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

Completed

• Conditions: HIV Infections

• Registration Number: NCT01029548
• 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 HIV-1 infected asymptomatic individuals, and to prospectively evaluate the immunological, virological and clinical outcome of anti-Tat positive versus anti-Tat negative drug naїve subjects (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 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 asymptomatic subjects.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2009-12-09
• Study First Submitted QC: 2009-12-09
• Study First Posted: 2009-12-10
• Study Completion: 2012-05
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-03
• Last Update Posted: 2016-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

Inclusion Criteria

• To be clinically asymptomatic HIV-1 infected individuals with CD4+ T cell counts ≥400/μL
• To be naïve for antiretroviral therapy
• Levels of plasma viremia ≤100,000 copies/ml at baseline
• Age ≥ 18 years
• 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
Specific humoral and cellular immune responses to Tat will be monitored by assessing anti-Tat specific antibodies in sera, proliferative response (CFSE) and production of γIFN, IL-4 and IL-2 (Elispot) by peripheral blood mononuclear cells.

Secondary Outcome Measures

Name	Time	Method
The decline of CD4+ T cells count, the increase of the HIV plasma viral load or the occurrence of AIDS-defining events will be assessed to determine the progression to disease

Trial Locations

Locations (10)

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

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

San Raffaele Hospital; 🇮🇹 Milan, Italy

General Hospital of Bari; 🇮🇹 Bari, Italy

San Gallicano Hospital; 🇮🇹 Rome, Italy

Giovanni Di Perri; 🇮🇹 Turin, Italy

Spedali Civili di Brescia; 🇮🇹 Brescia, Italy

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

L. Sacco Hospital; 🇮🇹 Milan, Italy

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