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London, United Kingdom

Boffito M.,St Stephens Center | Fox J.,Guys and St Thomas Hospital NHS Trust | Bowman C.,Royal Hallamshire Hospital | Fisher M.,University of Sussex | And 7 more authors.
Vaccine | Year: 2013

Background: Combination antiretroviral therapy (cART) is the main therapeutic management tool for HIV/AIDS. Despite its success in controlling viral load and disease progression, cART is expensive, associated with a range of significant side effects and depends for its efficacy on the patient's life-long commitment to high levels of treatment adherence. Immunotherapeutic agents can provide potential solutions to these shortcomings. Here we describe a Phase Ib trial of HIV-v, a synthetic immunotherapy that elicits T- and B-cell effector responses against HIV infected cells. Methods: Fifty-nine cART-naive HIV-infected males aged 18-50 years with viral load of 5000-500,000. copies/ml and CD4 counts >350/μl were recruited for this multi-centre, randomised, double blind study. Volunteers received one low (250. μg) or high (500. μg) dose of HIV-v, either alone or adjuvanted (ISA-51). Safety, immunogenicity, CD4 count and viral load were monitored over 168 Days. Results: HIV-v was well tolerated and the adjuvanted formulations elicited IgG responses in up to 75% of volunteers. The high adjuvanted dose also elicited cellular responses in 45% of tested volunteers. In these responding subjects viral loads were reduced by over 1. log ( p= 0.04) compared to Placebo and non-responders. No changes in CD4 count were observed. Conclusions: HIV-v is safe and can elicit T- and B-cell responses in ART-naive HIV patients that significantly reduce viral load. Improved dosing regimens and further research on long term efficacy are required, but HIV-v appears to have potential as an immunotherapeutic anti-viral agent.Trial registered as EudraCT-2009-010593-37 (ClinicalTrials.gov Identifier: NCT01071031). © 2013 Elsevier Ltd.

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