Clinical trial NCT01024556: Observational Study on Anti-Tat Immune Response in HIV-1-infected HAART-treated Adult Subjects
Official title: Observational Study With Additional Diagnostic Procedures on Anti-Tat Immune Response in HIV-1-infected HAART-treated Adult Subjects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infection
Keywords: HIV, HAART
Lead sponsor: Istituto Superiore di Sanità
Sponsor class: OTHER
First posted: 2009-12-02
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hiv-1-infected haart-treated adult subjects

Brief summary: The present study is designed as a prospective observational study directed at evaluating the frequency, magnitude, quality and persistence (primary endpoint) of the anti-Tat immune response in highly active antiretroviral therapy (HAART)-receiving HIV-1 infected individuals, and to prospectively evaluate the immunological, virological and clinical outcome of anti-Tat positive versus anti-Tat negative subjects under successful HAART (secondary endpoint), in order to determine the impact of anti-Tat immunity on HIV disease progression as well as the potential use of anti-Tat immune response assessment for the clinical and therapeutic management of HAART-treated infected patients. This survey provided important information for the design, planning and conduction of future therapeutic vaccine trials based on the HIV-1 Tat protein in HAART-treated patients.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of HIV-1 infection
* To be under successful HAART treatment with plasma viremia \<50 copies/ml in the last 6 months prior to initiation of the study, without a history of virologic rebound
* Known CD4+ T cells nadir
* Age ≥ 18 years old
* Signed informed consent

Exclusion Criteria:

* Current therapy with immunomodulators or immunosuppressive drugs, or chemotherapy for neoplastic disorders
* Concomitant treatment for HBV or HCV infection

Primary outcomes:
measure: Assessment of anti-Tat antibodies in sera of subjects, and of the proliferative response (CFSE) and the production of γIFN, IL-4 and IL-2 (Elispot) by peripheral blood mononuclear cells (PBMC) in response to Tat.
Secondary outcomes:
measure: The decline of CD4+ T cell counts, the increase of HIV plasma viral load or the occurrence of AIDS-defining events were assessed to determine progression to disease.
Other outcomes:
Locations:
city: Latina
country: Italy
facility: S.M. Goretti Hospital
state: Rome
city: Bari
country: Italy
facility: General Hospital of Bari
city: Brescia
country: Italy
facility: Spedali Civili di Brescia
city: Ferrara
country: Italy
facility: General Hospital-University of Ferrara
city: Florence
country: Italy
facility: A.M. Annunziata Hospital
city: Milan
country: Italy
facility: L. Sacco Hospital
city: Milan
country: Italy
facility: San Raffaele Hospital
city: Modena
country: Italy
facility: General Hospital-University of Modena
city: Rome
country: Italy
facility: San Gallicano Hospital
city: Torino
country: Italy
facility: Amedeo di Savoia Hospital
Study officials:
affiliation: Azienda Ospedaliero - Universitaria Policlinico di Modena, Modena, Italy
name: Roberto Esposito, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Amedeo di Savoia Hospital, Turin, Italy
name: Giovanni Di Perri, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: San Raffaele Hospital - Milan, Italy
name: Adriano Lazzarin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: L. Sacco Hospital- Milan, Italy
name: Massimo Galli, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: "Spedali Civili" di Brescia , Brescia, Italy
name: Giampiero Carosi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Azienda Ospedaliero - Universitaria di Ferrara, Ferrara, Italy
name: Florio Ghinelli, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: S. M. Annunziata Hospital, Florence, Italy
name: Francesco Mazzotta, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: S. Gallicano Hospital- Rome, Italy
name: Guido Palamara, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: S. M. Goretti Hospital- Latina, Italy
name: Fabrizio Soscia, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: "Ospedale Policlinico Consorziale"-Bari, Italy
name: Giuseppe Pastore, MD
role: PRINCIPAL_INVESTIGATOR
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