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

NCT01029548 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 73

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 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.

Conditions

  • HIV Infections

Sponsors & Collaborators

  • Barbara Ensoli, MD

    lead OTHER

Principal Investigators

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

  • Giuseppe Pastore, MD · General Hospital of Bari

  • Florio Ghinelli, MD · General Hospital-University of Ferrara

  • Roberto Esposito, MD · General Hospital-University of Modena

  • Massimo Galli, MD · L.Sacco Hospital - MI

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

  • Guido Palamara, MD · San Gallicano Hospital - Rome

  • Adriano Lazzarin, MD · San Raffaele Hospital - Milan

  • Giampiero Carosi, MD · Spedali Civili - Brescia

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

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Completion
2012-05-31

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 NCT01029548 on ClinicalTrials.gov