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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Starpharma Pty Ltd
ClinicalTrials.gov Identifier:
NCT00740584
First received: August 21, 2008
Last updated: July 5, 2012
Last verified: July 2012
Results First Received: April 3, 2012  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: HIV Infections
HSV-2 Genital Herpes
Intervention: Drug: 3% SPL7013 Gel (VivaGel)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
12 women recruited. Details to be provided in publication, which is in process.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Open label study, no assignment.

Reporting Groups
  Description
Open Label, Only Arm 3%w/w SPL7013 vaginal gel (VivaGel)

Participant Flow:   Overall Study
    Open Label, Only Arm  
STARTED     12  
COMPLETED     11  
NOT COMPLETED     1  
Withdrawal by Subject                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Open Label, Only Arm 3%w/w SPL7013 vaginal gel (VivaGel)

Baseline Measures
    Open Label, Only Arm  
Number of Participants  
[units: participants]
  12  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     12  
>=65 years     0  
Gender  
[units: participants]
 
Female     12  
Male     0  
Region of Enrollment  
[units: participants]
 
Australia     12  



  Outcome Measures

1.  Primary:   HIV Antiviral Activity of Each of the Cervico-vaginal Samples (Samples Taken From the Vagina Using the Softcup)   [ Time Frame: at 3 hours ]

2.  Secondary:   Incidence of Adverse Experiences   [ Time Frame: Approximately 13 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Clinical Development Manger
Organization: Starpharma Pty Ltd
phone: +61 3 9532 2700
e-mail: clare.price@starpharma.com


Publications:

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
Study First Received: August 21, 2008
Results First Received: April 3, 2012
Last Updated: July 5, 2012
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration