Bictegravir-Tenofovir alafenamide-Emtricitabine Biktarvy
Darunavir-Cobicistat-Tenofovir alafenamide-Emtricitabine Symtuza
Dolutegravir-Abacavir-Lamivudine Triumeq
Dolutegravir-Lamivudine Dovato
Dolutegravir-Rilpivirine Juluca
Doravirine-Tenofovir DF-Lamivudine Delstrigo
Elvitegravir-Cobicistat-Tenofovir alafenamide-Emtricitabine Genvoya
Elvitegravir-Cobicistat-Tenofovir DF-Emtricitabine Stribild
Rilpivirine-Tenofovir alafenamide-Emtricitabine Odefsey
Rilpivirine-Tenofovir DF-Emtricitabine Complera
Enfuvirtide Fuzeon
Fostemsavir Rukobia
Ibalizumab Trogarzo
Maraviroc Selzentry
Dolutegravir Tivicay
Raltegravir Isentress
Abacavir Ziagen
Abacavir-Lamivudine Epzicom
Abacavir-Lamivudine-Zidovudine Trizivir
Didanosine Videx
Tenofovir alafenamide-Emtricitabine Descovy
Tenofovir DF-Emtricitabine Truvada and Multiple Generics
Doravirine Pifeltro
Etravirine Intelence
Nevirapine Viramune
Rilpivirine Edurant
Atazanavir Reyataz
Atazanavir-Cobicistat Evotaz
Darunavir Prezista
Darunavir-Cobicistat Prezcobix
Fosamprenavir Lexiva
Saquinavir Invirase
Tipranavir Aptivus
Cobicistat Tybost
Ritonavir NorvirAll Clinical Trials
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Common TitleACTG 002 Non-Industry
Official Title A Multi-Center Clinical Trial To Evaluate Azidothymidine (AZT) in the Treatment of Human Immunodeficiency Virus (HIV) Infection in Patients With AIDS Post First Episode PCP
Phase Phase III
ClinicalTrials.gov NCT00000700
Treatments
Zidovudine
Zidovudine
Tradename:RetrovirOther Names:ZDVClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Categories PharmacologyTreatment-NaiveAdverse EffectsMonotherapy
Funding
Non-IndustryNational Institute of Allergy and Infectious Diseases (NIAID)
References
- Fischl MA, Parker CB, Pettinelli C, et al. A randomized controlled trial of a reduced daily dose of zidovudine in patients with the acquired immunodeficiency syndrome. The AIDS Clinical Trials Group. N Engl J Med. 1990;323:1009-14.
Common TitleACTG 016 Non-Industry
Official Title The Safety and Efficacy of Zidovudine in the Treatment of Patients With Early AIDS Related Complex
Phase Phase III
ClinicalTrials.gov NCT00001011
Treatments
Zidovudine
Zidovudine
Tradename:RetrovirOther Names:ZDVClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Categories Treatment-NaiveMonotherapy
Funding
Non-IndustryNational Institute of Allergy and Infectious Diseases (NIAID)
References
- Fischl MA, Richman DD, Hansen N, et al. The safety and efficacy of zidovudine (AZT) in the treatment of subjects with mildly symptomatic human immunodeficiency virus type 1 (HIV) infection. A double-blind, placebo-controlled trial. The AIDS Clinical Trials Group. Ann Intern Med. 1990;112:727-37.
Common TitleACTG 019 Non-Industry
Official Title Safety and Efficacy of Zidovudine for Asymptomatic HIV-Infected Individuals
Phase Phase III
ClinicalTrials.gov NCT00000736
Treatments
Zidovudine
Zidovudine
Tradename:RetrovirOther Names:ZDVClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Categories Treatment-NaiveMonotherapy
Funding
Non-IndustryNational Institute of Allergy and Infectious Diseases (NIAID)
References
- Volberding PA, Lagakos SW, Grimes JM, et al. A comparison of immediate with deferred zidovudine therapy for asymptomatic HIV-infected adults with CD4 cell counts of 500 or more per cubic millimeter. AIDS Clinical Trials Group. N Engl J Med. 1995;333:401-7.
