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Testing Status of Tricombination ABC:DTG:3TC 18001

 

CASRN: TRICOMBOHIV2

Synonyms/Common Names

  • Tri-Combo Therapy (ABC/DTG/3TC)
  • Tri-combo therapy (ABC/DTG/3TC) (AIDS)

Secondary:

  • 134678-17-4 - 3TC (AIDS initiative)

Short-Term Toxicity

  • 3 months Subchronic (Gavage)  (C18001)  On Test 
    • Cardiovascular assessments - Female F0 Rats
    • Rats: Hsd:Sprague Dawley SD
    • Dose: 0, 150:12.5:75, 300:25:150 (ABC:DTG:3TC) mg/kg/day.
  • 3 months Subchronic (Not Applicable)  (C18001B)  On Test 
    • Cardiovascular assessments - Male and Female F1 Rats
    • Rats: Hsd:Sprague Dawley SD

Modified One-Generation

  • 8 weeks Dose Range Finding (Gavage)  (MOG18001)  Data in Review 
    • Rats: Hsd:Sprague Dawley SD
    • Dose: ABC:DTG:3TC (12:1:6) are 0:0:0, 50:4.2:25, 100:8.3:50, 250:20.8:125, 400:33.3:200 mg/kg/day.
  • 3 months Subchronic (Gavage)  (MOG18001B)  On Test 
    • Perinatal Subchronic Study
    • Rats: Hsd:Sprague Dawley SD
    • Dose: ABC:DTG:3TC (12:1:6) are 0:0:0, 50:4.2:25, 150:12.5:75, or 300:25:150 mg/kg/day.
  • GD 18 and PND 4 Maternal Transfer (Gavage)  (MOG18001C)  On Test 
    • Biological Sampling
    • Rats: Hsd:Sprague Dawley SD
  • 18 months Neurotoxicology Assessment (Gavage)  (MOG18001D)  On Test 
    • Neurobehavior study of TRICOMBOHIV2 in Harlan Sprague Dawley Rats
    • Male and Female Rats: Hsd:Sprague Dawley SD
    • Dose: ABC:DTG:3TC (12:1:6) are 0:0:0, 50:4.2:25, 150:12.5:75, or 300:25:150 mg/kg/day.

Genetic Toxicology

  • 27 days (dams) Micronucleus (Gavage)  (G18001C)  Completed 
    • Rats: Harlan Sprague-Dawley
  • 27 days (pups) Micronucleus (Transplacental)  (G18001D)  Completed 
    • Rats: Harlan Sprague-Dawley
  • 27 days (dams) Micronucleus (Gavage)  (G18001E)  On Test 
    • Rats: Harlan Sprague-Dawley
  • 27 days (pups) Micronucleus (Transplacental)  (G18001H)  On Test 
    • Rats: Hsd:Sprague Dawley SD
  • 27 days (dams) Pig-a gene mutation (Gavage)  (G18001F)  On Test 
    • Rats: Harlan Sprague-Dawley
  • 27 days (pups) Pig-a gene mutation (Transplacental)  (G18001G)  On Test 
    • Rats: Harlan Sprague-Dawley