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Common TitleACTG 116 Non-Industry
Official Title Comparison of 2',3'-Dideoxyinosine (ddI) (BMY-40900) and Zidovudine in Therapy of Patients With HIV Infection
Phase Phase II
ClinicalTrials.gov NCT00000979
Treatments
Didanosine
Didanosine
Tradename:VidexOther Names:ddIClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Categories Treatment-NaiveTreatment-ExperiencedMonotherapy
Funding
Non-IndustryNational Institute of Allergy and Infectious Diseases (NIAID)
References
- Dolin R, Amato DA, Fischl MA, et al. Zidovudine compared with didanosine in patients with advanced HIV type 1 infection and little or no previous experience with zidovudine. AIDS Clinical Trials Group. Arch Intern Med. 1995;155:961-74.
Common TitleACTG 116B/117 Non-Industry
Official Title A Phase II Efficacy Study Comparing 2',3'-Dideoxyinosine (ddI) (BMY-40900) and Zidovudine Therapy of Patients With HIV Infection Who Have Been on Long Term Zidovudine Treatment
Phase Phase II
ClinicalTrials.gov NCT00000671
Treatments
Didanosine
Didanosine
Tradename:VidexOther Names:ddIClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Categories Treatment-ExperiencedMonotherapy
Funding
Non-IndustryNational Institute of Allergy and Infectious Diseases (NIAID)
References
- Kahn JO, Lagakos SW, Richman DD, et al. A controlled trial comparing continued zidovudine with didanosine in human immunodeficiency virus infection. The NIAID AIDS Clinical Trials Group. N Engl J Med. 1992;327:581-7.
Common TitleACTG 143 Non-Industry
Official Title A Phase I/II, Open Label Study to Evaluate the Antiviral Potential of Combination Zidovudine and 2' 3'-Dideoxyinosine (Didanosine) in Patients With Asymptomatic HIV Disease
Phase Phase I
ClinicalTrials.gov NCT00000656
Treatments
Didanosine
Didanosine
Tradename:VidexOther Names:ddIClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Categories Treatment-NaiveTreatment-ExperiencedDual TherapyMonotherapy
Funding
Non-IndustryNational Institute of Allergy and Infectious Diseases (NIAID)
References
- Ragni MV, Amato DA, LoFaro ML, et al. Randomized study of didanosine monotherapy and combination therapy with zidovudine in hemophilic and nonhemophilic subjects with asymptomatic human immunodeficiency virus-1 infection. AIDS Clinical Trial Groups. Blood. 1995;85:2337-46.
Common TitleACTG 193 Non-Industry
Official Title A Randomized, Double-Blind, Three-Arm Study Comparing Combination to Monthly Alternating Nucleoside Therapy for the Treatment of Advanced HIV Disease (CD4 <= 50/mm3) With a Prior History of Nucleoside Therapy
Phase Phase II
ClinicalTrials.gov NCT00001029
Treatments
Didanosine
Didanosine
Tradename:VidexOther Names:ddIClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Categories Treatment-ExperiencedDual Therapy
Funding
Non-IndustryNational Institute of Allergy and Infectious Diseases (NIAID)
References
- Henry K, Erice A, Tierney C, et al. A randomized, controlled, double-blind study comparing the survival benefit of four different reverse transcriptase inhibitor therapies (three-drug, two-drug, and alternating drug) for the treatment of advanced AIDS. AIDS Clinical Trial Group 193A Study Team. J Acquir Immune Defic Syndr Hum Retrovirol. 1998;19:339-49.
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
Didanosine
Didanosine
Tradename:VidexOther Names:ddIClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Categories PharmacologyTreatment-ExperiencedAdverse EffectsDual Therapy
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.
- Hughes MD, Johnson VA, Hirsch MS, et al. Monitoring plasma HIV-1 RNA levels in addition to CD4+ lymphocyte count improves assessment of antiretroviral therapeutic response. ACTG 241 Protocol Virology Substudy Team. Ann Intern Med. 1997;126:929-38.
