Observational Study on Anti-Tat Immune Response in HIV-1-infected HAART-treated Adult Subjects

Completed

• Conditions: HIV Infection

• Registration Number: NCT01024556
• Lead Sponsor: Barbara Ensoli, MD

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2009-12-01
• Study First Submitted QC: 2009-12-01
• Study First Posted: 2009-12-02
• Study Completion: 2012-02
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-03
• Last Update Posted: 2016-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 142

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (10)

L. Sacco Hospital; 🇮🇹 Milan, Italy

San Raffaele Hospital; 🇮🇹 Milan, Italy

S.M. Goretti Hospital; 🇮🇹 Latina, Rome, Italy

General Hospital of Bari; 🇮🇹 Bari, Italy

Spedali Civili di Brescia; 🇮🇹 Brescia, Italy

General Hospital-University of Ferrara; 🇮🇹 Ferrara, Italy

A.M. Annunziata Hospital; 🇮🇹 Florence, Italy

General Hospital-University of Modena; 🇮🇹 Modena, Italy

San Gallicano Hospital; 🇮🇹 Rome, Italy

Amedeo di Savoia Hospital; 🇮🇹 Torino, Italy