National Toxicology Program

National Toxicology Program
http://ntp.niehs.nih.gov/go/ts-m070066

Testing Status of AZT/Drug Combinations Transplacental/Neonatal Study - M070066

 

CASRN: AIDSDRUGSNEO

Related: AIDSTHERAPEU

Secondary:

  • 134678-17-4 - 3TC (AIDS initiative)
  • 30516-87-1 - 3'-Azido-3'-deoxythymidine (AIDS)
  • 30516-87-1 - AZT transplacental carcinogenesis study
  • 154598-52-4 - Efavirenz (EFV)
  • 159989-65-8 - Nelfinavir mesylate
  • 129618-40-2 - Nevirapine

Known Uses

Study of the effects of drugs used in the treatment of HIV-AIDS on neonates

Short-Term Toxicity

  • 28 days (Gavage)  (C20311B)  Completed 
    • Mice: B6C3F1

Long-Term Carcinogenicity

  • 2 years (Gavage)  (C20311B)  Histopath in progress 
    • Mice: B6C3F1/NCTR BR (C57BL/6N x C3H/HEN MTV-)
    • Dose: 240 (Dams GD 12-20); 40, 26.6, 13.3 (Neonates PND 1-8) mg/kg/bwt AZT+3TC: 240 AZT, 120 3TC (Dams GD 12-20); 40 AZT, 20 3TC; 26.6 AZT, 13.3 3TC; 13.3 AZT, 6.7 3TC (Neonates PND 1-8) mg/kg/bwt AZT+3TC+NVP: 240 AZT, 120 3TC, 168 NVP (Dams GD 12-20); 40 AZT, 20 3TC, 56 NVP; 26.6 AZT, 13.3 3TC, 37.2 NVP; 13.3 AZT, 6.7 3TC, 18.6 NVP (Neonates PND 1-8) mg/kg/bwt AZT+3TC+NVF: 160 AZT, 80 3TC, 672 NFV (Dams GD 12-20); 40 AZT, 20 3TC, 168 NFV; 26.6 AZT, 13.3 3TC, 112 NFV; 13.3 AZT, 6.7 3TC, 56 NFV (Neonates PND 1-8) mg/kg/bwt AZT+3TC+EFV: 160 AZT, 80 3TC, 160 EFV (Dams GD 12-20); 40 AZT, 20 3TC, 40 EFV; 26.6 AZT, 13.3 3TC, 26.6 EFV; 13.3 AZT, 6.7 3TC, 13.3 EFV (Neonates PND 1-8) mg/kg/bwt.
NTP is located at the National Institute of Environmental Health Sciences, part of the National Institutes of Health.