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

NCT01024556 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 142

Last updated 2016-03-04

No results posted yet for this study

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.

Conditions

  • HIV Infection

Sponsors & Collaborators

  • Barbara Ensoli, MD

    lead OTHER

Principal Investigators

  • Roberto Esposito, MD · Azienda Ospedaliero - Universitaria Policlinico di Modena, Modena, Italy

  • Giovanni Di Perri, MD · Amedeo di Savoia Hospital, Turin, Italy

  • Adriano Lazzarin, MD · San Raffaele Hospital - Milan, Italy

  • Massimo Galli, MD · L. Sacco Hospital- Milan, Italy

  • Giampiero Carosi, MD · "Spedali Civili" di Brescia , Brescia, Italy

  • Florio Ghinelli, MD · Azienda Ospedaliero - Universitaria di Ferrara, Ferrara, Italy

  • Francesco Mazzotta, MD · S. M. Annunziata Hospital, Florence, Italy

  • Guido Palamara, MD · S. Gallicano Hospital- Rome, Italy

  • Fabrizio Soscia, MD · S. M. Goretti Hospital- Latina, Italy

  • Giuseppe Pastore, MD · "Ospedale Policlinico Consorziale"-Bari, Italy

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-31
Completion
2012-02-29

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01024556 on ClinicalTrials.gov