Testing Status of Tricombination FTC:TDF:EFV (1:1.5:3) 13067

CASRN: TRICOMBOHIV

Formula: C19H30N5O10P.C14H9ClF3NO2.C8H10FN3O3S.C4H4O4

Synonyms/Common Names

• Tri-Combo Therapy (TDF/EFV/FTC)
• Tri-combo therapy (TDF/EFV/FTC) (AIDS)

Secondary:

• 154598-52-4 - Efavirenz (EFV)
• 143491-57-0 - Emtricitabine (FTC)
• 202138-50-9 - Tenofovir Disoproxil Fumarate (TDF)

Modified One-Generation

• 8 weeks F0 Generation (Gavage)  (MOG13067)  On Test 
  • Mice: CD-1 Reg.[Crl:CD1(ICR)]
  • Dose: FTC:TDF:EFV (1:1.5:3) are 0:0:0, 12.5:18.5:37.5, 25:37.5:75, or 50:75:150 mg/kg/day.
• 13 weeks Subchronic (Gavage)  (MOG13067B)  Data in Review 
  • Mice: CD-1 Reg.[Crl:CD1(ICR)]
  • Dose: FTC:TDF:EFV (1:1.5:3) are 0:0:0, 12.5:18.5:37.5, 25:37.5:75, or 50:75:150 mg/kg/day.
• GD 15, PND 4, and PND 15 Maternal Transfer (Gavage)  (MOG13067C)  Data in Review 
  • Biological Sampling for Subchronic Mouse Study MOG13067B
  • Mice: CD-1 Reg.[Crl:CD1(ICR)]
  • Dose: FTC:TDF:EFV (1:1.5:3) are 0:0:0, 12.5:18.5:37.5, 25:37.5:75, or 50:75:150 mg/kg/day.

Special Studies

• GD 5 - GD 15 Preliminary Toxicokinetic Study (Gavage)  (K13067)  Completed 
  • Mice
  • Dose: 50:75:150 MG/KG.

Genetic Toxicology

• 20 days (samples at weaning) Micronucleus (Gavage)  (G18001)  Completed 
  • Mice: CD-1 Reg.[Crl:CD1(ICR)]
• 20 days (pups) Micronucleus (Transplacental & Gavage)  (G18001B)  Completed 
  • Mice: CD-1 Reg.[Crl:CD1(ICR)]

Organ Systems Toxicity

• GD 5 to GD 15 Maternal Transfer (Gavage)  (R13067D)  Report in Preparation 
  • Mice: CD-1
  • Dose: Emtricitabine 50 mg/kg/day, Tenofovir 75 mg/kg/day, and Efavirenz 150 mg/kg/day.
• GD 5 to GD 18 Teratology Pilot Studies (Gavage)  (R13067)  Report in Preparation 
  • Dose Range-Finding
  • Mice: CD-1