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

• Conditions: HIV-1 infected subjects; MedDRA version: 9.1Level: LLTClassification code 10020161Term: HIV infection

• Registration Number: EUCTR2007-007200-16-IT
• Lead Sponsor: ISTITUTO SUPERIORE DI SANITA'

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05-21
• Last Update Posted: 7 January 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

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);

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this study is to demonstrate that the Tat vaccine is immunogenic in HIV-1 infected, anti-Tat antibody negative subjects treated with antiretroviral therapy;Secondary Objective: The secondary objective is to monitor the safety of the Tat vaccine in immunized subjects.;Primary end point(s): to demonstrate that the Tat vaccine is immunogenic in HIV-1 infected