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BioMed Central, Retrovirology, 1(12), 2015

DOI: 10.1186/s12977-015-0151-y

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HIV-1 Tat immunization restores immune homeostasis and attacks the HAART-resistant blood HIV DNA: results of a randomized phase II exploratory clinical trial

Journal article published in 2015 by Fabrizio Ensoli, Francavilla Vittorio, Mercurio S. Vito, Aurelio Cafaro, Anna Casabianca, Antonella Tripiciano, Stefania Bellino, Olimpia Longo, Orietta Picconi, Cecilia Sgadari, Sonia Moretti, Maria R. Pavone Cossut, Maria Pavone R. Cossut, Pavone Cossut R. Maria, Angela Arancio and other authors.
This paper is made freely available by the publisher.
This paper is made freely available by the publisher.

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Abstract

Abstract Background The phase II multicenter, randomized, open label, therapeutic trial (ISS T-002, Clinicaltrials.gov NCT00751595) was aimed at evaluating the immunogenicity and the safety of the biologically active HIV-1 Tat protein administered at 7.5 or 30 μg, given 3 or 5 times monthly, and at exploring immunological and virological disease biomarkers. The study duration was 48 weeks, however, vaccinees were followed until the last enrolled subject reached the 48 weeks. Reported are final data up to 144 weeks of follow-up. The ISS T-002 trial was conducted in 11 clinical centers in Italy on 168 HIV positive subjects under Highly Active Antiretroviral Therapy (HAART), anti-Tat Antibody (Ab) negative at baseline, with plasma viremia