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| ID | Type | Description | Link |
|---|---|---|---|
| NIH contract HHSN266200500042C | |||
| DAIDS ES number 10730 |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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To assess the retention and anti-viral activity (human immunodeficiency virus (HIV) and herpes simplex virus 2 (genital herpes, HSV-2) of SPL7013 in cervicovaginal samples taken up to 24 hours after administration of 3% SPL7013 in the vagina. There is no hypothesis for this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open Label, only arm | Experimental | 3%w/w SPL7013 vaginal gel (VivaGel) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3% SPL7013 Gel (VivaGel) | Drug | A single application of VivaGel applied to the vagina on five separate occasions, each occasion separated by a minimum of 5 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| HIV Antiviral Activity of Each of the Cervico-vaginal Samples (Samples Taken From the Vagina Using the Softcup) | The HIV antiviral activity is the ability of each sample taken from the vagina (cervico-vaginal (CV) sample) to inhibit HIV virus from infecting a specific cell culture. The inhibition of HIV in the presence of the CV sample is compared to the inhibition of HIV in the cell culture with no CV sample added. This allows an assessment of the affect that the CV sample has. | at 3 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Experiences | Number of participants with any untoward medical occurrence in a subject administered the Investigational Product, irrespective of any perceived causality to that study product | Approximately 13 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nucleus Network | Melbourne | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21935377 | Background | Price CF, Tyssen D, Sonza S, Davie A, Evans S, Lewis GR, Xia S, Spelman T, Hodsman P, Moench TR, Humberstone A, Paull JR, Tachedjian G. SPL7013 Gel (VivaGel(R)) retains potent HIV-1 and HSV-2 inhibitory activity following vaginal administration in humans. PLoS One. 2011;6(9):e24095. doi: 10.1371/journal.pone.0024095. Epub 2011 Sep 15. |
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Open label study, no assignment.
12 women recruited. Details to be provided in publication, which is in process.
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| ID | Title | Description |
|---|---|---|
| FG000 | Open Label, Only Arm | 3%w/w SPL7013 vaginal gel (VivaGel) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Open Label, Only Arm | 3%w/w SPL7013 vaginal gel (VivaGel) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | HIV Antiviral Activity of Each of the Cervico-vaginal Samples (Samples Taken From the Vagina Using the Softcup) | The HIV antiviral activity is the ability of each sample taken from the vagina (cervico-vaginal (CV) sample) to inhibit HIV virus from infecting a specific cell culture. The inhibition of HIV in the presence of the CV sample is compared to the inhibition of HIV in the cell culture with no CV sample added. This allows an assessment of the affect that the CV sample has. | Posted | Median | Inter-Quartile Range | percent anti-viral activity | at 3 hours |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Open Label, Only Arm | 3%w/w SPL7013 vaginal gel (VivaGel) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Related Genitourinary AEs | Reproductive system and breast disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Development Manger | Starpharma Pty Ltd | +61 3 9532 2700 | clare.price@starpharma.com |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| ID | Term |
|---|---|
| C480351 | astodrimer |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Number of Participants With Adverse Experiences | Number of participants with any untoward medical occurrence in a subject administered the Investigational Product, irrespective of any perceived causality to that study product | All Enrolled | Posted | Count of Participants | Participants | Approximately 13 weeks |
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|
|
| 0 |
| 12 |
| 3 |
| 12 |
No disclosure without SPL consent.
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |