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, Double-blind, Randomized
Arms and Assigned Interventions
Descriptionapplied vaginally twice daily for 14 days
Mode of DeliveryGel
ARMsExperimental
Descriptionapplied vaginally twice daily for 14 days
Mode of DeliveryGel
ARMsPlacebo Comparator
Results: Phase 1 randomized trial of the vaginal safety and acceptability of SPL7013 gel
Official Code: MTN 004
Trial Sponsors: ATN, MTN, NIAID, NIH, US Eunice Kennedy Shriver National Institute of Child Health and Human Development
Start Date
End Date
May 8, 2014
May 8, 2014
Enrollment:61
Age range: 18 Years ↔ 24 Years
Population:Cisgender Women