Table 2.
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