- Volberding PA, Lagakos SW, Koch MA, et al. Zidovudine in asymptomatic human immunodeficiency virus infection. A controlled trial in persons with fewer than 500 CD4-positive cells per cubic millimeter. The AIDS Clinical Trials Group of the National Institute of Allergy and Infectious Diseases. N Engl J Med. 1990;322:941-9.
Common TitleACTG 076 Non-Industry
Official Title A Phase III Randomized Placebo-Controlled Trial to Evaluate the Efficacy, Safety and Tolerance of Oral Zidovudine (AZT) in Pregnant HIV Infected Women and Their Infants
Phase Phase III
ClinicalTrials.gov NCT00000960
Treatments
Zidovudine
Zidovudine
Tradename:RetrovirOther Names:ZDVClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Categories PediatricsMonotherapyPregnancy/WomenAdverse EffectsPharmacology
Funding
Non-IndustryNational Institute of Allergy and Infectious Diseases (NIAID)
References
- Connor EM, Sperling RS, Gelber R, et al. Reduction of maternal-infant transmission of human immunodeficiency virus type 1 with zidovudine treatment. Pediatric AIDS Clinical Trials Group Protocol 076 Study Group. N Engl J Med. 1994;331:1173-80.
- Culnane M, Fowler M, Lee SS, et al. Lack of long-term effects of in utero exposure to zidovudine among uninfected children born to HIV-infected women. Pediatric AIDS Clinical Trials Group Protocol 219/076 Teams. JAMA. 1999;281:151-7.
- Frenkel LM, Cowles MK, Shapiro DE, et al. Analysis of the maternal components of the AIDS clinical trial group 076 zidovudine regimen in the prevention of mother-to-infant transmission of human immunodeficiency virus type 1. J Infect Dis. 1997;175:971-4.
- Sperling RS, Shapiro DE, Coombs RW, et al. Maternal viral load, zidovudine treatment, and the risk of transmission of human immunodeficiency virus type 1 from mother to infant. Pediatric AIDS Clinical Trials Group Protocol 076 Study Group. N Engl J Med. 1996;335:1621-9.
- Sperling RS, Shapiro DE, McSherry GD, et al. Safety of the maternal-infant zidovudine regimen utilized in the Pediatric AIDS Clinical Trial Group 076 Study. AIDS. 1998;12:1805-13.
Common TitleACTG 116 Non-Industry
Official Title A Randomized, Double Blind, Comparative Study of Dideoxycytidine (ddC) Alone or ddC/AZT Combination Versus Zidovudine (ZDV) Alone in Patients With HIV Infection Who Have Received Prior ZDV Therapy
Phase Phase III
ClinicalTrials.gov NCT00000651
Treatments
Zidovudine
Zidovudine
Tradename:RetrovirOther Names:ZDVClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Categories PharmacologyTreatment-ExperiencedAdverse EffectsMonotherapy
Funding
Non-IndustryNational Institute of Allergy and Infectious Diseases (NIAID)
References
- Fischl MA, Stanley K, Collier AC, et al. Combination and monotherapy with zidovudine and zalcitabine in patients with advanced HIV disease. The NIAID AIDS Clinical Trials Group. Ann Intern Med. 1995;122:24-32.
Common TitleACTG 185 Non-Industry
Official Title A Phase III Randomized, Double-Blind, Controlled Study of the Use of Anti-HIV Immune Serum Globulin (HIVIG) for the Prevention of Maternal-Fetal HIV Transmission in Pregnant Women and Newborns Receiving Zidovudine (AZT)
Phase Phase III
ClinicalTrials.gov NCT00000751
Treatments
Zidovudine
Zidovudine
Tradename:RetrovirOther Names:ZDVClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Categories PharmacologyPregnancy/WomenPediatricsMonotherapyGeneral PharmacologyAdverse Effects
Funding
Non-IndustryNational Institute of Allergy and Infectious Diseases (NIAID)
References
- Lambert JS, Mofenson LM, Fletcher CV, et al. Safety and pharmacokinetics of hyperimmune anti-human immunodeficiency virus (HIV) immunoglobulin administered to HIV-infected pregnant women and their newborns. Pediatric AIDS Clinical Trials Group Protocol 185 Pharmacokinetic Study Group. J Infect Dis. 1997;175:283-91.
