The present study is designed as a prospective observational study directed at evaluating the frequency, magnitude, quality and persistence (primary endpoint) of the anti-Tat immune response in highly active antiretroviral therapy (HAART)-receiving HIV-1 infected individuals, and to prospectively evaluate the immunological, virological and clinical outcome of anti-Tat positive versus anti-Tat negative subjects under successful HAART (secondary endpoint), in order to determine the impact of anti-Tat immunity on HIV disease progression as well as the potential use of anti-Tat immune response assessment for the clinical and therapeutic management of HAART-treated infected patients. This survey provided important information for the design, planning and conduction of future therapeutic vaccine trials based on the HIV-1 Tat protein in HAART-treated patients.
Study Type
OBSERVATIONAL
Enrollment
142
S.M. Goretti Hospital
Latina, Rome, Italy
General Hospital of Bari
Bari, Italy
Spedali Civili di Brescia
Brescia, Italy
General Hospital-University of Ferrara
Ferrara, Italy
A.M. Annunziata Hospital
Florence, Italy
L. Sacco Hospital
Milan, Italy
San Raffaele Hospital
Milan, Italy
General Hospital-University of Modena
Modena, Italy
San Gallicano Hospital
Rome, Italy
Amedeo di Savoia Hospital
Torino, Italy
Assessment of anti-Tat antibodies in sera of subjects, and of the proliferative response (CFSE) and the production of γIFN, IL-4 and IL-2 (Elispot) by peripheral blood mononuclear cells (PBMC) in response to Tat.
The decline of CD4+ T cell counts, the increase of HIV plasma viral load or the occurrence of AIDS-defining events were assessed to determine progression to disease.
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