Abstract
ObjectiveTo assess the safety of VivaGel® used vaginally twice daily for 14 days among healthy, sexually-abstinent women, aged 18–24 years in the USA and Kenya.DesignRandomized placebo controlled trial.MethodsParticipants were randomized 2∶1, VivaGel to placebo. Safety was assessed by comparing genitourinary (GU) adverse events (AEs), colposcopy findings, vaginal lactobacilli and laboratory abnormalities by arm.ResultsFifty-four women were enrolled; 35 in the VivaGel arm and 19 in the placebo arm. Twenty-six (74%) and 10 (53%) women reported taking all doses of VivaGel and placebo, respectively. No grade 3 or 4 AEs, or serious AEs occurred. Twenty-five (71%) participants in the VivaGel arm compared to 10 (53%) participants in the placebo arm had at least one grade 1 or 2 GU AE associated with product use (RR = 1.4, 95% CI 0.8-2.2). All seven grade 2 GU AEs associated with product use occurred among four women in the VivaGel arm. Vulvar and cervical erythema, cervical lesions, symptomatic BV, urinary frequency and metrorrhagia were more common in the VivaGel arm than the placebo arm. Twenty-nine (83%) participants in the VivaGel arm had a colposcopic finding compared to 10 (53%) participants in the placebo arm (RR = 1.6, 95%CI = 1.0-2.5). Two women in the VivaGel arm prematurely discontinued product use themselves due to a reported GU AE. Persistence of H2O2-producing and non-producing lactobacilli did not differ by study arm.ConclusionsGU AEs and colposcopic findings consistent with mild epithelial irritation and inflammation occurred more commonly among women in the VivaGel arm.Trial RegistrationClinicalTrials.gov NCT003311032
Highlights
In sub-Saharan Africa, 59% of people living with HIV are women [1], and in Kenya girls age 15–24 are six times more likely to be HIV-infected than their male age-mates (3% prevalence for girls versus,0.5% for boys) [2]
Young women are at a high risk of acquiring genital herpes caused by herpes simplex virus type 2 (HSV-2) and other sexually transmitted infections (STI) which promote the transmission of HIV [3]
Safety was assessed by comparing the incidence of adverse events (AE), including genitourinary (GU) clinical signs and symptoms, colposcopic findings of the genital tract, renal and liver function, systemic absorption of SPL7013, and vaginal microflora among participants randomized to VivaGelH (3% w/w SPL7013 in a Carbopol-based aqueous formulation) and those randomized to placebo (Carbopol-based aqueous formulation with 0% w/w SPL7013)
Summary
In sub-Saharan Africa, 59% of people living with HIV are women [1], and in Kenya girls age 15–24 are six times more likely to be HIV-infected than their male age-mates (3% prevalence for girls versus ,0.5% for boys) [2]. A strategy that encourages delayed sexual debut, monogamy and condom use is important to control the spread of STI/HIV, but this approach requires a level of female empowerment and control in sexual relationships often lacking for young women. This widespread disparity of gender power relationships makes the development, evaluation and testing of safe and effective topical microbicides that are effective against. A previous phase 1 trial included colposcopic evaluation in 36 healthy, sexually abstinent, year old women in Australia and demonstrated safety and tolerance of 0.5% to 3% w/w SPL7013 gel when administered once daily for seven consecutive days [10]
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
