National Toxicology Program

National Toxicology Program
http://ntp.niehs.nih.gov/go/ts-m000049

Testing Status of AZT+3TC+NVP combination - M000049

 

CASRN: AZT3TCCOMBO

Synonyms/Common Names

  • AZT + 3TC (Lamivudine) + NVP (Nevirapine)

Secondary:

  • 134678-17-4 - 3TC (AIDS initiative)
  • 30516-87-1 - 3'-Azido-3'-deoxythymidine (AIDS)
  • 30516-87-1 - AZT transplacental carcinogenesis study
  • 129618-40-2 - Nevirapine

Known Uses

Special combination to study AIDS therapeutics

Short-Term Toxicity

  • 28 days (Gavage)  (C20310B)  Completed 
    • Mice: C3B6F1-+/TRP53<TM1BRD> (NCTR)
    • Dose: 0, 80, 160, or 240 mg/kg bwt.

Long-Term Carcinogenicity

  • 45 weeks (Gavage)  (C20310B)  Completed 
    • GMM-16 (NIH Number: 14-5973)  (Peer Review Approval 02/00/2012A )
      Toxicology and Carcinogenicity Study of Mixtures of 3'-Azido-3'-Deoxythymidine (AZT), Lamivudine (3TC), and Nevirapine (NVP) (CASRNs 30516-87-1, 134678-17-4, 129618-40-2) in Genetically Modified C3B6.129F1-Trp53tm1Brd N12 Haploinsufficient Mice (In Utero and Postnatal Gavage Studies)
    • Mice: C3B6F1-+/TRP53<TM1BRD> (NCTR)
    • Dose: 25 animals/group; dose combinations AZT, 3TC, NVP, AZT/3TC, AZT/3TC/NVP.

Genetic Toxicology

  • Micronucleus  (A40581)  Completed 
    • Mice: Swiss CD-1
    • Male Positive 
    • Female NA 
  • Micronucleus  (A62246)  Completed 
    • Mice: Swiss CD-1
    • Male Negative 
  • Micronucleus  (A62527)  Completed 
    • Mice: Swiss CD-1
    • Male Negative 
  • Micronucleus  (A75317)  Completed 
    • Mice: Swiss CD-1
    • Male Positive 
  • Micronucleus  (A78223)  Completed 
    • Mice: Swiss CD-1
    • Male Negative 
  • Micronucleus  (A83804)  Completed 
    • Mice: Swiss CD-1
    • Male Positive 

Organ Systems Toxicity

  • 2nd generation Continuous Breeding (Legacy) (Gavage)  (RACB20204)  Completed 
    • Male and Female Mice: Swiss CD-1
    • Dose: 0, 25/50, 35.5/75, 50/100, OR 75/150 MG/KG/DAY.
  • 6 to 16 GD Conventional Teratology (Gavage)  (TER20203)  Completed 
    • Citation: Developmental Toxicity Evaluation of 3'-Azido-3'-deoxythymidine (AZT; CASRN 30516-87-1) and (-) 2', 3'-Dideoxy-3'-thiacytidine (3TC; CASRN 134678-17-4) Co-administered by Gavage to Swiss Albino (CD-1®) Mice on Gestational Days 6 through 16
    • Citation: Developmental Toxicity Evaluation of 3'-Azido-3'-deoxythymidine (AZT; CASRN 30516-87-1) and (-)2',3'-Dideoxy-3'-thiacytidine (3TC; CASRN 134678-17-4) Co-administered by Gavage to Swiss Albino (CD-1®) Mice on Gestational Days 6 Through 16
    • Female Mice: Swiss CD-1
    • Dose: 0/0, 0/50, 0/100, 0/200, 0/1000, 100/0, 200/0, 400/0, 100/50, 200/100, 400/200 AND 400/1000 MG/KG/DAY (AZT/3TC).
  • 6 to 16 GD Teratology Pilot Studies (Gavage)  (TRP20202)  Completed 
    • Female Mice: Swiss CD-1
    • Dose: 0/0, 0/200, 0/1000, 100/50, 200/100, 400/0, 400/200, 400/400, OR 400/1000 AZT/3TC MG/KG/DAY.
NTP is located at the National Institute of Environmental Health Sciences, part of the National Institutes of Health.