Observational Study for the Extended Follow-up of the Patients Enrolled in the Therapeutic Clinical Trial ISS T-002

Barbara Ensoli, MD, PhD93 enrolled

Overview

An observational study to prospectively follow-up the patients enrolled in the ISS T-002 clinical trial up to 132 weeks. The primary endpoint of this study is to evaluate the persistence, in term of frequency, magnitude and quality, of the anti-Tat humoral and cellular immune response in the HIV-1 infected individuals who participated to the ISS T-002 and who have received at least 3 immunizations. The secondary endpoint is to define and validate novel laboratory tests for future efficacy clinical trials.

Study Type

OBSERVATIONAL

Enrollment

Conditions

HIV Infection

Interventions

No interventionOTHER

No intervention is foreseen in this Observational Study

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Previous participation in the ISS T-002 trial, having received at least 3 immunizations; * A follow-up of at least 48 weeks during the ISS T-002 study; * Availability to participate in the extended follow-up study; * Signed informed consent. Exclusion Criteria: * The absence of any of the above criteria will exclude the subjects from the study.

Locations (8)

Divisione di Malattie Infettive Azienda Ospedaliera S. Gerardo

Monza, MB, Italy

Divisione Malattie Infettive - AO Ospedale Policlinico Consorziale

Bari, Italy

Ambulatorio Malattie Infettive - AO Universitaria

Ferrara, Italy

Outcomes

Primary Outcomes

anti-Tat humoral immune response

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.

Time frame: Every 3 months, up to 2.5 years

Secondary Outcomes

Testing of the additional Immunological parameters detailed below as a second line testing

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.

Time frame: Every 3 months, up to 2.5 years

Testing of virological parameters detailed below, as a second line testing

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.

Time frame: Every 3 months, up to 2.5 years

Data from ClinicalTrials.gov

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