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MTN-004 was a double-blind, placebo-controlled study investigating the safety, tolerability, and systemic absorption of 3% VivaGel® when administered vaginally twice daily for 14 consecutive days in healthy, sexually active, HIV-negative young women. This study was a collaborative effort between the MTN and the Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). Participants were to be randomized to either 3% w/w VivaGel® or VivaGel® placebo in a 1:1 ratio.

Enrollment into this study began in July 2007 and was paused in October 2007 for a review of adverse event data.  An interim blinded review of laboratory and clinical data on the seven enrolled women took place and confirmed that the study could continue. The protocol was revised and a third treatment arm was added to the study, a universal hydroxyethylcellulose (HEC)  placebo gel arm,  so that newly enrolled women would be assigned to receive either VivaGel®, VivaGel® placebo, or HEC placebo gel..  Thus, the study provides a comparison of the safety of VivaGel®, VivaGel® placebo and the HEC placebo gel in sexually active young women. Results were first presented at the Microbicides 2010 conference.

Protocol Chair(s)
McGowan, Ian (Protocol Chair)
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
Formulation
Gel
Drug
Placebo
VivaGel
Study Focus/Product Administration
Vaginal
Study Type
Behavioral
Safety
Study Phase
Phase I  
Countries
United States
Population
Women (cisgender women, non‐transgender women)
Funder(s)
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
Sponsor(s)
Starpharma Pty Ltd
Other Study Info

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