Bictegravir-Tenofovir alafenamide-Emtricitabine Biktarvy
Darunavir-Cobicistat-Tenofovir alafenamide-Emtricitabine Symtuza
Dolutegravir-Abacavir-Lamivudine Triumeq
Dolutegravir-Lamivudine Dovato
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Doravirine-Tenofovir DF-Lamivudine Delstrigo
Efavirenz-Tenofovir DF-Emtricitabine Atripla
Elvitegravir-Cobicistat-Tenofovir alafenamide-Emtricitabine Genvoya
Elvitegravir-Cobicistat-Tenofovir DF-Emtricitabine Stribild
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Tenofovir alafenamide-Emtricitabine Descovy
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Tenofovir DF-Emtricitabine Truvada and Multiple Generics
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Common Title1286 Industry
Official Title A Multicenter, Randomized, Open-label, Controlled Study of Nevirapine (VIRAMUNE®) and a Short Course of Prednisone to Determine the Safety and Effectiveness of This Strategy in Preventing Nevirapine (VIRAMUNE®) Associated Rash.
Phase Phase IV
ClinicalTrials.gov NCT02184299
Treatments
Nevirapine
Nevirapine
Tradename:ViramuneOther Names:NVPClass:Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)Categories PharmacologyAdverse Effects
Funding
IndustryBoehringer Ingelheim
References
- Montaner JS, Cahn P, Zala C, et al. Randomized, controlled study of the effects of a short course of prednisone on the incidence of rash associated with nevirapine in patients infected with HIV-1. J Acquir Immune Defic Syndr. 2003;33:41-6.
Common Title2NN Industry
Phase Phase IV
ClinicalTrials.gov NCT00127972
Treatments
Nevirapine
Nevirapine
Tradename:ViramuneOther Names:NVPClass:Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)Categories Treatment-Naive
Funding
IndustryBoehringer Ingelheim
References
- van Leth F, Phanuphak P, Ruxrungtham K, et al. Comparison of first-line antiretroviral therapy with regimens including nevirapine, efavirenz, or both drugs, plus stavudine and lamivudine: a randomised open-label trial, the 2NN Study. Lancet. 2004;363(9417):1253-63.
Common TitleACTG 180 Non-Industry
Official Title Pharmacokinetics, Safety, Tolerance, and Activity of Nevirapine (BI-RG-587) Alone and in Combination With AZT in Mildly to Moderately Symptomatic HIV-1 Infected Children
Phase Phase II
ClinicalTrials.gov NCT00001111
Treatments
Nevirapine
Nevirapine
Tradename:ViramuneOther Names:NVPClass:Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)Categories PediatricsTreatment-Naive
Funding
Non-IndustryNational Institute of Allergy and Infectious Diseases (NIAID)
References
- Luzuriaga K, Bryson Y, Krogstad P, et al. Combination treatment with zidovudine, didanosine, and nevirapine in infants with human immunodeficiency virus type 1 infection. N Engl J Med. 1997;336:1343-9.
Common TitleACTG 241 Non-Industry
Official Title A Comparative Study of a Combination of Zidovudine, Didanosine, and Double-Blinded Nevirapine Versus a Combination of Zidovudine and Didanosine
Phase Phase II
ClinicalTrials.gov NCT00000770
Treatments
Nevirapine
Nevirapine
Tradename:ViramuneOther Names:NVPClass:Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)Categories PharmacologyTreatment-ExperiencedAdverse EffectsDual TherapyResistance/Virological FailureGeneral Pharmacology
Funding
Non-IndustryNational Institute of Allergy and Infectious Diseases (NIAID)
References
- D'Aquila RT, Hughes MD, Johnson VA, et al. Nevirapine, zidovudine, and didanosine compared with zidovudine and didanosine in patients with HIV-1 infection. A randomized, double-blind, placebo-controlled trial. National Institute of Allergy and Infectious Diseases AIDS Clinical Trials Group Protocol 241 Investigators. Ann Intern Med. 1996;124:1019-30.
- Hanna GJ, Johnson VA, Kuritzkes DR, et al. Patterns of resistance mutations selected by treatment of human immunodeficiency virus type 1 infection with zidovudine, didanosine, and nevirapine. J Infect Dis. 2000;181:904-11.
- Zhou XJ, Sheiner LB, D'Aquila RT, et al. Population pharmacokinetics of nevirapine, zidovudine, and didanosine in human immunodeficiency virus-infected patients. The National Institute of Allergy and Infectious Diseases AIDS Clinical Trials Group Protocol 241 Investigators. Antimicrob Agents Chemother. 1999;43:121-8.
