HIV-1 infected subjects MedDRA version: 9.1 Level: LLT Classification code 10020161 Term: HIV infection
Conditions
Interventions
Product Name: recombinant biologically active HIV1 Tat protein
Product Code: Tat
Pharmaceutical Form: Solution for injection
INN or Proposed INN: recombinant biologically active HIV1 Tat protein
Curr
Sponsors
ISTITUTO SUPERIORE DI SANITA'
Eligibility
Sex/Gender
All
Inclusion criteria
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 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
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);
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Italy
Outcome results
None listed