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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Istituto Superiore di Sanità
Sponsor:
Information provided by (Responsible Party):
Barbara Ensoli, MD, Istituto Superiore di Sanità
ClinicalTrials.gov Identifier:
NCT02118168
First received: April 15, 2014
Last updated: August 8, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
HIV Infection
Other: No intervention

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: OBSERVATIONAL STUDY FOR THE EXTENDED FOLLOW-UP OF THE PATIENTS ENROLLED IN THE PHASE II THERAPEUTIC CLINICAL TRIAL ISS T-002

Resource links provided by NLM:


Further study details as provided by Istituto Superiore di Sanità:

Primary Outcome Measures:
  • anti-Tat humoral immune response [ Time Frame: Every 3 months, up to 2.5 years ] [ Designated as safety issue: No ]
    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:
  • Testing of the additional Immunological parameters detailed below as a second line testing [ Time Frame: Every 3 months, up to 2.5 years ] [ Designated as safety issue: No ]
    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/in vitro 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; Bcell cloning; Characterization of clono-specific antibodies; Serum/plasma determination of sCD4

  • Testing of virological parameters detalied below, as a second line testing [ Time Frame: Every 3 months, up to 2.5 years ] [ Designated as safety issue: No ]
    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

blood samples


Estimated Enrollment: 168
Study Start Date: September 2013
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 forseen in this Observational Study

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02118168

Contacts
Contact: Barbara Ensoli, MD, PHD +39 06 4990 ext 3209 barbara.ensoli@iss.it

Locations
Italy
Divisione di Malattie Infettive Azienda Ospedaliera S. Gerardo Active, not recruiting
Monza, MB, Italy, 20052
Divisione Malattie Infettive - AO Ospedale Policlinico Consorziale Recruiting
Bari, Italy, 70124
Contact: Gioacchino Angarano, MD    + 39 080 5593 ext 120    gioacchino.angarano@uniba.it   
Ambulatorio Malattie Infettive - AO Universitaria Active, not recruiting
Ferrara, Italy, 44124
Unità Operativa di Malattie Infettive - Ospedale S.M. Annunziata Recruiting
Firenze, Italy, 50012
Contact: Francesco Mazzotta, MD    + 39 055 2496 ext 233    francesco.mazzotta@asf.toscana.it   
U. O. di Malattie Infettive Centro di Ricerca e Cura Patologie HIV correlate - Ospedale San Raffaele Recruiting
Milano, Italy, 20124
Contact: Adriano Lazzarin, MD    +39 02-26437 ext 939    lazzarin.adriano@hsr.it   
Istituto di Malattie Infettive e Tropicali - AO Luigi Sacco Recruiting
Milano, Italy, 20152
Contact: Massimo Galli, MD    +39 02 39042 ext 451    massimo.galli@unimi.it   
Divisione di Malattie Infettive - AO Universitaria Policlinico Recruiting
Modena, Italy, 41100
Contact: Cristina Mussini, MD    +39 059 4222 ext 827    crimus@unimore.it   
U.O.C. Dermatologia Infettiva ed Allergologica - IFO San Gallicano Recruiting
Roma, Italy, 00144
Contact: Alessandra Latini, MD    +39 06-5266 ext 2804    a.latini@ifo.it   
Sponsors and Collaborators
Barbara Ensoli, MD
Investigators
Study Director: Barbara Ensoli, MD, PHD Istituto Superiore di Sanità
  More Information

Additional Information:
Publications:

Responsible Party: Barbara Ensoli, MD, MD, Istituto Superiore di Sanità
ClinicalTrials.gov Identifier: NCT02118168     History of Changes
Other Study ID Numbers: ISS T-002 EF-UP
Study First Received: April 15, 2014
Last Updated: August 8, 2014
Health Authority: Italy: AIFA

Keywords provided by Istituto Superiore di Sanità:
HIV
HAART
Tat Protein

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on September 30, 2014