Common TitleARTEN Industry
Official Title Randomized, Open Label Study Evaluating the Lipid Profile Difference and Efficacy of a Combined Therapy Including Tenofovir, Emtricitabine + Atazanavir / r or NVP in Naive HIV - 1 Infected Patients.
Phase Phase III
ClinicalTrials.gov NCT00389207
Treatments
Nevirapine
Nevirapine
Tradename:ViramuneOther Names:NVPClass:Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)Categories PharmacologyTreatment-NaiveAdverse EffectsResistance/Virological Failure
Funding
IndustryBoehringer Ingelheim
References
- Podzamczer D, Andrade-Villanueva J, Clotet B, et al. Lipid profiles for nevirapine vs. atazanavir/ritonavir, both combined with tenofovir disoproxil fumarate and emtricitabine over 48 weeks, in treatment-naïve HIV-1-infected patients (the ARTEN study). HIV Med. 2011;12:374-82.
- Soriano V, Arastéh K, Migrone H, et al. Nevirapine versus atazanavir/ritonavir, each combined with tenofovir disoproxil fumarate/emtricitabine, in antiretroviral-naive HIV-1 patients: the ARTEN Trial. Antivir Ther. 2011;16:339-48.
Common TitleATLANTIC Industry
Official Title A Randomized Open-Label Strategic Study to Evaluate the Safety and Efficacy of 3 Different Convergent and Divergent Drug Combination Therapies in Anti-Retroviral Naive HIV-1 Infected Patients With CD4+ Counts Above 200/mm3
ClinicalTrials.gov NCT00002407
Treatments
Stavudine
, Stavudine
Tradename:ZeritOther Names:d4TClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Indinavir
, Indinavir
Tradename:CrixivanOther Names:IDVClass:Protease Inhibitors (PI)Nevirapine
, Nevirapine
Tradename:ViramuneOther Names:NVPClass:Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)Didanosine
Didanosine
Tradename:VidexOther Names:ddIClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Categories PharmacologyTreatment-NaiveAdverse Effects
Funding
IndustryBristol-Myers Squibb and Boehringer Ingelheim
References
- van der Valk M, Kastelein JJ, Murphy RL, et al. Nevirapine-containing antiretroviral therapy in HIV-1 infected patients results in an anti-atherogenic lipid profile. AIDS. 2001;15:2407-14.
- van Leeuwen R, Katlama C, Murphy RL, et al. A randomized trial to study first-line combination therapy with or without a protease inhibitor in HIV-1-infected patients. AIDS. 2003;17:987-99.
Common TitleHIVNET 012 Non-Industry
Official Title A Phase III Placebo-Controlled Trial to Determine the Efficacy of Oral AZT and the Efficacy of Oral Nevirapine for the Prevention of Vertical Transmission of HIV-1 Infection in Pregnant Ugandan Women and Their Neonates
Phase Phase III
ClinicalTrials.gov NCT00006396
Treatments
Nevirapine
Nevirapine
Tradename:ViramuneOther Names:NVPClass:Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)Categories Resistance/Virological FailurePregnancy/WomenPediatrics
Funding
Non-IndustryNational Institute of Allergy and Infectious Diseases
References
- Eshleman SH, Mracna M, Guay LA, et al. Selection and fading of resistance mutations in women and infants receiving nevirapine to prevent HIV-1 vertical transmission (HIVNET 012). AIDS. 2001;15:1951-7.
- Guay LA, Musoke P, Fleming T, et al. Intrapartum and neonatal single-dose nevirapine compared with zidovudine for prevention of mother-to-child transmission of HIV-1 in Kampala, Uganda: HIVNET 012 randomised trial. Lancet. 1999;354:795-802.
- Jackson JB, Musoke P, Fleming T, et al. Intrapartum and neonatal single-dose nevirapine compared with zidovudine for prevention of mother-to-child transmission of HIV-1 in Kampala, Uganda: 18-month follow-up of the HIVNET 012 randomised trial. Lancet. 2003;362:859-68.
Common TitleMULTINEKA Non-Industry
Official Title Randomised, Prospective Multicentre Clinical Study on the Effect of the Combination of Lopinavir/Rtv + Nevirapine as Maintenance Bitherapy (Without Nucleoside Analogues) in Comparison With a Triple Therapy Including Lopinavir/Rtv + Nucleoside Analogues in HIV-Infected Patients
Phase Phase IV
ClinicalTrials.gov NCT00335686
Treatments
Nevirapine
Nevirapine
Tradename:ViramuneOther Names:NVPClass:Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)Categories Treatment-ExperiencedSwitch/SimplificationDual Therapy
Funding
Non-IndustryGermans Trias i Pujol Hospital
References
- Negredo E, Miró O, Rodríguez-Santiago B, et al. Improvement of mitochondrial toxicity in patients receiving a nucleoside reverse-transcriptase inhibitor-sparing strategy: results from the Multicenter Study with Nevirapine and Kaletra (MULTINEKA). Clin Infect Dis. 2009;49:892-900.
