Bictegravir-Tenofovir alafenamide-Emtricitabine Biktarvy
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Efavirenz-Tenofovir DF-Emtricitabine Atripla
Elvitegravir-Cobicistat-Tenofovir alafenamide-Emtricitabine Genvoya
Elvitegravir-Cobicistat-Tenofovir DF-Emtricitabine Stribild
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Tenofovir DF Viread
Tenofovir DF-Emtricitabine Truvada and Multiple Generics
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Nevirapine Viramune
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Atazanavir-Cobicistat Evotaz
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Common TitleACTG 364 Non-Industry
Official Title Comparison of the Virologic Efficacy of Nelfinavir and/or Efavirenz, EFV (DMP 266) in Combination With One or Two New Nucleoside Analogs in Nucleoside Experienced Subjects: A Roll-Over Study to ACTG 302/303
Phase Phase II
ClinicalTrials.gov NCT00001087
Treatments
Nelfinavir
Nelfinavir
Tradename:ViraceptOther Names:NFVClass:Protease Inhibitors (PI)Categories Treatment-ExperiencedResistance/Virological Failure
Funding
Non-IndustryNational Institute of Allergy and Infectious Diseases (NIAID)
References
- Albrecht MA, Bosch RJ, Hammer SM, et al. Nelfinavir, efavirenz, or both after the failure of nucleoside treatment of HIV infection. N Engl J Med. 2001;345:398-407.
- Katzenstein DA, Bosch RJ, Hellmann N, Wang N, Bacheler L, Albrecht MA. Phenotypic susceptibility and virological outcome in nucleoside-experienced patients receiving three or four antiretroviral drugs. AIDS. 2003;17:821-30.
Common TitleACTG 384 Non-Industry
Official Title Study of Protease Inhibitor and/or Non-Nucleoside Reverse Transcriptase Inhibitor With Dual Nucleosides in Initial Therapy of HIV Infection
Phase Phase III
ClinicalTrials.gov NCT00000919
Treatments
Stavudine
, Stavudine
Tradename:ZeritOther Names:d4TClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Zidovudine
, Zidovudine
Tradename:RetrovirOther Names:ZDVClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Nelfinavir
, Nelfinavir
Tradename:ViraceptOther Names:NFVClass:Protease Inhibitors (PI)Efavirenz
, Efavirenz
Tradename:SustivaOther Names:EFVClass:Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)Zidovudine-Lamivudine
Zidovudine-Lamivudine
Tradename:CombivirOther Names:ZDV-3TCClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Categories PharmacologyTreatment-NaiveAdverse EffectsDrug InteractionsGeneral Pharmacology
Funding
Non-IndustryNational Institute of Allergy and Infectious Diseases (NIAID)
References
- Dubé MP, Komarow L, Mulligan K, et al. Long-term body fat outcomes in antiretroviral-naive participants randomized to nelfinavir or efavirenz or both plus dual nucleosides. Dual X-ray absorptiometry results from A5005s, a substudy of Adult Clinical Trials Group 384. J Acquir Immune Defic Syndr. 2007;45:508-14.
- Dubé MP, Parker RA, Tebas P, et al. Glucose metabolism, lipid, and body fat changes in antiretroviral-naive subjects randomized to nelfinavir or efavirenz plus dual nucleosides. AIDS. 2005;19:1807-18.
- Gandhi RT, Spritzler J, Chan E, et al. Effect of baseline- and treatment-related factors on immunologic recovery after initiation of antiretroviral therapy in HIV-1-positive subjects: results from ACTG 384. J Acquir Immune Defic Syndr. 2006;42:426-34.
- Robbins GK, De Gruttola V, Shafer RW, et al. Comparison of sequential three-drug regimens as initial therapy for HIV-1 infection. N Engl J Med. 2003;349:2293-303.
- Shafer RW, Smeaton LM, Robbins GK, et al. Comparison of four-drug regimens and pairs of sequential three-drug regimens as initial therapy for HIV-1 infection. N Engl J Med. 2003;349:2304-15.
- Smith PF, Robbins GK, Shafer RW, et al. Pharmacokinetics of nelfinavir and efavirenz in antiretroviral-naive, human immunodeficiency virus-infected subjects when administered alone or in combination with nucleoside analog reverse transcriptase inhibitors. Antimicrob Agents Chemother. 2005;49:3558-61.