Common TitleAI454-143 Industry
Official Title A Randomized, Double-Blind Study of the Antiviral Activity of Once-Daily and Twice-Daily Dosing of Didanosine in Combination With Twice-Daily Dosing of Stavudine in HIV-Infected Subjects
ClinicalTrials.gov NCT00002207
Treatments
Didanosine
Didanosine
Tradename:VidexOther Names:ddIClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Categories Treatment-Naive
Funding
IndustryBristol-Myers Squibb
References
- Mobley JE, Pollard RB, Schrader S, Adler MH, Kelleher T, McLaren C. Virological and immunological responses to once-daily dosing of didanosine in combination with stavudine. AI454-143 Team. AIDS. 1999 Jul 30;13:F87-93.
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 TitleCPCRA 002 Non-Industry
Official Title A Prospective, Randomized, Open-Label, Comparative Trial of Dideoxyinosine (ddI) Versus Dideoxycytidine (ddC) in HIV-Infected Patients Who Are Intolerant of or Who Have Failed Zidovudine (AZT) Therapy
ClinicalTrials.gov NCT00000969
Treatments
Didanosine
Didanosine
Tradename:VidexOther Names:ddIClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Categories PharmacologyTreatment-ExperiencedAdverse EffectsMonotherapy
Funding
Non-IndustryNational Institute of Allergy and Infectious Diseases (NIAID)
References
- Abrams DI, Goldman AI, Launer C, et al. A comparative trial of didanosine or zalcitabine after treatment with zidovudine in patients with human immunodeficiency virus infection. The Terry Beirn Community Programs for Clinical Research on AIDS. N Engl J Med. 1994;330:657-62.
Common TitleCPCRA007 Non-Industry
Official Title A Randomized, Comparative Trial of Zidovudine (AZT) Versus AZT Plus Didanosine (ddI) Versus AZT Plus Dideoxycytidine (ddC) in HIV-Infected Patients
Phase Phase III
ClinicalTrials.gov NCT0000102
Treatments
Didanosine
Didanosine
Tradename:VidexOther Names:ddIClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Categories Treatment-NaiveTreatment-ExperiencedDual TherapyMonotherapy
Funding
Non-IndustryNational Institute of Allergy and Infectious Diseases (NIAID)
References
- Saravolatz LD, Winslow DL, Collins G, et al. Zidovudine alone or in combination with didanosine or zalcitabine in HIV-infected patients with the acquired immunodeficiency syndrome or fewer than 200 CD4 cells per cubic millimeter. Investigators for the Terry Beirn Community Programs for Clinical Research on AIDS. N Engl J Med. 1996;335:1099-106.
Common TitleGESIDA 3903 Non-Industry
Official Title A Multicenter, Randomized, Open Label, Clinical Trial Comparing a QD Regimen of Didanosine, Lamivudine and Efavirenz With a Standard BID Regimen of Zidovudine, Lamivudine and Efavirenz in the Starting Treatment of Human Immunodeficiency Virus Infection (GESIDA 39/03)
Phase Phase IV
ClinicalTrials.gov NCT00256828
Treatments
Didanosine
, Didanosine
Tradename:VidexOther Names:ddIClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Zidovudine-Lamivudine
Zidovudine-Lamivudine
Tradename:CombivirOther Names:ZDV-3TCClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Categories Treatment-Naive
Funding
Non-IndustryClinical Trial Agency of HIV Study Group
References
- Berenguer J, González J, Ribera E, et al. Didanosine, lamivudine, and efavirenz versus zidovudine, lamivudine, and efavirenz for the initial treatment of HIV type 1 infection: final analysis (48 weeks) of a prospective, randomized, noninferiority clinical trial, GESIDA 3903. Clin Infect Dis. 2008;47:1083-92.