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
Elvitegravir-Cobicistat-Tenofovir DF-Emtricitabine Stribild
Rilpivirine-Tenofovir alafenamide-Emtricitabine Odefsey
Rilpivirine-Tenofovir DF-Emtricitabine Complera
Enfuvirtide Fuzeon
Fostemsavir Rukobia
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Maraviroc Selzentry
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Abacavir-Lamivudine Epzicom
Abacavir-Lamivudine-Zidovudine Trizivir
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Tenofovir alafenamide-Emtricitabine Descovy
Tenofovir DF Viread
Tenofovir DF-Emtricitabine Truvada and Multiple Generics
Doravirine Pifeltro
Etravirine Intelence
Rilpivirine Edurant
Atazanavir Reyataz
Atazanavir-Cobicistat Evotaz
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Official Title A Phase III, Multicenter, Randomized, Open-Label Study to Compare Antiretroviral Activity and Tolerability of Three Different Combination Regimens (Efavirenz [DMP 266] + Indinavir, Efavirenz [DMP 266] + Zidovudine + Lamivudine, Indinavir + Zidovudine + Lamivudine) in HIV-Infected Patients
Phase Phase III
ClinicalTrials.gov NCT00002410
Treatments
Indinavir
, Indinavir
Tradename:CrixivanOther Names:IDVClass:Protease Inhibitors (PI)Efavirenz
Efavirenz
Tradename:SustivaOther Names:EFVClass:Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)Categories Treatment-NaiveTreatment-Experienced
Funding
IndustryDupont Merck
References
- Staszewski S, Morales-Ramirez J, Tashima KT, et al. Efavirenz plus zidovudine and lamivudine, efavirenz plus indinavir, and indinavir plus zidovudine and lamivudine in the treatment of HIV-1 infection in adults. Study 006 Team. N Engl J Med. 1999;341:1865-73.
Common Title028 Industry
Official Title Twelve-Month Study in HIV-1 Seropositive Retroviral-Naive Patients to Compare the Safety and Efficacy of Indinavir (MK-639) and Zidovudine (AZT) Administered Concomitantly to Indinavir (MK-639) Alone and Zidovudine (AZT) Alone
ClinicalTrials.gov NCT00002443
Treatments
Indinavir
Indinavir
Tradename:CrixivanOther Names:IDVClass:Protease Inhibitors (PI)Categories Treatment-NaiveDual TherapyMonotherapy
Funding
IndustryMerck Sharp & Dohme Corp
References
- Lewi DS, Suleiman JM, Uip DE, et al. Randomized, double-blind trial comparing indinavir alone, zidovudine alone and indinavir plus zidovudine in antiretroviral therapy-naive HIV-infected individuals with CD4 cell counts between 50 and 250/mm3. Rev Inst Med Trop Sao Paulo. 2000;42:27-36.
Common Title039 Industry
Official Title A Six-Month Safety and Antiviral Study in HIV-1 Seropositive, AZT-Experienced Patients With CD4 Counts Less Than or Equal to 50 Cells/mm3 to Evaluate Indinavir (MK-639) Alone Versus Zidovudine (AZT) and 3TC Versus the Combination of Indinavir (MK-639) With AZT/3TC
Phase Phase III
ClinicalTrials.gov NCT00002155
Treatments
Indinavir
Indinavir
Tradename:CrixivanOther Names:IDVClass:Protease Inhibitors (PI)Categories Treatment-ExperiencedPharmacologyAdverse EffectsDual TherapyMonotherapy
Funding
IndustryMerck Sharp & Dohme Corp
References
- Hirsch M, Steigbigel R, Staszewski S, et al. A randomized, controlled trial of indinavir, zidovudine, and lamivudine in adults with advanced human immunodeficiency virus type 1 infection and prior antiretroviral therapy. J Infect Dis. 1999;180:659-65.
- Hirsch MS, Steigbigel RT, Staszewski S, et al. Long-term efficacy, safety, and tolerability of indinavir-based therapy in protease inhibitor-naive adults with advanced HIV infection. Clin Infect Dis. 2003;37:1119-24.
