Clinical trial NCT02118168: Observational Study for the Extended Follow-up of the Patients Enrolled in the Therapeutic Clinical Trial ISS T-002
Official title: OBSERVATIONAL STUDY FOR THE EXTENDED FOLLOW-UP OF THE PATIENTS ENROLLED IN THE PHASE II THERAPEUTIC CLINICAL TRIAL ISS T-002
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infection
Keywords: HIV
HAART
Tat Protein
Lead sponsor: Istituto Superiore di Sanità
Sponsor class: OTHER
First posted: 2014-04-21
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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.

Primary outcomes:
measure: anti-Tat humoral immune response
timeFrame: Every 3 months, up to 2.5 years
Secondary outcomes:
measure: Testing of the additional Immunological parameters detailed below as a second line testing
timeFrame: Every 3 months, up to 2.5 years
measure: Testing of virological parameters detailed below, as a second line testing
timeFrame: Every 3 months, up to 2.5 years
Other outcomes:
Locations:
city: Monza
country: Italy
facility: Divisione di Malattie Infettive Azienda Ospedaliera S. Gerardo
state: MB
city: Bari
country: Italy
facility: Divisione Malattie Infettive - AO Ospedale Policlinico Consorziale
city: Ferrara
country: Italy
facility: Ambulatorio Malattie Infettive - AO Universitaria
city: Firenze
country: Italy
facility: Unità Operativa di Malattie Infettive - Ospedale S.M. Annunziata
city: Milano
country: Italy
facility: U. O. di Malattie Infettive Centro di Ricerca e Cura Patologie HIV correlate - Ospedale San Raffaele
city: Milano
country: Italy
facility: Istituto di Malattie Infettive e Tropicali - AO Luigi Sacco
city: Modena
country: Italy
facility: Divisione di Malattie Infettive - AO Universitaria Policlinico
city: Roma
country: Italy
facility: U.O.C. Dermatologia Infettiva ed Allergologica - IFO San Gallicano
Study officials:
affiliation: Istituto Superiore di Sanità
name: Barbara Ensoli, MD, PHD
role: STUDY_DIRECTOR
References:
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