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

Observational Study With Additional Diagnostic Procedures on Anti-Tat Immune Response in HIV-1-infected Asymptomatic Adult Subjects

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01029548

Acronym

ISS OBS T-003

Enrollment

Registered

2009-12-10

Start date

2008-04-30

Completion date

2012-05-31

Last updated

2016-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

HIV, Therapeutic Vaccine

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Countries

Italy

Outcome results