- Lambert JS, Watts DH, Mofenson L, et al. Risk factors for preterm birth, low birth weight, and intrauterine growth retardation in infants born to HIV-infected pregnant women receiving zidovudine. Pediatric AIDS Clinical Trials Group 185 Team. AIDS. 2000;14:1389-99.
- Mofenson LM, Lambert JS, Stiehm ER, et al. Risk factors for perinatal transmission of human immunodeficiency virus type 1 in women treated with zidovudine. Pediatric AIDS Clinical Trials Group Study 185 Team. N Engl J Med. 1999;341:385-93.
- Stiehm ER, Lambert JS, Mofenson LM, et al. Efficacy of zidovudine and human immunodeficiency virus (HIV) hyperimmune immunoglobulin for reducing perinatal HIV transmission from HIV-infected women with advanced disease: results of Pediatric AIDS Clinical Trials Group protocol 185. J Infect Dis. 1999;179:567-75.
- Watts DH, Lambert J, Stiehm ER, et al. Progression of HIV disease among women following delivery. J Acquir Immune Defic Syndr. 2003;33:585-93.
Common TitleACTG 290 Non-Industry
Official Title A Phase II Randomized Study of the Virologic and Immunologic Effects of d4T vs Zidovudine Plus d4T vs Zidovudine Plus Ddl in HIV-Infected Patients With CD4 Cell Counts Between 300-600/mm3 and Greater Than 12 Weeks Zidovudine Experience
Phase Phase II
ClinicalTrials.gov NCT00001063
Treatments
Stavudine
, Stavudine
Tradename:ZeritOther Names:d4TClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Zidovudine
Zidovudine
Tradename:RetrovirOther Names:ZDVClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Categories Dual TherapyMonotherapy
Funding
Non-IndustryNational Institute of Allergy and Infectious Diseases (NIAID)
References
- Havlir DV, Tierney C, Friedland GH, et al. In vivo antagonism with zidovudine plus stavudine combination therapy. J Infect Dis. 2000;182:321-5.
Common TitleACTG 298 Non-Industry
Official Title A Phase II Randomized Study of the Virologic and Immunologic Effects of Zidovudine Plus Lamivudine (3TC) Versus d4T Versus Zidovudine Plus d4T in HIV-Infected Patients With CD4 Cell Counts Between 300-600/mm3 and No Previous Nucleoside Experience
Phase Phase II
ClinicalTrials.gov NCT00001067
Treatments
Stavudine
, Stavudine
Tradename:ZeritOther Names:d4TClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Zidovudine
, Zidovudine
Tradename:RetrovirOther Names:ZDVClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Zidovudine-Lamivudine
Zidovudine-Lamivudine
Tradename:CombivirOther Names:ZDV-3TCClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Categories Treatment-NaiveDual TherapyMonotherapy
Funding
Non-IndustryNational Institute of Allergy and Infectious Diseases (NIAID)
References
- Pollard RB, Tierney C, Havlir D, et al. A phase II randomized study of the virologic and immunologic effect of zidovudine + stavudine versus stavudine alone and zidovudine + lamivudine in patients with >300 CD4 cells who were antiretroviral naive (ACTG 298). AIDS Res Hum Retroviruses. 2002;18:699-704.
