SPL7013 Gel (VivaGel®) Retains Potent HIV-1 and HSV-2 Inhibitory Activity following Vaginal Administration in Humans
Author Information
Author(s): Clare F. Price, David Tyssen, Secondo Sonza, Ashley Davie, Sonya Evans, Gareth R. Lewis, Shirley Xia, Tim Spelman, Peter Hodsman, Thomas R. Moench, Andew Humberstone, Jeremy R.A. Paull, Gilda Tachedjian
Primary Institution: Starpharma Pty Ltd, Melbourne, Victoria, Australia
Hypothesis
Does SPL7013 Gel retain its antiviral activity after vaginal administration in healthy women?
Conclusion
SPL7013 Gel demonstrated high levels of HIV-1 and HSV-2 inhibitory activity for at least 3 hours after vaginal administration, with some activity maintained for up to 24 hours.
Supporting Evidence
- SPL7013 Gel was well tolerated with no significant adverse events reported.
- High levels of antiviral activity were retained in the presence of seminal plasma.
- Median inhibition of HIV-1 was 96% immediately after dosing.
- At 3 hours post-dose, HIV-1 inhibition remained at 96%.
- More than 70% inhibition of HIV-1 and HSV-2 was observed with >0.5 mg SPL7013 in CVF samples.
- Six out of eleven women maintained >90% inhibition of HIV-1 and HSV-2 at 24 hours post-dose.
- Statistical analysis showed significant results for HIV-1 and HSV-2 inhibition at various time points.
- The SoftCup method effectively collected CVF samples without significant dilution.
Takeaway
The study shows that a gel used to prevent HIV and herpes can work well for several hours after being applied inside the vagina.
Methodology
The study was an open-label, single center, randomized, 5-period, cross-over study where participants received 5 doses of SPL7013 Gel and CVF samples were collected at various time points.
Potential Biases
Potential bias due to the open-label design and the self-sampling method.
Limitations
The study's sample size was small, and the dilution of CVF samples may underestimate the actual antiviral activity.
Participant Demographics
Female volunteers aged 18-45, HIV-uninfected, using hormonal contraception.
Statistical Information
P-Value
p=0.005
Confidence Interval
95% (95, 97)
Statistical Significance
p≤0.003
Digital Object Identifier (DOI)
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