Ritonavir (RTV) With an Optimized NRTI Background Therapy, in HIV Infected Pediatric Patients Greater Than or Equal to 3 Months to Less Than 6 Years. (Pediatric Atazanavir International Clinical Evaluation: the PRINCE I Study)
Phase Phase III
ClinicalTrials.gov NCT01099579
Treatments
Atazanavir
Atazanavir
Tradename:ReyatazOther Names:ATVClass:Protease Inhibitors (PI)Categories PediatricsTreatment-NaiveTreatment-Experienced
Funding
IndustryBristol-Myers Squibb
References
- Strehlau R, Donati AP, Arce PM, et al. PRINCE-1: safety and efficacy of atazanavir powder and ritonavir liquid in HIV-1-infected antiretroviral-naïve and -experienced infants and children aged ≥3 months to <6 years. J Int AIDS Soc. 2015;18:19467.
Common TitlePRINCE-2 Industry
Official Title A Prospective Single Arm, Open-label, International, Multicenter Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Atazanavir (ATV) Powder Boosted With Ritonavir (RTV) With an Optimized NRTI Background Therapy, in Human Immunodeficiency Virus (HIV) Infected, Antiretroviral, Naive and Experienced Pediatric Subjects From 3 Months to Less Than 11 Years.(Pediatric Atazanavir International Clinical Evaluation: the PRINCE II Study)
Phase Phase III
ClinicalTrials.gov NCT01335698
Treatments
Atazanavir
Atazanavir
Tradename:ReyatazOther Names:ATVClass:Protease Inhibitors (PI)Funding
IndustryBristol-Myers Squibb
References
No references available for this clinical trial
Official Title Efficacy of Simplification to Atazanavir/Ritonavir + Lamivudine as Maintenance Therapy in Patients With Viral Suppression. Randomized, Open-label 96 Weeks Non-inferiority Trial
Phase Phase IV
ClinicalTrials.gov NCT01307488
Treatments
Atazanavir
Atazanavir
Tradename:ReyatazOther Names:ATVClass:Protease Inhibitors (PI)Categories Treatment-ExperiencedSwitch/SimplificationDual Therapy
Funding
IndustryBristol Myers-Squibb and Fundación SEIMC-GESIDA
References
- Perez-Molina JA, Rubio R, Rivero A, et al. Dual treatment with atazanavir-ritonavir plus lamivudine versus triple treatment with atazanavir-ritonavir plus two nucleos(t)ides in virologically stable patients with HIV-1 (SALT): 48 week results from a randomised, open-label, non-inferiority trial. Lancet Infect Dis. 2015;15:775-84.
- Perez-Molina JA, Rubio R, Rivero A, et al. Simplification to dual therapy (atazanavir/ritonavir + lamivudine) versus standard triple therapy [atazanavir/ritonavir + two nucleos(t)ides] in virologically stable patients on antiretroviral therapy: 96 week results from an open-label, non-inferiority, randomized clinical trial (SALT study). J Antimicrob Chemother. 2017;72:246-253.
Official Title An Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of a Fixed-Dose Combination of Abacavir 600 mg/Lamivudine 300 mg Once-Daily in Combination With Atazanavir 300 mg + Ritonavir 100 mg Once-Daily in Antiretroviral-Naïve HIV-1 Infected Subjects With Continuing Evaluation of Abacavir/Lamivudine Plus Atazanavir 400 mg for Maintenance Over an Additional 48 Weeks
Phase Phase IV
ClinicalTrials.gov NCT00426296
Treatments
Atazanavir
Atazanavir
Tradename:ReyatazOther Names:ATVClass:Protease Inhibitors (PI)Categories Treatment-Naive
Funding
IndustryGlaxoSmithKline
References
- Elion R, Dejesus E, Sension M, et al. Once-daily abacavir/lamivudine and ritonavir-boosted atazanavir for the treatment of HIV-1 infection in antiretroviral-naïve patients: a 48-week pilot study. HIV Clin Trials. 2008;9:152-63.
Official Title A Randomized Open-label Study of the Antiviral Efficacy and Safety of Atazanavir Versus Lopinavir/Ritonavir(LPV/RTV), Each in Combination With Two Nucleosides in Subjects Who Have Experienced Virologic Failure With Prior Protease Inhibitor-Containing HAART Regimen(s)
Phase Phase III
ClinicalTrials.gov NCT00028301
Treatments
Atazanavir
, Atazanavir
Tradename:ReyatazOther Names:ATVClass:Protease Inhibitors (PI)Lopinavir-Ritonavir
Lopinavir-Ritonavir
Tradename:KaletraOther Names:LPV-RTVClass:Protease Inhibitors (PI)Categories Resistance/Virological FailureTreatment-Experienced
Funding
IndustryBristol-Myers Squibb
References
- Cohen C, Nieto-Cisneros L, Zala C, et al. Comparison of atazanavir with lopinavir/ritonavir in patients with prior protease inhibitor failure: a randomized multinational trial. Curr Med Res Opin. 2005;21:1683-92.
Official Title Phase III Open Label Atazanavir (BMS-232632) in Combination With Ritonavir or Saquinavir, and Lopinavir/Ritonavir, Each With Tenofovir and a Nucleoside in Subjects With HIV
Phase Phase III
ClinicalTrials.gov NCT00035932
Treatments
Atazanavir
, Atazanavir
Tradename:ReyatazOther Names:ATVClass:Protease Inhibitors (PI)Lopinavir-Ritonavir
Lopinavir-Ritonavir
Tradename:KaletraOther Names:LPV-RTVClass:Protease Inhibitors (PI)Categories Resistance/Virological FailureTreatment-ExperiencedPharmacologyAdverse Effects
Funding
IndustryBristol-Myers Squibb
References
- Johnson M, Grinsztejn B, Rodriguez C, et al. 96-week comparison of once-daily atazanavir/ritonavir and twice-daily lopinavir/ritonavir in patients with multiple virologic failures. AIDS. 2006;20:711-8.
- Johnson M, Grinsztejn B, Rodriguez C, et al. Atazanavir plus ritonavir or saquinavir, and lopinavir/ritonavir in patients experiencing multiple virological failures. AIDS. 2005;19:685-94.
Common TitleStudy 089 Industry
Official Title Phase IV Study of Boosted Atazanavir (ATV) Versus Non-boosted ATV in Naive Patients
Phase Phase IV
ClinicalTrials.gov NCT00084253
Treatments
Atazanavir
Atazanavir
Tradename:ReyatazOther Names:ATVClass:Protease Inhibitors (PI)Categories Treatment-Naive
Funding
IndustryBristol-Myers Squibb
References
- Malan DR, Krantz E, David N, et al. 96-week efficacy and safety of atazanavir, with and without ritonavir, in a HAART regimen in treatment-naive patients. J Int Assoc Physicians AIDS Care (Chic). 2010;9:34-42.
- Malan DR, Krantz E, David N, Wirtz V, Hammond J, McGrath D. Efficacy and safety of atazanavir, with or without ritonavir, as part of once-daily highly active antiretroviral therapy regimens in antiretroviral-naive patients. J Acquir Immune Defic Syndr. 2008;47:161-7.
Official Title A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Elvitegravir/Emtricitabine/Tenofovir Disoproxil Fumarate/Cobicistat (GS-9350) Versus Ritonavir-Boosted Atazanavir Plus Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults
Phase Phase III
ClinicalTrials.gov NCT01106586
Treatments
Atazanavir
, Atazanavir
Tradename:ReyatazOther Names:ATVClass:Protease Inhibitors (PI)Elvitegravir-Cobicistat-Tenofovir DF-Emtricitabine
Elvitegravir-Cobicistat-Tenofovir DF-Emtricitabine
Tradename:StribildOther Names:EVG-COBI-TDF-FTCClass:Single-Tablet RegimensCategories Treatment-NaiveResistance/Virological Failure
Funding
IndustryGilead Sciences
References
- DeJesus E, Rockstroh JK, Henry K, et al. Co-formulated elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate versus ritonavir-boosted atazanavir plus co-formulated emtricitabine and tenofovir disoproxil fumarate for initial treatment of HIV-1 infection: a randomised, double-blind, phase 3, non-inferiority trial. Lancet. 2012;379:2429-38.
- Kulkarni R, Abram ME, McColl DJ, et al. Week 144 resistance analysis of elvitegravir/cobicistat/emtricitabine/tenofovir DF versus atazanavir+ritonavir+emtricitabine/tenofovir DF in antiretroviral-naïve patients. HIV Clin Trials. 2014;15:218-30.
- Rockstroh JK, DeJesus E, Henry K, et al. A randomized, double-blind comparison of coformulated elvitegravir/cobicistat/emtricitabine/tenofovir DF vs ritonavir-boosted atazanavir plus coformulated emtricitabine and tenofovir DF for initial treatment of HIV-1 infection: analysis of week 96 results. J Acquir Immune Defic Syndr. 2013;62:483-6.
Official Title A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Cobicistat (GS-9350)-boosted Atazanavir Versus Ritonavir-boosted Atazanavir Each Administered With Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults
Phase Phase III
ClinicalTrials.gov NCT01108510
Treatments
Atazanavir
, Atazanavir
Tradename:ReyatazOther Names:ATVClass:Protease Inhibitors (PI)Atazanavir-Cobicistat
, Atazanavir-Cobicistat
Tradename:EvotazOther Names:ATV-COBIClass:Protease Inhibitors (PI)Cobicistat
Cobicistat
Tradename:TybostOther Names:COBIClass:Pharmacokinetic EnhancersCategories Treatment-Naive
Funding
IndustryGilead Sciences
References
- Gallant JE, Koenig E, Andrade-Villanueva J, et al. Cobicistat versus ritonavir as a pharmacoenhancer of atazanavir plus emtricitabine/tenofovir disoproxil fumarate in treatment-naive HIV type 1-infected patients: week 48 results. J Infect Dis. 2013;208:32-9.
- Gallant JE, Koenig E, Andrade-Villanueva JF, et al. Brief Report: Cobicistat Compared With Ritonavir as a Pharmacoenhancer for Atazanavir in Combination With Emtricitabine/Tenofovir Disoproxil Fumarate: Week 144 Results. J Acquir Immune Defic Syndr. 2015;69:338-40.
Official Title A Randomized, Double-blind Phase 3B Study to Evaluate the Safety and Efficacy of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate Versus Ritonavir-Boosted Atazanavir Plus Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naïve Women
Phase Phase IIIB
ClinicalTrials.gov NCT01705574
Treatments
Atazanavir
, Atazanavir
Tradename:ReyatazOther Names:ATVClass:Protease Inhibitors (PI)Elvitegravir-Cobicistat-Tenofovir DF-Emtricitabine
Elvitegravir-Cobicistat-Tenofovir DF-Emtricitabine
Tradename:StribildOther Names:EVG-COBI-TDF-FTCClass:Single-Tablet RegimensCategories Pregnancy/WomenTreatment-Naive
Funding
IndustryGilead Sciences
References
- Squires K, Kityo C, Hodder S, et al. Integrase inhibitor versus protease inhibitor based regimen for HIV-1 infected women (WAVES): a randomised, controlled, double-blind, phase 3 study. Lancet HIV. 2016;3:e410-20.