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Common TitleNUCA 3001
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 Retrovir

Zidovudine

Tradename:RetrovirOther Names:ZDVClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)
,
Lamivudine
Lamivudine Epivir

Lamivudine

Tradename:EpivirOther Names:3TCClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)
,
Zidovudine-Lamivudine
Zidovudine-Lamivudine Combivir

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

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