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VivaGel™ (SPL7013 Gel): A candidate dendrimer – microbicide for the prevention of HIV and HSV infection

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TLDR
VivaGel™ appears to be well tolerated in both animals and humans and its active ingredient, SPL7013, a dendrimer that was designed specifically with HIV and HSV antiviral activity and human safety in mind.
Abstract
Microbicides are compounds that applied vaginally or rectally, protect the user from sexually transmitted infections. Although no commercial product is yet available, many candidates are under development. A leading candidate, VivaGel (SPL7013 Gel) is the product of nanotechnology. The active ingredient is SPL7013, a dendrimer that was designed specifically with HIV and HSV antiviral activity and human safety in mind. SPL7013 has demonstrated efficacy against human immunodeficiency virus and herpes simplex virus in in vitro and animal models. VivaGel appears to be well tolerated in both animals and humans. This review summarizes the studies of VivaGel and its active ingredient, SPL7013.

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References
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Dendrimers as Drugs: Discovery and Preclinical and Clinical Development of Dendrimer-Based Microbicides for HIV and STI Prevention

TL;DR: This contextual review describes how dendrimers offer a unique platform for exploring chemical diversity on the nanoscale and how the production of d endrimer libraries covering a diverse array of macromolecular structures can be used in drug discovery and development.
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SPL7013 gel as a topical microbicide for prevention of vaginal transmission of SHIV89.6P in macaques.

TL;DR: Results showed that 3-5% w/w SPL7013 gels were effective in blocking vaginal transmission of SHIV in macaques after single gel application followed by single virus challenge, and suggest that SPL 7013 gel may be a promising anti-HIV microbicide formulation for further evaluation.
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In Vitro Comparison of Topical Microbicides for Prevention of Human Immunodeficiency Virus Type 1 Transmission

TL;DR: A standardized protocol was used to compare cellular toxicities and anti-human immunodeficiency virus type 1 (HIV-1) activities of candidate microbicides formulated for human use and indicates that this protocol may be useful for predicting toxicity in vivo.
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Considerations and development of topical microbicides to inhibit the sexual transmission of HIV.

TL;DR: A review will assess the development of molecules or formulations that modify the genital environment in the context of cervicovaginal defences and the clinical failure of nonoxynol-9.
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Evaluations of Unformulated and Formulated Dendrimer-Based Microbicide Candidates in Mouse and Guinea Pig Models of Genital Herpes

TL;DR: Three new dendrimer products developed to provide stable and cost-efficient microbicides were initially evaluated in vitro for anti-herpes simplex virus activity and then in vivo by using a mouse model of genital herpes to define the dose and duration of protection.
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