Official Title A Phase III Randomized, Controlled Trial of Efavirenz (EFV) or Nelfinavir (NFV) in Combination With Fixed-Dose Combination Lamivudine/Zidovudine (3TC/ZDV) and Indinavir (IDV) in HIV-Infected Subjects With Less Than or Equal to 200 CD4 Cells/mm3 or Greater Than or Equal to 80,000 HIV RNA Copies/ml in Plasma
Phase Phase III
ClinicalTrials.gov NCT00000903
Treatments
Indinavir
, Indinavir
Tradename:CrixivanOther Names:IDVClass:Protease Inhibitors (PI)Nelfinavir
, Nelfinavir
Tradename:ViraceptOther Names:NFVClass:Protease Inhibitors (PI)Efavirenz
, Efavirenz
Tradename:SustivaOther Names:EFVClass:Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)Zidovudine-Lamivudine
Zidovudine-Lamivudine
Tradename:CombivirOther Names:ZDV-3TCClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Categories Resistance/Virological FailureTreatment-Experienced
Funding
Non-IndustryNational Institute of Allergy and Infectious Diseases (NIAID)
References
- Demeter LM, Ribaudo HJ, Erice A, et al. HIV-1 drug resistance in subjects with advanced HIV-1 infection in whom antiretroviral combination therapy is failing: a substudy of AIDS Clinical Trials Group Protocol 388. Clin Infect Dis. 2004;39:552-8.
- Fischl MA, Ribaudo HJ, Collier AC, et al. A randomized trial of 2 different 4-drug antiretroviral regimens versus a 3-drug regimen, in advanced human immunodeficiency virus disease. J Infect Dis. 2003;188:625-34.
Common TitleACTG 5108 Non-Industry
Official Title The Effect of Efavirenz and Nelfinavir on the Pharmacokinetics of Hydroxymethylglutaryl Coenzyme A Reductase Inhibitors
Phase Phase I
ClinicalTrials.gov NCT00017758
Treatments
Nelfinavir
Nelfinavir
Tradename:ViraceptOther Names:NFVClass:Protease Inhibitors (PI)Categories PharmacologyDrug Interactions
Funding
Non-IndustryNational Institute of Allergy and Infectious Diseases (NIAID)
References
- Aberg JA, Rosenkranz SL, Fichtenbaum CJ, Alston BL, Brobst SW, Segal Y, Gerber JG; ACTG A5108 team. Pharmacokinetic interaction between nelfinavir and pravastatin in HIV-seronegative volunteers: ACTG Study A5108. AIDS. 2006;20:725-9.
Common TitleCPCRA 042 Non-Industry
Official Title A Randomized Trial of the Efficacy and Safety of a Strategy of Starting With Nelfinavir Versus Ritonavir Added to Background Antiretroviral (AR) Nucleoside Therapy in HIV-Infected Individuals With CD4+ Cell Counts Less Than or Equal to 200/mm3
ClinicalTrials.gov NCT00000859
Treatments
Nelfinavir
, Nelfinavir
Tradename:ViraceptOther Names:NFVClass:Protease Inhibitors (PI)Ritonavir
Ritonavir
Tradename:NorvirOther Names:RTVClass:Pharmacokinetic EnhancersCategories Treatment-Experienced
Funding
Non-IndustryNational Institute of Allergy and Infectious Diseases (NIAID)
References
- Perez G, MacArthur RD, Walmsley S, Baxter JA, Mullin C, Neaton JD. A randomized clinical trial comparing nelfinavir and ritonavir in patients with advanced HIV disease (CPCRA 042/CTN 102). HIV Clin Trials. 2004;5:7-18.