Common Title054/069 Industry
Official Title A Multicenter, Open-Label, Randomized, 24-Week Study to Compare the Safety and Activity of Indinavir Sulfate, 800 Mg q 8 h Versus 1,200 Mg q 12 h in Combination With Zidovudine and 3TC
Phase Phase III
ClinicalTrials.gov NCT00002208
Treatments
Indinavir
, Indinavir
Tradename:CrixivanOther Names:IDVClass:Protease Inhibitors (PI)Zidovudine-Lamivudine
Zidovudine-Lamivudine
Tradename:CombivirOther Names:ZDV-3TCClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Categories Resistance/Virological FailureTreatment-Experienced
Funding
IndustryMerck Sharp & Dohme Corp
References
- Haas DW, Arathoon E, Thompson MA, et al. Comparative studies of two-times-daily versus three-times-daily indinavir in combination with zidovudine and lamivudine. AIDS. 2000;14:1973-8.
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 333 Non-Industry
Official Title The Antiviral Effect of Switching From Hard Capsule Saquinavir (SQVhc) to the Soft Gelatin Capsule of Saquinavir (SQVsc) Versus Switching to Indinavir (IDV) After 1 Year of Saquinavir Use
Phase Phase II
ClinicalTrials.gov NCT00000848
Treatments
Indinavir
, Indinavir
Tradename:CrixivanOther Names:IDVClass:Protease Inhibitors (PI)Saquinavir
Saquinavir
Tradename:InviraseOther Names:SQVClass:Protease Inhibitors (PI)Categories Resistance/Virological FailureTreatment-ExperiencedSwitch/Simplification
Funding
Non-IndustryNational Institute of Allergy and Infectious Diseases (NIAID)
References
- Para MF, Glidden DV, Coombs RW, et al. Baseline human immunodeficiency virus type 1 phenotype, genotype, and RNA response after switching from long-term hard-capsule saquinavir to indinavir or soft-gel-capsule saquinavir in AIDS clinical trials group protocol 333. J Infect Dis. 2000;182:733-43.
- Sevin AD, DeGruttola V, Nijhuis M, et al. Methods for investigation of the relationship between drug-susceptibility phenotype and human immunodeficiency virus type 1 genotype with applications to AIDS clinical trials group 333. J Infect Dis. 2000;182:59-67.
Common TitleACTG 343 Non-Industry
Official Title A Prospective Randomized Double-Blind Trial of Three Maintenance Regimens for HIV-Infected Subjects Receiving Induction Therapy With Zidovudine, Lamivudine and Indinavir
Phase Phase II
ClinicalTrials.gov NCT00001084
Treatments
Indinavir
, Indinavir
Tradename:CrixivanOther Names:IDVClass:Protease Inhibitors (PI)Zidovudine-Lamivudine
Zidovudine-Lamivudine
Tradename:CombivirOther Names:ZDV-3TCClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Categories Resistance/Virological FailureTreatment-ExperiencedDual TherapyMonotherapyPharmacologyGeneral Pharmacology
Funding
Non-IndustryNational Institute of Allergy and Infectious Diseases (NIAID)
References
- Havlir DV, Bassett R, Levitan D, et al. Prevalence and predictive value of intermittent viremia with combination hiv therapy. JAMA. 2001;286:171-9.
- Havlir DV, Hellmann NS, Petropoulos CJ, et al. Drug susceptibility in HIV infection after viral rebound in patients receiving indinavir-containing regimens. JAMA. 2000;283:229-34.
- Havlir DV, Marschner IC, Hirsch MS, et al. Maintenance antiretroviral therapies in HIV infected patients with undetectable plasma HIV RNA after triple-drug therapy. AIDS Clinical Trials Group Study 343 Team. N Engl J Med. 1998;339:1261-8.
- Zhou XJ, Havlir DV, Richman DD, et al. Plasma population pharmacokinetics and penetration into cerebrospinal fluid of indinavir in combination with zidovudine and lamivudine in HIV-1-infected patients. AIDS. 2000;14:2869-76.
