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Trial record 53 of 126 for:    HSV-2

Retention and Duration of Activity of SPL7013 (VivaGel®) After Vaginal Dosing.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00740584
Recruitment Status : Completed
First Posted : August 25, 2008
Results First Posted : August 14, 2012
Last Update Posted : October 30, 2018
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Starpharma Pty Ltd

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions HIV Infections
HSV-2 Genital Herpes
Intervention Drug: 3% SPL7013 Gel (VivaGel)
Enrollment 12
Recruitment Details 12 women recruited. Details to be provided in publication, which is in process.
Pre-assignment Details Open label study, no assignment.
Arm/Group Title Open Label, Only Arm
Hide Arm/Group Description 3%w/w SPL7013 vaginal gel (VivaGel)
Period Title: Overall Study
Started 12
Completed 11
Not Completed 1
Reason Not Completed
Withdrawal by Subject             1
Arm/Group Title Open Label, Only Arm
Hide Arm/Group Description 3%w/w SPL7013 vaginal gel (VivaGel)
Overall Number of Baseline Participants 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
<=18 years
0
   0.0%
Between 18 and 65 years
12
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
Female
12
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Australia Number Analyzed 12 participants
12
1.Primary Outcome
Title HIV Antiviral Activity of Each of the Cervico-vaginal Samples (Samples Taken From the Vagina Using the Softcup)
Hide Description

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.

Time Frame at 3 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Open Label Active
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 11
Median (Inter-Quartile Range)
Unit of Measure: percent anti-viral activity
96
(95 to 98)
2.Secondary Outcome
Title Number of Participants With Adverse Experiences
Hide Description Number of participants with any untoward medical occurrence in a subject administered the Investigational Product, irrespective of any perceived causality to that study product
Time Frame Approximately 13 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All Enrolled
Arm/Group Title Open Label, Only Arm
Hide Arm/Group Description:

3%w/w SPL7013 vaginal gel (VivaGel)

3% SPL7013 Gel (VivaGel): A single application of VivaGel applied to the vagina on five separate occasions, each occasion separated by a minimum of 5 days.

Overall Number of Participants Analyzed 12
Measure Type: Count of Participants
Unit of Measure: Participants
7
  58.3%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Open Label, Only Arm
Hide Arm/Group Description 3%w/w SPL7013 vaginal gel (VivaGel)
All-Cause Mortality
Open Label, Only Arm
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Open Label, Only Arm
Affected / at Risk (%) # Events
Total   0/12 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Open Label, Only Arm
Affected / at Risk (%) # Events
Total   3/12 (25.00%)    
Reproductive system and breast disorders   
Related Genitourinary AEs *  3/12 (25.00%)  3
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
No disclosure without SPL consent.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Development Manger
Organization: Starpharma Pty Ltd
Phone: +61 3 9532 2700
EMail: clare.price@starpharma.com
Layout table for additonal information
Responsible Party: Starpharma Pty Ltd
ClinicalTrials.gov Identifier: NCT00740584     History of Changes
Other Study ID Numbers: SPL7013-003
NIH contract HHSN266200500042C
DAIDS ES number 10730
First Submitted: August 21, 2008
First Posted: August 25, 2008
Results First Submitted: April 3, 2012
Results First Posted: August 14, 2012
Last Update Posted: October 30, 2018