Common TitleNEWART Industry
Official Title Comparison Atazanavir/Ritonavir (ATV/r) vs Nevirapine (NVP) Twice a Day (Bid) on Truvada Backbone
Phase Phase IV
ClinicalTrials.gov NCT00552240
Treatments
Nevirapine
Nevirapine
Tradename:ViramuneOther Names:NVPClass:Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)Categories Treatment-Naive
Funding
IndustryBoehringer Ingelheim
References
- Dejesus E, Mills A, Bhatti L, Conner C, Storfer S. A randomised comparison of safety and efficacy of nevirapine vs. atazanavir/ritonavir combined with tenofovir/emtricitabine in treatment-naïve patients. Int J Clin Pract. 2011;65:1240-9.
Common TitleOCTANE A5208 Non-Industry
Official Title Optimal Combination Therapy After Nevirapine Exposure
Phase Phase III
ClinicalTrials.gov NCT00089505
Treatments
Nevirapine
Nevirapine
Tradename:ViramuneOther Names:NVPClass:Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)Categories Resistance/Virological FailurePregnancy/WomenPharmacologyAdverse EffectsTreatment-Experienced
Funding
Non-IndustryNational Institute of Allergy and Infectious Diseases (NIAID)
References
- Boltz VF, Bao Y, Lockman S, et al. Low-frequency nevirapine (NVP)-resistant HIV-1 variants are not associated with failure of antiretroviral therapy in women without prior exposure to single-dose NVP. J Infect Dis. 2014;209:703-10.
- Dong BJ, Zheng Y, Hughes MD, et al. Nevirapine pharmacokinetics and risk of rash and hepatitis among HIV-infected sub-Saharan African women. AIDS. 2012;26:833-41.
- Lockman S, Hughes M, Sawe F, et al. Nevirapine- versus lopinavir/ritonavir-based initial therapy for HIV-1 infection among women in Africa: a randomized trial. PLoS Med. 2012;9:e1001236.
- Lockman S, Hughes MD, McIntyre J, et al. Antiretroviral therapies in women after single-dose nevirapine exposure. N Engl J Med. 2010;363:1499-509.
- Mwafongo A, Nkanaunena K, Zheng Y, et al. Renal events among women treated with tenofovir/emtricitabine in combination with either lopinavir/ritonavir or nevirapine. AIDS. 2014;28:1135-42.
Common TitleP1060 Non-Industry
Official Title Phase II, Parallel, Randomized, Clinical Trials Comparing the Responses to Initiation of NNRTI-Based Versus PI-Based Antiretroviral Therapy in HIV Infected Infants Who Have and Have Not Previously Received Single Dose Nevirapine for Prevention of Mother-to-Child HIV Transmission
Phase Phase II
ClinicalTrials.gov NCT00307151
Treatments
Nevirapine
Nevirapine
Tradename:ViramuneOther Names:NVPClass:Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)Categories Resistance/Virological FailurePediatricsPregnancy/WomenTreatment-Experienced
Funding
Non-IndustryNational Institute of Allergy and Infectious Diseases (NIAID)
References
- Lindsey JC, Hughes MD, Violari A, et al. Predictors of virologic and clinical response to nevirapine versus lopinavir/ritonavir-based antiretroviral therapy in young children with and without prior nevirapine exposure for the prevention of mother-to-child HIV transmission. Pediatr Infect Dis J. 2014;33:846-54.
- Palumbo P, Lindsey JC, Hughes MD, et al. Antiretroviral treatment for children with peripartum nevirapine exposure. N Engl J Med. 2010;363:1510-20.
- Violari A, Lindsey JC, Hughes MD, et al. Nevirapine versus ritonavir-boosted lopinavir for HIV-infected children. N Engl J Med. 2012;366:2380-9.
Common TitlePACT 1022 Non-Industry
Official Title Randomized Trial of Protease Inhibitor-Including vs. Protease Inhibitor-Sparing Regimens for Women Who Initiate Therapy of HIV Infection During Pregnancy
Phase Phase III
ClinicalTrials.gov NCT00017719
Treatments
Nevirapine
Nevirapine
Tradename:ViramuneOther Names:NVPClass:Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)Categories PharmacologyPregnancy/WomenGeneral PharmacologyAdverse Effects
Funding
Non-IndustryNational Institute of Allergy and Infectious Diseases (NIAID)
References
- Capparelli EV, Aweeka F, Hitti J, et al. Chronic administration of nevirapine during pregnancy: impact of pregnancy on pharmacokinetics. HIV Med. 2008;9:214-20.
