SPL7013 Gel (VivaGel®) retains potent HIV-1 and HSV-2 inhibitory activity following vaginal administration in humans.
<h4>Unlabelled</h4>SPL7013 Gel (VivaGel(®)) 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 o...
Guardado en:
| Autores principales: | , , , , , , , , , , , , |
|---|---|
| Formato: | article |
| Lenguaje: | EN |
| Publicado: |
Public Library of Science (PLoS)
2011
|
| Materias: | |
| Acceso en línea: | https://doaj.org/article/bdfe8b68946e44cf931a6d338a6ecc77 |
| Etiquetas: |
Agregar Etiqueta
Sin Etiquetas, Sea el primero en etiquetar este registro!
|
| id |
oai:doaj.org-article:bdfe8b68946e44cf931a6d338a6ecc77 |
|---|---|
| record_format |
dspace |
| spelling |
oai:doaj.org-article:bdfe8b68946e44cf931a6d338a6ecc772021-11-04T06:08:34ZSPL7013 Gel (VivaGel®) retains potent HIV-1 and HSV-2 inhibitory activity following vaginal administration in humans.1932-620310.1371/journal.pone.0024095https://doaj.org/article/bdfe8b68946e44cf931a6d338a6ecc772011-01-01T00:00:00Zhttps://www.ncbi.nlm.nih.gov/pmc/articles/pmid/21935377/?tool=EBIhttps://doaj.org/toc/1932-6203<h4>Unlabelled</h4>SPL7013 Gel (VivaGel(®)) 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; p≤0.003 was significant. Eleven participants completed the study. Inhibition of HIV-1 and HSV-2 by pre-dose CVF samples was negligible. CVF samples obtained immediately after dosing almost completely inhibited (median, interquartile range) HIV-1 [96% (95,97)] and HSV-2 [86% (85,94)], and activity was maintained in all women at 3 h (HIV-1 [96% (95,98), p = 0.9]; HSV-2 [94% (91,97), p = 0.005]). At 24 h, >90% 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.<h4>Trial registration</h4>The study is registered at ClinicalTrials.gov under identifier: NCT00740584.Clare F PriceDavid TyssenSecondo SonzaAshley DavieSonya EvansGareth R LewisShirley XiaTim SpelmanPeter HodsmanThomas R MoenchAndrew HumberstoneJeremy R A PaullGilda TachedjianPublic Library of Science (PLoS)articleMedicineRScienceQENPLoS ONE, Vol 6, Iss 9, p e24095 (2011) |
| institution |
DOAJ |
| collection |
DOAJ |
| language |
EN |
| topic |
Medicine R Science Q |
| spellingShingle |
Medicine R Science Q Clare F Price David Tyssen Secondo Sonza Ashley Davie Sonya Evans Gareth R Lewis Shirley Xia Tim Spelman Peter Hodsman Thomas R Moench Andrew Humberstone Jeremy R A Paull Gilda Tachedjian SPL7013 Gel (VivaGel®) retains potent HIV-1 and HSV-2 inhibitory activity following vaginal administration in humans. |
| description |
<h4>Unlabelled</h4>SPL7013 Gel (VivaGel(®)) 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; p≤0.003 was significant. Eleven participants completed the study. Inhibition of HIV-1 and HSV-2 by pre-dose CVF samples was negligible. CVF samples obtained immediately after dosing almost completely inhibited (median, interquartile range) HIV-1 [96% (95,97)] and HSV-2 [86% (85,94)], and activity was maintained in all women at 3 h (HIV-1 [96% (95,98), p = 0.9]; HSV-2 [94% (91,97), p = 0.005]). At 24 h, >90% 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.<h4>Trial registration</h4>The study is registered at ClinicalTrials.gov under identifier: NCT00740584. |
| format |
article |
| author |
Clare F Price David Tyssen Secondo Sonza Ashley Davie Sonya Evans Gareth R Lewis Shirley Xia Tim Spelman Peter Hodsman Thomas R Moench Andrew Humberstone Jeremy R A Paull Gilda Tachedjian |
| author_facet |
Clare F Price David Tyssen Secondo Sonza Ashley Davie Sonya Evans Gareth R Lewis Shirley Xia Tim Spelman Peter Hodsman Thomas R Moench Andrew Humberstone Jeremy R A Paull Gilda Tachedjian |
| author_sort |
Clare F Price |
| title |
SPL7013 Gel (VivaGel®) retains potent HIV-1 and HSV-2 inhibitory activity following vaginal administration in humans. |
| title_short |
SPL7013 Gel (VivaGel®) retains potent HIV-1 and HSV-2 inhibitory activity following vaginal administration in humans. |
| title_full |
SPL7013 Gel (VivaGel®) retains potent HIV-1 and HSV-2 inhibitory activity following vaginal administration in humans. |
| title_fullStr |
SPL7013 Gel (VivaGel®) retains potent HIV-1 and HSV-2 inhibitory activity following vaginal administration in humans. |
| title_full_unstemmed |
SPL7013 Gel (VivaGel®) retains potent HIV-1 and HSV-2 inhibitory activity following vaginal administration in humans. |
| title_sort |
spl7013 gel (vivagel®) retains potent hiv-1 and hsv-2 inhibitory activity following vaginal administration in humans. |
| publisher |
Public Library of Science (PLoS) |
| publishDate |
2011 |
| url |
https://doaj.org/article/bdfe8b68946e44cf931a6d338a6ecc77 |
| work_keys_str_mv |
AT clarefprice spl7013gelvivagelretainspotenthiv1andhsv2inhibitoryactivityfollowingvaginaladministrationinhumans AT davidtyssen spl7013gelvivagelretainspotenthiv1andhsv2inhibitoryactivityfollowingvaginaladministrationinhumans AT secondosonza spl7013gelvivagelretainspotenthiv1andhsv2inhibitoryactivityfollowingvaginaladministrationinhumans AT ashleydavie spl7013gelvivagelretainspotenthiv1andhsv2inhibitoryactivityfollowingvaginaladministrationinhumans AT sonyaevans spl7013gelvivagelretainspotenthiv1andhsv2inhibitoryactivityfollowingvaginaladministrationinhumans AT garethrlewis spl7013gelvivagelretainspotenthiv1andhsv2inhibitoryactivityfollowingvaginaladministrationinhumans AT shirleyxia spl7013gelvivagelretainspotenthiv1andhsv2inhibitoryactivityfollowingvaginaladministrationinhumans AT timspelman spl7013gelvivagelretainspotenthiv1andhsv2inhibitoryactivityfollowingvaginaladministrationinhumans AT peterhodsman spl7013gelvivagelretainspotenthiv1andhsv2inhibitoryactivityfollowingvaginaladministrationinhumans AT thomasrmoench spl7013gelvivagelretainspotenthiv1andhsv2inhibitoryactivityfollowingvaginaladministrationinhumans AT andrewhumberstone spl7013gelvivagelretainspotenthiv1andhsv2inhibitoryactivityfollowingvaginaladministrationinhumans AT jeremyrapaull spl7013gelvivagelretainspotenthiv1andhsv2inhibitoryactivityfollowingvaginaladministrationinhumans AT gildatachedjian spl7013gelvivagelretainspotenthiv1andhsv2inhibitoryactivityfollowingvaginaladministrationinhumans |
| _version_ |
1718445173382316032 |