Observational Study on Anti-Tat Immune Response in HIV-1-infected HAART-treated Adult Subjects (ISS OBS T-002)

Barbara Ensoli, MD

Status: Completed

Conditions: HIV Infection

Study type: Observational

Funder types: Other

Identifiers

NCT01024556

ISS OBS T-002

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 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.

Enrollment: 142 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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