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Research Article

VS411 Reduced Immune Activation and HIV-1 RNA Levels in 28 Days: Randomized Proof-of-Concept Study for AntiViral-HyperActivation Limiting Therapeutics

  • Franco Lori mail,

    info@virostatics.it

    Affiliation: ViroStatics srl, Alghero, Italy

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  • Davide De Forni,

    Affiliation: ViroStatics srl, Alghero, Italy

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  • Elly Katabira,

    Affiliation: Makerere Medical School, Kampala, Uganda

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  • Denis Baev,

    Affiliation: ViroStatics srl, Alghero, Italy

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  • Renato Maserati,

    Affiliation: Infectious Diseases Unit, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Policlinico San Matteo, Pavia, Italy

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  • Sandra A. Calarota,

    Affiliation: ViroStatics srl, Alghero, Italy

    Current address: Virology and Microbiology Department of the Fondazione IRCCS Policlinico San Matteo, Pavia, Italy

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  • Pedro Cahn,

    Affiliation: Fundación Huesped, Buenos Aires, Argentina

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  • Marco Testori,

    Affiliation: ViroStatics srl, Alghero, Italy

    Current address: Bavarian Nordic GmbH, Martinsried, BSL Bioservice Scientific Laboratories GmbH, Munich, Germany

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  • Aza Rakhmanova,

    Affiliation: Department of Infectious Diseases, St. Petersburg Health Department, St. Petersburg, Russia

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  • Michael R. Stevens

    Affiliation: ViroStatics srl, Princeton, New Jersey, United States of America

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  • Published: October 19, 2012
  • DOI: 10.1371/journal.pone.0047485

About the Authors

Franco Lori, Davide De Forni, Denis Baev, Sandra A. Calarota, Marco Testori
ViroStatics srl, Alghero, Italy
Elly Katabira
Makerere Medical School, Kampala, Uganda
Renato Maserati
Infectious Diseases Unit, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Policlinico San Matteo, Pavia, Italy
Pedro Cahn
Fundación Huesped, Buenos Aires, Argentina
Aza Rakhmanova
Department of Infectious Diseases, St. Petersburg Health Department, St. Petersburg, Russia
Michael R. Stevens
ViroStatics srl, Princeton, New Jersey, United States of America

Corresponding Author

Email: info@virostatics.it

Competing Interests

The study was sponsored by commercial funder ViroStatics srl; FL, DDF and MRS are currently consultants to, employees of and/or hold shares or options in ViroStatics srl. FL is the CEO and President of the Board of ViroStatics srl. Although VS411 is not being commercially developed, there are several patents to protect the VS411 combination product and technology in which FL is an inventor, as follows: “Method of Inhibiting Human Immunodeficiency Virus by combined use of Hydroxyurea, a nucleoside analog, and a protease inhibitor”, USSN 08/812,515 filed Mar 7, 1997. Issued as USPN 6,114,312 on Sep 5, 2000. HU + ddI + protease inhibitor (“Triple Combination Continuation”) Inventors: Julianna Lisziewicz; FL. USSN 09/048,886, WO/1999/048504 filed Mar 26, 1998. Issued as USPN 6,251,874 on June 26, 2001: “Method of Inhibiting Human Immunodeficiency Virus using Hydroxyurea and a Reverse Transcriptase Inhibitor in vivo”. Issued. Method, HU+ddI+Indinavir OR HU + ddI, depending on viral load (“Double or Triple”) Inventors: Julianna Lisziewicz; FL. There are no further patents, products in development or marketed products to declare. This does not alter the authors’ adherence to all the PLOS ONE policies on sharing data and materials.

Author Contributions

Conceived and designed the experiments: FL MRS DDF SAC. Performed the experiments: DDF DB SAC MT. Analyzed the data: FL DDF DB SAC MRS. Wrote the paper: FL DDF MRS. Study Investigators: EK RM PC AR.