Abstract
| Original language | English |
|---|---|
| Article number | e24095 |
| Number of pages | 12 |
| Journal | PLoS ONE |
| Volume | 6 |
| Issue number | 9 |
| DOIs | |
| Publication status | Published - 2011 |
Cite this
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SPL7013 Gel (VivaGel) retains potent HIV-1 and HSV-2 inhibitory activity following vaginal administration in humans. / Price, Clare F; Tyssen, David; Sonza, Secondo; Davie, Ashley; Evans, Sonya; Lewis, Gareth R; Xia, Shirley; Spelman, Tim Denis; Hodsman, Peter; Moench, Thomas R; Humberstone, Andrew J; Paull, Jeremy RA; Tachedjian, Gilda.
In: PLoS ONE, Vol. 6, No. 9, e24095, 2011.Research output: Contribution to journal › Article › Research › peer-review
TY - JOUR
T1 - SPL7013 Gel (VivaGel) retains potent HIV-1 and HSV-2 inhibitory activity following vaginal administration in humans
AU - Price, Clare F
AU - Tyssen, David
AU - Sonza, Secondo
AU - Davie, Ashley
AU - Evans, Sonya
AU - Lewis, Gareth R
AU - Xia, Shirley
AU - Spelman, Tim Denis
AU - Hodsman, Peter
AU - Moench, Thomas R
AU - Humberstone, Andrew J
AU - Paull, Jeremy RA
AU - Tachedjian, Gilda
PY - 2011
Y1 - 2011
N2 - SPL7013 Gel (VivaGel((R))) is a microbicide in development for prevention of HIV and HSV. This clinical study assessed retention and duration of antiviral activity following vaginal administration of 3 SPL7013 Gel in healthy women. Participants received 5 single doses of product with >/=5 days between doses. A cervicovaginal fluid (CVF) sample was collected using a SoftCup pre-dose, and immediately, or 1, 3, 12 or 24 h post-dose. HIV-1 and HSV-2 antiviral activities of CVF samples were determined in cell culture assays. Antiviral activity in the presence of seminal plasma was also tested. Mass and concentration of SPL7013 in CVF samples was determined. Safety was assessed by reporting of adverse events. Statistical analysis was performed using the Wilcoxon signed-rank test with Bonferroni adjustment; p90 of initial HIV-1 and HSV-2 inhibition was maintained in 6/11 women. SPL7013 was recovered in CVF samples obtained at baseline (46 of 105 mg dose). At 3 and 24 h, 22 mg and 4 mg SPL7013, respectively, were recovered. More than 70 inhibition of HIV-1 and HSV-2 was observed if there was >0.5 mg SPL7013 in CVF samples. High levels of antiviral activity were retained in the presence of seminal plasma. VivaGel was well tolerated with no signs or symptoms of vaginal, vulvar or cervical irritation reported. Potent antiviral activity was observed against HIV-1 and HSV-2 immediately following vaginal administration of VivaGel, with activity maintained for at least 3 h post-dose. The data provide evidence of antiviral activity in a clinical setting, and suggest VivaGel could be administered up to 3 h before coitus. TRIAL REGISTRATION: The study is registered at ClinicalTrials.gov under identifier: NCT00740584.
AB - SPL7013 Gel (VivaGel((R))) is a microbicide in development for prevention of HIV and HSV. This clinical study assessed retention and duration of antiviral activity following vaginal administration of 3 SPL7013 Gel in healthy women. Participants received 5 single doses of product with >/=5 days between doses. A cervicovaginal fluid (CVF) sample was collected using a SoftCup pre-dose, and immediately, or 1, 3, 12 or 24 h post-dose. HIV-1 and HSV-2 antiviral activities of CVF samples were determined in cell culture assays. Antiviral activity in the presence of seminal plasma was also tested. Mass and concentration of SPL7013 in CVF samples was determined. Safety was assessed by reporting of adverse events. Statistical analysis was performed using the Wilcoxon signed-rank test with Bonferroni adjustment; p90 of initial HIV-1 and HSV-2 inhibition was maintained in 6/11 women. SPL7013 was recovered in CVF samples obtained at baseline (46 of 105 mg dose). At 3 and 24 h, 22 mg and 4 mg SPL7013, respectively, were recovered. More than 70 inhibition of HIV-1 and HSV-2 was observed if there was >0.5 mg SPL7013 in CVF samples. High levels of antiviral activity were retained in the presence of seminal plasma. VivaGel was well tolerated with no signs or symptoms of vaginal, vulvar or cervical irritation reported. Potent antiviral activity was observed against HIV-1 and HSV-2 immediately following vaginal administration of VivaGel, with activity maintained for at least 3 h post-dose. The data provide evidence of antiviral activity in a clinical setting, and suggest VivaGel could be administered up to 3 h before coitus. TRIAL REGISTRATION: The study is registered at ClinicalTrials.gov under identifier: NCT00740584.
UR - http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3174146/pdf/pone.0024095.pdf
U2 - 10.1371/journal.pone.0024095
DO - 10.1371/journal.pone.0024095
M3 - Article
VL - 6
JO - PLoS ONE
JF - PLoS ONE
SN - 1932-6203
IS - 9
M1 - e24095
ER -