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Testing Status of AZT/Drug Combinations Transplacental Carcinogenesis Study M020005



Synonyms/Common Names


Short-Term Toxicity

  • 28 days (In Utero)  (C20311)  Completed 
    • Mice: B6C3F1/NCTR BR (C57BL/6N x C3H/HEN MTV-)

Long-Term Carcinogenicity

  • 2 years (In Utero)  (C20311)  Completed 
    • TR-569 (NIH Number: 11-5911)
      Toxicology and Carcinogenesis Studies of Mixtures of 3'-Azido-3'-Deoxythymidine (AZT), Lamivudine (3TC), Nevirapine (NVP), and Nelfinavir Mesylate (NFV) (CASRNs 30516-87-1, 134678-17-4, 129618-40-2, 159989-65-8) in B6C3F1 Mice (Transplacental Exposure Studies)
    • Mice: B6C3F1/NCTR BR (C57BL/6N x C3H/HEN MTV-)
    • Dose: AZT: 80 (low), 160 (mid), or 240 (high) mg AZT/kg body weight; AZT +3TC: 80/40 (low), 160/80 (mid), or 240/120 (high) mg AZT/3TC/kg body weight; AZT+ 3TC +NVP: 80/40/56 (low), 160/80/112 (mid), or 240/120/168 (high) mg AZT/3TC/NVP/kg body weight; AZT + 3TC + NFV: 80/40/336 (low), 160/80/672 (mid), or 240/120/1, 008 (high) mg AZT/3TC/NFV/kg body weight.