Common TitleESS40002 Industry
Official Title A 96-Week, Randomized, Open-Label, Multicenter Trial to Evaluate the Safety and Tolerability of the Antiretroviral Activity of Stavudine (40 mg BID) Plus Lamivudine (150mg BID) Plus Nelfinavir (1250 mg BID) Versus Abacavir (300 mg BID) Plus Combivir (3TC 150mg/ZDV 300 mg BID) Versus Combivir (3TC 150 mg/ZDV 300 mg BID) Plus Nelfinavir (1250mg BID) in HIV-1 Infected Subjects
Phase Phase IV
ClinicalTrials.gov NCT00005106
Treatments
Nelfinavir
, Nelfinavir
Tradename:ViraceptOther Names:NFVClass:Protease Inhibitors (PI)Abacavir-Lamivudine-Zidovudine
Abacavir-Lamivudine-Zidovudine
Tradename:TrizivirOther Names:ABC-3TC-ZDVClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Categories PharmacologyTreatment-NaiveAdverse Effects
Funding
IndustryGlaxo Wellcome
References
- Kumar PN, Rodriguez-French A, Thompson MA, et al. A prospective, 96-week study of the impact of Trizivir, Combivir/nelfinavir, and lamivudine/stavudine/nelfinavir on lipids, metabolic parameters and efficacy in antiretroviral-naive patients: effect of sex and ethnicity. HIV Med. 2006;7:85-98.
Official Title A Randomized, Double-Blind, Phase III Study of Lopinavir (ABT-378)/Ritonavir Plus Stavudine and Lamivudine vs Nelfinavir Plus Stavudine and Lamivudine in Antiretroviral Naive HIV-Infected Subjects
Phase Phase III
ClinicalTrials.gov NCT00004583
Treatments
Stavudine
, Stavudine
Tradename:ZeritOther Names:d4TClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Lopinavir-Ritonavir
, Lopinavir-Ritonavir
Tradename:KaletraOther Names:LPV-RTVClass:Protease Inhibitors (PI)Nelfinavir
Nelfinavir
Tradename:ViraceptOther Names:NFVClass:Protease Inhibitors (PI)Categories Resistance/Virological FailureTreatment-NaivePharmacologyAdverse Effects
Funding
IndustryAbbott
References
- Kempf DJ, King MS, Bernstein B, et al. Incidence of resistance in a double-blind study comparing lopinavir/ritonavir plus stavudine and lamivudine to nelfinavir plus stavudine and lamivudine. J Infect Dis. 2004;189:51-60.
- King MS, Bernstein BM, Walmsley SL, et al. Baseline HIV-1 RNA level and CD4 cell count predict time to loss of virologic response to nelfinavir, but not lopinavir/ritonavir, in antiretroviral therapy-naive patients. J Infect Dis. 2004;190:280-4.
- Sherman KE, Shire NJ, Cernohous P, et al. Liver injury and changes in hepatitis C Virus (HCV) RNA load associated with protease inhibitor-based antiretroviral therapy for treatment-naive HCV-HIV-coinfected patients: lopinavir-ritonavir versus nelfinavir. Clin Infect Dis. 2005;41:1186-95.
- Walmsley S, Bernstein B, King M, et al. Lopinavir-ritonavir versus nelfinavir for the initial treatment of HIV infection. N Engl J Med. 2002;346:2039-46.
Common TitleNEAT Industry
Official Title A Phase III, Randomised, Multicenter, Parallel, Open-Label Study to Compare the Efficacy, Safety, and Tolerability of Fosamprenavir (GW433908) (1400 Mg Bid) and Nelfinavir (1250 Mg Bid) Over 48 Weeks in Antiretroviral Therapy Naive HIV-1 Infected Adults
Phase Phase III
ClinicalTrials.gov NCT00008554
Treatments
Fosamprenavir
, Fosamprenavir
Tradename:LexivaOther Names:FPVClass:Protease Inhibitors (PI)Nelfinavir
Nelfinavir
Tradename:ViraceptOther Names:NFVClass:Protease Inhibitors (PI)Categories Treatment-Naive
Funding
IndustryGlaxo Wellcome
References
- Rodriguez-French A, Boghossian J, Gray GE, et al. The NEAT study: a 48-week open-label study to compare the antiviral efficacy and safety of GW433908 versus nelfinavir in antiretroviral therapy-naive HIV-1-infected patients. J Acquir Immune Defic Syndr. 2004;35:22-32.
