Observational Study for the Extended Follow-up of the Patients Enrolled in the Therapeutic Clinical Trial ISS T-002 (ISST-002 EF-UP)

August 21, 2017 updated by: Barbara Ensoli, MD, PhD

OBSERVATIONAL STUDY FOR THE EXTENDED FOLLOW-UP OF THE PATIENTS ENROLLED IN THE PHASE II THERAPEUTIC CLINICAL TRIAL ISS T-002

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

93

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bari, Italy, 70124
        • Divisione Malattie Infettive - AO Ospedale Policlinico Consorziale
      • Ferrara, Italy, 44124
        • Ambulatorio Malattie Infettive - AO Universitaria
      • Firenze, Italy, 50012
        • Unità Operativa di Malattie Infettive - Ospedale S.M. Annunziata
      • Milano, Italy, 20124
        • U. O. di Malattie Infettive Centro di Ricerca e Cura Patologie HIV correlate - Ospedale San Raffaele
      • Milano, Italy, 20152
        • Istituto di Malattie Infettive e Tropicali - AO Luigi Sacco
      • Modena, Italy, 41100
        • Divisione di Malattie Infettive - AO Universitaria Policlinico
      • Roma, Italy, 00144
        • U.O.C. Dermatologia Infettiva ed Allergologica - IFO San Gallicano
    • MB
      • Monza, MB, Italy, 20052
        • Divisione di Malattie Infettive Azienda Ospedaliera S. Gerardo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

HAART-treated patients who participated to the therapeutic phase II trial of the Tat vaccine "ISS T-002" and received at least 3 immunizations and reached 48-weeks of follow-up.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
No treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Every 3 months, up to 2.5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Every 3 months, up to 2.5 years
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.
Every 3 months, up to 2.5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Barbara Ensoli, MD, PhD

Investigators

  • Study Director: Barbara Ensoli, MD, PHD, Istituto Superiore di Sanità

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (ACTUAL)

July 1, 2016

Study Completion (ACTUAL)

December 1, 2016

Study Registration Dates

First Submitted

April 15, 2014

First Submitted That Met QC Criteria

April 16, 2014

First Posted (ESTIMATE)

April 21, 2014

Study Record Updates

Last Update Posted (ACTUAL)

August 22, 2017

Last Update Submitted That Met QC Criteria

August 21, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ISS T-002 EF-UP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on HIV Infection

Clinical Trials on No intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Austria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe