A Phase II randomized, open label, immunogenicity and safety trial of the vaccine based on the recombinant biologically active HIV-1 Tat protein in anti-Tat negative HIV-1 infected HAART-treated adult subjects. - ISS T-002

ISTITUTO SUPERIORE DI SANITA'0 个研究点开始时间: 2008年5月21日最近更新: 2013年1月7日

试验速览

暂无简介。

•1)Age 18-55 years;
•2)Anti-Tat antibody negative subjects;
•3)HIV-1 infected subjects under successful HAART treatment (with chronic suppressed HIV-1 infection) with CD4+ T cell counts > 400 cells/l determined by 2 separate evaluations within the 3 weeks pre-study screening period (at day -21 and then between day -14 and -7);
•4)HIV plasma viremia <50 copies/ml in the last 6 months prior to the screening and without a history of virological rebound;
•5)Subjects with pre-HAART CD4 nadir > 250 cells/l;
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1)History of AIDS-related opportunistic or neoplastic disease;
•2)History of encephalopathy, neuropathy, or unstable CNS pathology (HIV or non-HIV related);
•3)History of non-HIV related neoplastic diseases, autoimmune diseases, severe and/or persistent angina or cardiac arithymias, or, severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, thyroid gland or renal disease);
•4)Any evidence, as judged by the investigator, of unstable cardio-vascular disease (e.g. unstable hypertensive disease needing modification or introduction of an anti-hypertensive treatment);
•5)Laboratory findings exceeding the normal range adopted by each clinical site laboratory for haematology and biochemistry assessments will make undesirable for the subject the participation to the study. In particular, subjects presenting AST/ALT > 3 x the upper limit of normal will be excluded, as well as AST/ALT > 5 x the upper limit of normal in case of subjects having co-infections HIV/HCV related);

发起方