Common TitlePACTG 377 Non-Industry
Official Title A Phase II Rolling Arm Master Protocol (PRAM) of Novel Antiretroviral Therapy in Stable Experienced HIV-Infected Children. PRAM-2: A Phase I/II Randomized, Multicenter Protocol Comparing Four Antiretroviral Regimens Containing Combinations of Protease Inhibitors, NRTIs and an NNRTI
Phase Phase I
ClinicalTrials.gov NCT00001091
Treatments
Nelfinavir
Nelfinavir
Tradename:ViraceptOther Names:NFVClass:Protease Inhibitors (PI)Categories Resistance/Virological FailurePediatricsTreatment-Experienced
Funding
Non-IndustryNational Institute of Allergy and Infectious Diseases (NIAID)
References
- Eshleman SH, Krogstad P, Jackson JB, et al. Analysis of human immunodeficiency virus type 1 drug resistance in children receiving nucleoside analogue reverse-transcriptase inhibitors plus nevirapine, nelfinavir, or ritonavir (Pediatric AIDS Clinical Trials Group 377). J Infect Dis. 2001;183:1732-8.
- Krogstad P, Lee S, Johnson G, et al. Nucleoside-analogue reverse-transcriptase inhibitors plus nevirapine, nelfinavir, or ritonavir for pretreated children infected with human immunodeficiency virus type 1. Clin Infect Dis. 2002;34:991-1001.
Common TitlePACTG 403 Non-Industry
Official Title A Phase II Randomized, Multicenter Protocol Evaluating Two Antiretroviral Regimens Containing Combinations of Protease Inhibitors, NRTIs, and an NNRTI
Phase Phase II
ClinicalTrials.gov NCT00000924
Treatments
Nelfinavir
Nelfinavir
Tradename:ViraceptOther Names:NFVClass:Protease Inhibitors (PI)Categories Resistance/Virological FailurePediatricsTreatment-Experienced
Funding
Non-IndustryNational Institute of Allergy and Infectious Diseases (NIAID)
References
- King JR, Nachman S, Yogev R, et al. Efficacy, tolerability and pharmacokinetics of two nelfinavir-based regimens in human immunodeficiency virus-infected children and adolescents: pediatric AIDS clinical trials group protocol 403. Pediatr Infect Dis J. 2005;24:880-5.
Common TitlePACTG 1043 Non-Industry
Official Title Phase III Randomized Trial of the Safety and Efficacy of Three Neonatal Antiretroviral Regimens for Prevention of Intrapartum HIV-1 Transmission
Phase Phase III
ClinicalTrials.gov NCT00099359
Treatments
Nelfinavir
Nelfinavir
Tradename:ViraceptOther Names:NFVClass:Protease Inhibitors (PI)Categories PharmacologyPediatricsTreatment-NaiveGeneral Pharmacology
Funding
Non-IndustryEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
References
- Mirochnick M, Nielsen-Saines K, Pilotto JH, et al. Nelfinavir and Lamivudine pharmacokinetics during the first two weeks of life. Pediatr Infect Dis J. 2011;30:769-72.
- Nielsen-Saines K, Watts DH, Veloso VG, et al. Three postpartum antiretroviral regimens to prevent intrapartum HIV infection. N Engl J Med. 2012;366:2368-79.
Common TitleSOLO Industry
Official Title A Randomized, Open-Label, Two Arm Trial to Compare the Safety and Antiviral Efficacy of Fosamprenavir (GW433908)/Ritonavir QD to Nelfinavir BID When Used in Combination With Abacavir and Lamivudine for 48 Weeks in Antiretroviral Therapy Naive HIV-1 Infected Subjects
Phase Phase III
ClinicalTrials.gov NCT00009061
Treatments
Fosamprenavir
, Fosamprenavir
Tradename:LexivaOther Names:FPVClass:Protease Inhibitors (PI)Nelfinavir
, Nelfinavir
Tradename:ViraceptOther Names:NFVClass:Protease Inhibitors (PI)Ritonavir
Ritonavir
Tradename:NorvirOther Names:RTVClass:Pharmacokinetic EnhancersCategories Treatment-Naive
Funding
IndustryGlaxo Wellcome
References
- Gathe JC Jr, Ive P, Wood R, et al. SOLO: 48-week efficacy and safety comparison of once-daily fosamprenavir /ritonavir versus twice-daily nelfinavir in naive HIV-1-infected patients. AIDS. 2004;18:1529-37.
- Gathe JC Jr, Wood R, Sanne I, et al. Long-term (120-Week) antiviral efficacy and tolerability of fosamprenavir/ritonavir once daily in therapy-naive patients with HIV-1 infection: an uncontrolled, open-label, single-arm follow-on study. Clin Ther. 2006;28:745-54.
Clinical Trial Image Decks
ACTG 388 - February 25, 2020
M98-863 - July 5, 2017