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MTN-004

Details
Protocol Title: 
Phase 1 Study of the Safety and Acceptability of 3% w/w SPL7013 Gel (VivaGel®) Applied Vaginally in Sexually Active Young Women
DAIDS Protocol ID: 
10492
Status: 
Participants off Study and Primary Analysis Completed

Protocol Chair(s)

Ian McGowan [1] (Protocol Chair)

Email Groups

MTN-004 Acceptability and Adherence Task Group [2]
MTN-004 Accrual [3]
MTN-004 Laboratory Group [4]
MTN-004 Protocol Deviations Reporting Team [5]
MTN-004 Protocol Safety Review Team [6]
MTN-004 Protocol Team [7]
MTN-004 Publication Committee [8]
MTN-004 Study Coordinators [9]
MTN-004 Study Management Team [10]
MTN-004 Study Monitoring Committee [11]
MTN-004 Web Troubleshooting [12]
Sites
Pitt CRS [13]
Countries
United States [14]
Description
Safety and Acceptability of VivaGel® in Sexually Active Women

MTN-004 is a Phase I study evaluating the safety, acceptability and ease of use of the microbicide candidate VivaGel™ (SPL7013 Gel) in sexually active, HIV-negative women ages 18 to 24. The study enrolled 61 women at three study sites.  Results of the trial will help researchers determine if the product should be considered for further testing in a larger study, and eventually, in a trial to evaluate if use of the gel can prevent sexual transmission of HIV in young women. The study was conducted in collaboration with the Adolescent Medicine Trials Network for HIV/AIDS Interventions of the U.S. Eunice Kennedy Shriver National Institute of Child Health and Human Development.  Results are expected in late May 2010.

Other Study Info

Sponsors:

Division of AIDS, US National Institute of Allergy and Infectious Diseases

US Eunice Kennedy Shriver National Institute of Child Health and Human Development

US National Institutes of Health

Co-Sponsor:

Starpharma Pty Ltd

Study design:

Phase 1, two arm, two site, randomized, double blind, placebo-controlled trial comparing VivaGel® Gel, VivaGel® placebo, or HEC placebo applied vaginally twice daily for 14 days

Printer-friendly version [15]
Source URL: http://www.mtnstopshiv.org/studies/64

Links:
[1] http://www.mtnstopshiv.org/users/imcgowan
[2] http://www.mtnstopshiv.org/people/emailgroups/36
[3] http://www.mtnstopshiv.org/people/emailgroups/49
[4] http://www.mtnstopshiv.org/people/emailgroups/37
[5] http://www.mtnstopshiv.org/people/emailgroups/35
[6] http://www.mtnstopshiv.org/people/emailgroups/32
[7] http://www.mtnstopshiv.org/people/emailgroups/6
[8] http://www.mtnstopshiv.org/people/emailgroups/135
[9] http://www.mtnstopshiv.org/people/emailgroups/34
[10] http://www.mtnstopshiv.org/people/emailgroups/33
[11] http://www.mtnstopshiv.org/people/emailgroups/38
[12] http://www.mtnstopshiv.org/people/emailgroups/46
[13] http://www.mtnstopshiv.org/sites/51
[14] http://www.mtnstopshiv.org/countries/united-states
[15] http://www.mtnstopshiv.org/print/64

Media Contacts:

Lisa Rossi -- Office: +1 412 641-8940 -- Mobile: +1 412 916-3315 -- Email: rossil@upmc.edu

Clare Collins -- Office: +1 412 641-7299 -- Mobile: +1 412 770-8643 -- Email: collcx@upmc.edu