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. Author manuscript; available in PMC: 2015 Jun 1.
Published in final edited form as: J Clin Pharmacol. 2014 Mar 28;54(6):603–615. doi: 10.1002/jcph.292

Table 2.

Intravaginal Tenofovir Gel Efficacy in Animal Studies.

Animal
Model
Intravaginal
Inoculate
Treatment Time of
Administration
Treatment Arm Protection
N (Infected
/Total)
%
NHP Multiple SIVmac251 −24h, 0h, 24h, 48h 10% TFV gel 0/4 100
1 ml placebo 2/2 0
NHP Single SIVmac251 −24h, −15m, −24h 10% TFV gel 1/5 80
1% TFV gel 1/5 80
−15m 1% TFV gel 2/5 60
N/A Untreated 5/5 0
NHP Single SIVmac251 −15m 1% TFV gel 1/5 80
−2h 1% TFV gel 3/5 40
−8h 1% TFV gel 1/5 80
−15m Vehicle 1/5 80
N/A Untreated 2/5 60
NHP Single SIVmac251 −15m 1% TFV gel 1/5 80
−2h 1% TFV gel 1/5 80
−8h 1% TFV gel 2/5 60
−15m Vehicle 2/5 60
N/A Untreated 4/5 20
NHP Single SIVmac251 −2h 1% TFV gel 0/5 100
−2h Vehicle 2/5 60
N/A Untreated 2/5 60
NHP Single SIVmac251 −12h 1% TFV gel 5/8 38
−24h 1% TFV gel 8/8 0
−72h, −48h, −24h 1% TFV gel 6/8 25
−12h Vehicle 8/8 0
−24h Vehicle 8/8 0
N/A Untreated 8/8 0
NHP Multiple intravaginal SHIVSF162p3 −30m 5%FTC and 1%TFV gel 0/6 100
Vehicle 5/6 17
Untreated 2/2 0
1% TFV gel 0/6 100
Vehicle 3/3 0
NHP Single SIVmac251 −24h, 0h, 24h, 48h 10% TFV gel 0/5 100
Vehicle 5/5 0
NHP Multiple SHIVSF162P3 −30m, −72h 1% TFV gel 4/6 74
2% HEC gel 9/10 10
BLT mice #1 HIV-1JR-CSF −4h, 4h 1% TFV gel 7/8 88

Adapted from:Gengiah TN, Baxter C, Mansoor LE, Kharsany AB, Abdool Karim SS: A drug evaluation of 1% tenofovir gel and tenofovir disoproxil fumarate tablets for the prevention of HIV infection. Expert Opin Investig Drugs. 2012;21(5):695–715 and Garcia-Lerma JG and Heneine W: Animal models of antiretroviral prophylaxis for HIV prevention. CurrOpin HIV AIDS 2012;7(6):505–513; BLT=bone/liver/thymus, FTC=emtricitabine, HEC= hydroxyethylcellulose, NHP=non-human primate, and TFV=tenofovir