Common TitleACTG 320 Non-Industry
Official Title A Randomized, Double-Blind, Phase III Study of Indinavir Sulfate With Open-Label Zidovudine (AZT) and Lamivudine (3TC) in Subjects With HIV Infection With CD4 Cell Counts ≤ 200 Cells/mm3 and ≥ 6 Months of Prior AZT Experience
Phase Phase III
ClinicalTrials.gov NCT00000841
Treatments
Zidovudine
, Zidovudine
Tradename:RetrovirOther Names:ZDVClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Indinavir
, Indinavir
Tradename:CrixivanOther Names:IDVClass:Protease Inhibitors (PI)Zidovudine-Lamivudine
Zidovudine-Lamivudine
Tradename:CombivirOther Names:ZDV-3TCClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Categories Treatment-ExperiencedDual TherapyResistance/Virological Failure
Funding
Non-IndustryNational Institute of Allergy and Infectious Diseases (NIAID)
References
- Coplan PM, Cook JR, Carides GW, et al. Impact of indinavir on the quality of life in patients with advanced HIV infection treated with zidovudine and lamivudine. Clin Infect Dis. 2004;39:426-33.
- Demeter LM, Bosch RJ, Coombs RW, et al. Detection of replication-competent human immunodeficiency virus type 1 (HIV-1) in cultures from patients with levels of HIV-1 RNA in plasma suppressed to less than 500 or 50 copies per milliliter. J Clin Microbiol. 2002;40:2089-94.
- Demeter LM, Hughes MD, Coombs RW, et al. Predictors of virologic and clinical outcomes in HIV-1-infected patients receiving concurrent treatment with indinavir, zidovudine, and lamivudine. AIDS Clinical Trials Group Protocol 320. Ann Intern Med. 2001;135:954-64.
- Dykes C, Najjar J, Bosch RJ, et al. Detection of drug-resistant minority variants of HIV-1 during virologic failure of indinavir, lamivudine, and zidovudine. J Infect Dis. 2004;189:1091-6.
- Hammer SM, Squires KE, Hughes MD, et al. A controlled trial of two nucleoside analogues plus indinavir in persons with human immunodeficiency virus infection and CD4 cell counts of 200 per cubic millimeter or less. AIDS Clinical Trials Group 320 Study Team. N Engl J Med. 1997;337:725-33
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, Open-Label Comparison of Lopinavir/Ritonavir Plus Efavirenz Versus Lopinavir/Ritonavir Plus 2 NRTIs Versus Efavirenz Plus 2 NRTIs as Initial Therapy for HIV-1 Infection
Phase Phase III
ClinicalTrials.gov NCT00050895
Treatments
Stavudine
, Stavudine
Tradename:ZeritOther Names:d4TClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Zidovudine
, Zidovudine
Tradename:RetrovirOther Names:ZDVClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Lopinavir-Ritonavir
, Lopinavir-Ritonavir
Tradename:KaletraOther Names:LPV-RTVClass:Protease Inhibitors (PI)Efavirenz
, Efavirenz
Tradename:SustivaOther Names:EFVClass:Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)Tenofovir DF
Tenofovir DF
Tradename:VireadOther Names:TDF, tenofovir disoproxil fumarateClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Categories PharmacologyTreatment-NaiveAdverse EffectsDual Therapy
Funding
Non-IndustryNational Institute of Allergy and Infectious Diseases (NIAID)
References
- Haubrich RH, Riddler SA, DiRienzo AG, et al. Metabolic outcomes in a randomized trial of nucleoside, nonnucleoside and protease inhibitor-sparing regimens for initial HIV treatment. AIDS. 2009;23:1109-18.
- Hulgan T, Haubrich R, Riddler SA, et al. European mitochondrial DNA haplogroups and metabolic changes during antiretroviral therapy in AIDS Clinical Trials Group Study A5142. AIDS. 2011;25:37-47.
- Riddler SA, Haubrich R, DiRienzo AG, et al. Class-sparing regimens for initial treatment of HIV-1 infection. N Engl J Med. 2008;358:2095-106.
Common TitleBMS 019 Industry
Official Title A Double-Blind Comparison of Zidovudine (AZT) Versus Stavudine (d4T; BMY 27857) for the Treatment of Patients With HIV Infection Who Have Absolute CD4 Lymphocyte Counts Between 50 and 500 Cells/mm3
Phase Phase III
ClinicalTrials.gov NCT00002307
Treatments
Stavudine
, Stavudine
Tradename:ZeritOther Names:d4TClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Zidovudine
Zidovudine
Tradename:RetrovirOther Names:ZDVClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Categories Treatment-ExperiencedMonotherapy
Funding
IndustryBristol-Myers Squibb
References
- Spruance SL, Pavia AT, Mellors JW, et al. Clinical efficacy of monotherapy with stavudine compared with zidovudine in HIV-infected, zidovudine-experienced patients. A randomized, double-blind, controlled trial. Bristol-Myers Squibb Stavudine/019 Study Group. Ann Intern Med. 1997;126:355-63.
