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

Completed

• Conditions: HIV Infection
• Interventions: Other: No intervention

• Registration Number: NCT02118168
• Lead Sponsor: Barbara Ensoli, MD, PhD

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2014-04-15
• Study First Submitted QC: 2014-04-16
• Study First Posted: 2014-04-21
• Primary Completion: 2016-07
• Study Completion: 2016-12
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-21
• Last Update Posted: 2017-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 93

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
No treatment	No intervention	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.

Primary Outcome Measures

Name	Time	Method
anti-Tat humoral immune response	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.

Secondary Outcome Measures

Name	Time	Method
Testing of the additional Immunological parameters detailed below as a second line testing	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	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.

Trial Locations

Locations (8)

Divisione di Malattie Infettive Azienda Ospedaliera S. Gerardo; 🇮🇹 Monza, MB, Italy

Unità Operativa di Malattie Infettive - Ospedale S.M. Annunziata; 🇮🇹 Firenze, Italy

U. O. di Malattie Infettive Centro di Ricerca e Cura Patologie HIV correlate - Ospedale San Raffaele; 🇮🇹 Milano, Italy

Istituto di Malattie Infettive e Tropicali - AO Luigi Sacco; 🇮🇹 Milano, Italy

U.O.C. Dermatologia Infettiva ed Allergologica - IFO San Gallicano; 🇮🇹 Roma, Italy

Ambulatorio Malattie Infettive - AO Universitaria; 🇮🇹 Ferrara, Italy

Divisione di Malattie Infettive - AO Universitaria Policlinico; 🇮🇹 Modena, Italy

Divisione Malattie Infettive - AO Ospedale Policlinico Consorziale; 🇮🇹 Bari, Italy