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Common TitleACTG 320
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 Retrovir

Zidovudine

Tradename:RetrovirOther Names:ZDVClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)
,
Indinavir
Indinavir Crixivan

Indinavir

Tradename:CrixivanOther Names:IDVClass:Protease Inhibitors (PI)
,
Zidovudine-Lamivudine
Zidovudine-Lamivudine Combivir

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.
    [PubMed Abstract]
  • 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.
    [PubMed Abstract]
  • 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.
    [PubMed Abstract]
  • 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.
    [PubMed Abstract]
  • 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
    [PubMed Abstract]

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