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SPL7013 Gel (VivaGel(TM)), a topical microbicide in development for prevention of HIV and genital herpes, shown to be well tolerated and comparable with placebo after seven days administration in healthy males.
Presented by Jeremy Paull, .
Paull J.1, Chen M.2, Millwood I.3, Wand H.3, Poynten M.3, Law M.3, Kaldor J.3, Wesselingh S.4, Price C.1, Heery G.1, Clark L.1, Fairley C.2, Funded with Federal funds from the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, Contract No. HHSN266200500042C
1Starpharma Pty Ltd, Melbourne, Australia, 2Melbourne Sexual Health Centre and School of Population Health, University of Melbourne, Melbourne, Australia, 3National Centre in HIV Epidemiology and Clinical Research, University of New South Wales, Sydney, Australia, 4Burnet Institute, Melbourne, Australia
Objectives: The objective of this single centre, double-blind, randomized, placebo-controlled study was to determine the safety of a topical vaginal microbicide, SPL7013 Gel (VivaGel™), in development for the prevention of HIV and genital herpes, when administered to the penis of healthy males.
Methods: The primary outcome of the study was symptoms and signs of genital toxicity. Secondary safety outcomes included systemic toxicity, and systemic absorption of SPL7013. Thirty-six healthy males (18 circumcised, 18 uncircumcised), were randomised and treated with 3% SPL7013 Gel (N=24) or placebo gel (N=12). Participants applied gel to the penis once daily for 7 days. Genital toxicity was determined by interview, diary evaluation, and genital examination. Systemic toxicity was determined by non-genital adverse events (AEs) and laboratory assessments. Systemic absorption was determined via plasma concentration of SPL7013.
Results: The frequency of genital AEs was not significantly different between SPL7013 Gel and placebo groups. All genital AEs were mild (grade 1), and all but one was self-limiting. Of the 24 SPL7013 Gel recipients, 8 (33%) reported 12 genital AEs (10 reported by 6 subjects (25%) were considered related to study product). Of the 12 placebo recipients, 4 (33%) reported 5 genital AEs (all considered related). The most common genital AEs were: genital pruritis (3 (33%) SPL7013 Gel, 1 (8%) placebo); and application site (penile) erythema (1 (4%) SPL7013 Gel, 3 (25%) placebo). Analysis of genital and non-genital AEs, laboratory parameters and vital signs indicated no safety or tolerability issues for either SPL7013 Gel or placebo groups, irrespective of circumcision status. There were no grade 3, grade 4, or Serious AEs. There was no detectable absorption of SPL7013.
Conclusions: 3% SPL7013 Gel was safe and well tolerated, and comparable with placebo, when administered to the penis of healthy, circumcised and uncircumcised males once daily for 7 days, with no evidence of systemic absorption.
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