Official Title A Phase 3, Randomized, Multicenter Study of the Treatment of Antiretroviral-Naive HIV-1 Infected Subjects Comparing Tenofovir Disoproxil Fumarate and Emtricitabine in Combination With Efavirenz vs Combivir (Lamivudine/Zidovudine) and Efavirenz
Phase Phase III
ClinicalTrials.gov NCT00112047
Treatments
Zidovudine
, Zidovudine
Tradename:RetrovirOther Names:ZDVClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Efavirenz
, Efavirenz
Tradename:SustivaOther Names:EFVClass:Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)Emtricitabine
, Emtricitabine
Tradename:EmtrivaOther Names:FTCClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Zidovudine-Lamivudine
, Zidovudine-Lamivudine
Tradename:CombivirOther Names:ZDV-3TCClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Efavirenz-Tenofovir DF-Emtricitabine
Efavirenz-Tenofovir DF-Emtricitabine
Tradename:AtriplaOther Names:EFV-TDF-FTC, Efavirenz-Tenofovir disoproxil fumarate-EmtricitabineClass:Single-Tablet RegimensCategories Treatment-NaiveResistance/Virological Failure
Funding
IndustryGilead Sciences
References
- Arribas JR, Pozniak AL, Gallant JE, et al. Tenofovir disoproxil fumarate, emtricitabine, and efavirenz compared with zidovudine/lamivudine and efavirenz in treatment-naive patients: 144-week analysis. J Acquir Immune Defic Syndr. 2008;47:74-8.
- Gallant JE, DeJesus E, Arribas JR, et al. Tenofovir DF, emtricitabine, and efavirenz vs. zidovudine, lamivudine, and efavirenz for HIV. N Engl J Med. 2006;354:251-60.
- Margot NA, Enejosa J, Cheng AK, Miller MD, McColl DJ; Study 934 Team. Development of HIV-1 drug resistance through 144 weeks in antiretroviral-naïve subjects on emtricitabine, tenofovir disoproxil fumarate, and efavirenz compared with lamivudine/zidovudine and efavirenz in study GS-01-934. J Acquir Immune Defic Syndr. 2009;52:209-21.
- Pozniak AL, Gallant JE, DeJesus E, et al. Tenofovir disoproxil fumarate, emtricitabine, and efavirenz versus fixed-dose zidovudine/lamivudine and efavirenz in antiretroviral-naive patients: virologic, immunologic, and morphologic changes--a 96-week analysis. J Acquir Immune Defic Syndr. 2006;43:535-40.
Common TitleMK 035 Non-Industry Industry
Official Title Simultaneous vs sequential initiation of therapy with indinavir, zidovudine, and lamivudine for HIV-1 infection
ClinicalTrials.gov NCT00002155
Treatments
Zidovudine
, Zidovudine
Tradename:RetrovirOther Names:ZDVClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Indinavir
Indinavir
Tradename:CrixivanOther Names:IDVClass:Protease Inhibitors (PI)Categories Treatment-ExperiencedDual TherapyResistance/Virological FailureMonotherapy
Funding
IndustryMerck Research Laboratories
Non-IndustryNational Institute of Allergy and Infectious Diseases (NIAID)
References
- Günthard HF, Havlir DV, Fiscus S, et al. Residual human immunodeficiency virus (HIV) Type 1 RNA and DNA in lymph nodes and HIV RNA in genital secretions and in cerebrospinal fluid after suppression of viremia for 2 years. J Infect Dis. 2001;183:1318-27.
