Observational Study on Anti-Tat Immune Response in HIV-1-infected Asymptomatic Adult Subjects (ISS OBS T-003)

Barbara Ensoli, MD

Status: Completed

Conditions: HIV Infections

Study type: Observational

Funder types: Other

Identifiers

NCT01029548

ISS OBS T-003

Details and patient eligibility

About

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.

Enrollment: 73 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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