- Hitti J, Frenkel LM, Stek AM, et al. Maternal toxicity with continuous nevirapine in pregnancy: results from PACTG 1022. J Acquir Immune Defic Syndr. 2004;36:772-6.
Common TitlePACTG 316 Non-Industry
Official Title A Phase III Randomized, Blinded Study of Nevirapine for the Prevention of Maternal-Fetal Transmission in Pregnant HIV-Infected Women
Phase Phase III
ClinicalTrials.gov NCT00000869
Treatments
Nevirapine
Nevirapine
Tradename:ViramuneOther Names:NVPClass:Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)Categories Pregnancy/WomenResistance/Virological FailurePediatricsPharmacologyAdverse Effects
Funding
Non-IndustryNational Institute of Allergy and Infectious Diseases (NIAID)
References
- Cunningham CK, Balasubramanian R, Delke I, et al. The impact of race/ethnicity on mother-to-child HIV transmission in the United States in Pediatric AIDS Clinical Trials Group Protocol 316. J Acquir Immune Defic Syndr. 2004;36:800-7.
- Cunningham CK, Chaix ML, Rekacewicz C, et al. Development of resistance mutations in women receiving standard antiretroviral therapy who received intrapartum nevirapine to prevent perinatal human immunodeficiency virus type 1 transmission: a substudy of pediatric AIDS clinical trials group protocol 316. J Infect Dis. 2002;186:181-8.
- Dorenbaum A, Cunningham CK, Gelber RD, et al. Two-dose intrapartum/newborn nevirapine and standard antiretroviral therapy to reduce perinatal HIV transmission: a randomized trial. JAMA. 2003;288:189-98.
- Newell ML, Huang S, Fiore S, et al. Characteristics and management of HIV-1-infected pregnant women enrolled in a randomised trial: differences between Europe and the USA. BMC Infect Dis. 2007;7:60.
- Watts DH, Balasubramanian R, Maupin RT Jr, et al. Maternal toxicity and pregnancy complications in human immunodeficiency virus-infected women receiving antiretroviral therapy: PACTG 316. Am J Obstet Gynecol. 2004;190:506-16.
Common TitleSIROCCO Industry
Official Title Efavirenz to Nevirapine Switch in HIV-1 Infected Patients With Severe Dyslipidemia: A Randomized Controlled Study
Phase Phase IV
ClinicalTrials.gov NCT00405171
Treatments
Nevirapine
Nevirapine
Tradename:ViramuneOther Names:NVPClass:Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)Categories PharmacologyTreatment-ExperiencedSwitch/SimplificationAdverse Effects
Funding
IndustryBoehringer Ingelheim
References
- Parienti JJ, Massari V, Rey D, Poubeau P, Verdon R. Efavirenz to nevirapine switch in HIV-1-infected patients with dyslipidemia: a randomized, controlled study. Clin Infect Dis. 2007;45:263-6.
Common TitleTRANxITION Industry
Official Title An Open Label, Phase IIIb, Randomised Parallel Group Study to Assess the Efficacy and Safety of Switching HIV-1 Infected Patients Successfully Treated With a Nevirapine IR Based Regiment to Nevirapine XR 400 mg QD or Remaining on Nevirapine IR 200 mg BID Based Program
Phase Phase IIIB
ClinicalTrials.gov NCT00819052
Treatments
Nevirapine
Nevirapine
Tradename:ViramuneOther Names:NVPClass:Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)Categories Treatment-ExperiencedSwitch/Simplification
Funding
IndustryBoehringer Ingelheim
References
- Arasteh K, Ward D, Plettenberg A, et al. Twenty-four-week efficacy and safety of switching virologically suppressed HIV-1-infected patients from nevirapine immediate release 200 mg twice daily to nevirapine extended release 400 mg once daily (TRANxITION). HIV Med. 2012;13:236-44.
Common TitleVERxVE Industry
Official Title A Randomised, Double Blind, Double Dummy, Parallel Group, Active Controlled Trial to Evaluate the Antiviral Efficacy of 400 mg QD neVirapine Extended Release Formulation in Comparison to 200 mg BID neVirapinE Immediate Release in Combination With Truvada® in Antiretroviral Therapy naïve HIV-1 Infected Patients (VERxVE)
Phase Phase III
ClinicalTrials.gov NCT00561925
Treatments
Nevirapine
Nevirapine
Tradename:ViramuneOther Names:NVPClass:Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)Categories Treatment-Naive
Funding
IndustryBoehringer Ingelheim
References
- Gathe J, Andrade-Villanueva J, Santiago S, et al. Efficacy and safety of nevirapine extended-release once daily versus nevirapine immediate-release twice-daily in treatment-naive HIV-1-infected patients. Antivir Ther. 2011;16:759-69.