- Gulick RM, Mellors JW, Havlir D, et al. 3-year suppression of HIV viremia with indinavir, zidovudine, and lamivudine. Ann Intern Med. 2000;133:35-9.
- Gulick RM, Mellors JW, Havlir D, et al. Simultaneous vs sequential initiation of therapy with indinavir, zidovudine, and lamivudine for HIV-1 infection: 100-week follow-up. JAMA. 1998;280:35-41.
- Gulick RM, Mellors JW, Havlir D, et al. Treatment with indinavir, zidovudine, and lamivudine in adults with human immunodeficiency virus infection and prior antiretroviral therapy. N Engl J Med. 1997;337:734-9.
Common TitleNUCA 3001 Industry
Official Title A Randomized, Double-Blind Multicenter Trial to Compare the Safety and Efficacy of Lamivudine (3TC; GR109714X) Monotherapy Versus Zidovudine (AZT) Monotherapy Versus 3TC Administered With AZT in the Treatment of HIV-1 Infected Patients Who Are AZT Naive (< 4 Weeks) With CD4 Cell Counts of 200-500 Cells/mm3
Phase Phase III
ClinicalTrials.gov NCT00002320
Treatments
Zidovudine
, Zidovudine
Tradename:RetrovirOther Names:ZDVClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Lamivudine
, Lamivudine
Tradename:EpivirOther Names:3TCClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Zidovudine-Lamivudine
Zidovudine-Lamivudine
Tradename:CombivirOther Names:ZDV-3TCClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Categories Treatment-NaiveTreatment-ExperiencedDual TherapyMonotherapyResistance/Virological FailureSwitch/Simplification
Funding
IndustryGlaxo Wellcome
References
- Eron JJ Jr. The treatment of antiretroviral-naive subjects with the 3TC/zidovudine combination: a review of North American (NUCA 3001) and European (NUCB 3001) trials. AIDS. 1996;10 Suppl 5:S11-9.
- Eron JJ, Benoit SL, Jemsek J, et al. Treatment with lamivudine, zidovudine, or both in HIV-positive patients with 200 to 500 CD4+ cells per cubic millimeter. North American HIV Working Party. N Engl J Med. 1995;333:1662-9.
- Kuritzkes DR, Quinn JB, Benoit SL, et al. Drug resistance and virologic response in NUCA 3001, a randomized trial of lamivudine (3TC) versus zidovudine (ZDV) versus ZDV plus 3TC in previously untreated patients. AIDS. 1996;10:975-81.
- Kuritzkes DR, Shugarts D, Bakhtiari M, et al. Emergence of dual resistance to zidovudine and lamivudine in HIV-1-infected patients treated with zidovudine plus lamivudine as initial therapy. J Acquir Immune Defic Syndr. 2000;23:26-34.
- Phillips AN, Eron JJ, Bartlett JA, et al. HIV-1 RNA levels and the development of clinical disease. North American Lamivudine HIV Working Group. AIDS. 1996;10:859-65.
Common TitleSTART I Industry
Official Title An Open Label, Randomized, Comparative Study of Zerit (d4T) + Epivir (3TC) + Crixivan Versus Retrovir (AZT) + Epivir (3TC) + Crixivan in HIV-Infected, Antiretroviral Naive Subjects With CD4 Cell Counts of 200-700 Cells/mm3 and HIV RNA Baseline Copy Number of ≥10,000 Copies/ml
ClinicalTrials.gov NCT00002369
Treatments
Stavudine
, Stavudine
Tradename:ZeritOther Names:d4TClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Zidovudine
, Zidovudine
Tradename:RetrovirOther Names:ZDVClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Indinavir
Indinavir
Tradename:CrixivanOther Names:IDVClass:Protease Inhibitors (PI)Categories Treatment-Naive
Funding
IndustryBristol-Myers Squibb
References
- Squires KE, Gulick R, Tebas P, et al. A comparison of stavudine plus lamivudine versus zidovudine plus lamivudine in combination with indinavir in antiretroviral naive individuals with HIV infection: selection of thymidine analog regimen therapy (START I). AIDS. 2000;14:1591-600.