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MTN 004

Status
Completed
Phase
I
Principal Investigator(s)
Ian McGowan
Objective

Safety and acceptibility of SPL7013 (VivaGel) gel in sexually active women. 

Results: No serious adverse events or withdrawals due to adverse events were reported. Genitourinary symptoms were reported as follows: VivaGel (n = 17/22; 77.3%), VivaGel placebo (n = 14/21; 66.7%), and HEC (n = eight of 18; 44.4%; not significant, P = 0.1). 

Prevention Option(s)
Microbicides
Study Design
Controlled
Randomized
Double-blind
Arms and Assigned Interventions
Description
applied vaginally twice daily for 14 days
Mode of Delivery
Gel
Products
VivaGel™
ARMs
Experimental
Description
applied vaginally twice daily for 14 days
Mode of Delivery
Gel
Products
HEC gel
ARMs
Placebo Comparator
Results
Phase 1 randomized trial of the vaginal safety and acceptability of SPL7013 gel (VivaGel) in sexually active young women (MTN-004)
Official Code
MTN 004
Trial Sponsors
NIAID, US Eunice Kennedy Shriver National Institute of Child Health and Human Development, NIH, MTN, ATN
Product Developers
Starpharma Pty Ltd
May 2014
May 2014
Enrollment
61
18
Years
24
Years
Population
Women
Sites

University of Pittsburgh CRS

Pittsburgh, Pennsylvania
United States of America

University of South Florida

Tampa, Florida
United States of America

University of Puerto Rico Medical Sciences Campus

San Juan
Puerto Rico