Observational Study for the Extended Follow-up of the Patients Enrolled in the Therapeutic Clinical Trial ISS T-002 (ISST-002 EF-UP)
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|ClinicalTrials.gov Identifier: NCT02118168|
Recruitment Status : Completed
First Posted : April 21, 2014
Last Update Posted : August 22, 2017
|Condition or disease||Intervention/treatment|
|HIV Infection||Other: No intervention|
|Study Type :||Observational|
|Actual Enrollment :||93 participants|
|Official Title:||OBSERVATIONAL STUDY FOR THE EXTENDED FOLLOW-UP OF THE PATIENTS ENROLLED IN THE PHASE II THERAPEUTIC CLINICAL TRIAL ISS T-002|
|Study Start Date :||September 2013|
|Actual Primary Completion Date :||July 2016|
|Actual Study Completion Date :||December 2016|
All patients that participated to the therapeutic phase II trial of the Tat vaccine "ISS T-002" and that received at least 3 immunizations and reached 48-weeks of follow-up.
Other: No intervention
No intervention is foreseen in this Observational Study
- anti-Tat humoral immune response [ Time Frame: Every 3 months, up to 2.5 years ]The primary endpoint of the study is to evaluate the persistence, in term of frequency, magnitude, and quality of the anti-Tat humoral immune response in HAART-treated patients previously immunize with Tat in the ISS T-002 phase II clinical trial.
- Testing of the additional Immunological parameters detailed below as a second line testing [ Time Frame: Every 3 months, up to 2.5 years ]The secondary endpoint of the study is to identify and validate immunological testing for future efficacy vaccine clinical trials, as follows: Lymphoproliferative response to Tat, anti-Tat γIFN, IL4 and IL2 production; In vitro neutralization of Tat activity (Tat/Env uptake); Lymphocyte subsets; Anti-Tat IgG subclasses; Epitope mapping of anti-Tat IgM and IgG; Anti-HIV regulatory and structural proteins antibodies; ADCC; Neutralization of Tat activity by rescue assay; Neutralization of primary HIV isolates; Anti-CCR5 and Anti-CD4 antibodies; Lymphoproliferative response to Env, mitogens and recall antigens In vitro γIFN, IL4 and IL2 production in response to Tat (ICS) and to Env (ICS/Elispot); B cells phenotype; Characterization of Treg cells; PBMC ICS for granzyme, perforin, cytokines and chemokines; Th1 and Th2 cytokines and chemokines; Lymphocytes spontaneous cell death; B cell cloning; Characterization of clono-specific antibodies; Serum/plasma determination of sCD4.
- Testing of virological parameters detailed below, as a second line testing [ Time Frame: Every 3 months, up to 2.5 years ]The secondary endpoint of the study is to identify and validate virological testing for future efficacy vaccine clinical trials, as follows: HIV-1 plasma viremia (viral RNA copies), HIV-1 sequencing and virus phylogenetic analysis, Genotypic resistance, Viral tropism, Anti-HBV antibodies, HBV antigens (HbsAg, HbeAg), Anti-HCV antibodies and plasma viremia, HHV-8 antibodies and plasma viremia, HIV-1 Proviral DNA copies.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02118168
|Divisione di Malattie Infettive Azienda Ospedaliera S. Gerardo|
|Monza, MB, Italy, 20052|
|Divisione Malattie Infettive - AO Ospedale Policlinico Consorziale|
|Bari, Italy, 70124|
|Ambulatorio Malattie Infettive - AO Universitaria|
|Ferrara, Italy, 44124|
|Unità Operativa di Malattie Infettive - Ospedale S.M. Annunziata|
|Firenze, Italy, 50012|
|U. O. di Malattie Infettive Centro di Ricerca e Cura Patologie HIV correlate - Ospedale San Raffaele|
|Milano, Italy, 20124|
|Istituto di Malattie Infettive e Tropicali - AO Luigi Sacco|
|Milano, Italy, 20152|
|Divisione di Malattie Infettive - AO Universitaria Policlinico|
|Modena, Italy, 41100|
|U.O.C. Dermatologia Infettiva ed Allergologica - IFO San Gallicano|
|Roma, Italy, 00144|
|Study Director:||Barbara Ensoli, MD, PHD||Istituto Superiore di Sanità|