Common TitleACTG 370 Non-Industry
Official Title Virologic and Immunologic Activity of Continued Lamivudine (3TC) vs Delavirdine (DLV) in Combination With Indinavir (IDV) and Zidovudine (ZDV) or Stavudine (d4T) in 3TC-Experienced Subjects
Phase Phase II
ClinicalTrials.gov NCT00000882
Treatments
Stavudine
, Stavudine
Tradename:ZeritOther Names:d4TClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Indinavir
, Indinavir
Tradename:CrixivanOther Names:IDVClass:Protease Inhibitors (PI)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-ExperiencedResistance/Virological FailureTreatment-NaiveDual Therapy
Funding
Non-IndustryNational Institute of Allergy and Infectious Diseases (NIAID)
References
- Ickovics JR, Cameron A, Zackin R, et al. Consequences and determinants of adherence to antiretroviral medication: results from Adult AIDS Clinical Trials Group protocol 370. Antivir Ther. 2002;7:185-93.
- Kuritzkes DR, Bassett RL, Hazelwood JD, et al. Rate of thymidine analogue resistance mutation accumulation with zidovudine- or stavudine-based regimens. J Acquir Immune Defic Syndr. 2004;36:600-3.
- Kuritzkes DR, Bassett RL, Johnson VA, et al. Continued lamivudine versus delavirdine in combination with indinavir and zidovudine or stavudine in lamivudine-experienced patients: results of Adult AIDS Clinical Trials Group protocol 370. AIDS. 2000;14:1553-61.
Common TitleACTG 373 Non-Industry
Official Title A Phase II Study of 1) Amprenavir (141W94/VX478) Plus 3TC Plus ZDV (or d4T) or 2) IDV Plus NVP Plus 3TC Plus d4T in Subjects Previously Treated With Amprenavir and 3) Other Treatment Regimens (Observational ARM) in Subjects Previously Treated With Amprenavir
Phase Phase II
ClinicalTrials.gov NCT00001095
Treatments
Stavudine
, Stavudine
Tradename:ZeritOther Names:d4TClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Indinavir
Indinavir
Tradename:CrixivanOther Names:IDVClass:Protease Inhibitors (PI)Categories Treatment-Experienced
Funding
Non-IndustryNational Institute of Allergy and Infectious Diseases (NIAID)
References
- Gulick RM, Smeaton LM, D'Aquila RT, et al. Indinavir, nevirapine, stavudine, and lamivudine for human immunodeficiency virus-infected, amprenavir-experienced subjects: AIDS Clinical Trials Group protocol 373. J Infect Dis. 2001;183:715-21.
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 5055 Industry
Official Title A Multicenter, Open-Label, Randomized, Study to Compare the Efficacy and Safety of Indinavir 800 mg b.i.d. Plus Ritonavir 100 mg b.i.d. Plus Two NRTIs vs. Nelfinavir 1250 mg b.i.d. Plus Two NRTIs in HIV-1 Seropositive Patients Who Have Failed or Are Intolerant to an NNRTI Containing Regimen
Phase Phase II
ClinicalTrials.gov NCT00541463
Treatments
Indinavir
, Indinavir
Tradename:CrixivanOther Names:IDVClass:Protease Inhibitors (PI)Ritonavir
Ritonavir
Tradename:NorvirOther Names:RTVClass:Pharmacokinetic EnhancersCategories PharmacologyTreatment-ExperiencedGeneral Pharmacology
Funding
IndustryMerck Sharp & Dohme Corp
References
- Acosta EP, Wu H, Hammer SM, et al. Comparison of two indinavir/ritonavir regimens in the treatment of HIV-infected individuals. J Acquir Immune Defic Syndr. 2004;37:1358-66.
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 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 TitleMK-0639 Industry
Official Title A Multiclinic, Open Study to Evaluate the Ability of the Combination of Indinavir, Zidovudine and Lamivudine to Result in Sustained Suppression of HIV-1 in Asymptomatic HIV-1 Seropositive Patients
Phase Phase IV
ClinicalTrials.gov NCT00002179
Treatments
Indinavir
Indinavir
Tradename:CrixivanOther Names:IDVClass:Protease Inhibitors (PI)Funding
IndustryMerck Sharp & Dohme Corp
References
No references available for this clinical trial
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.
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ACTG 388 - February 25, 2020