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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01024556
Recruitment Status : Completed
First Posted : December 2, 2009
Last Update Posted : March 4, 2016
Information provided by (Responsible Party):

December 1, 2009
December 2, 2009
March 4, 2016
March 2008
Not Provided
Assessment of anti-Tat antibodies in sera of subjects, and of the proliferative response (CFSE) and the production of γIFN, IL-4 and IL-2 (Elispot) by peripheral blood mononuclear cells (PBMC) in response to Tat.
Same as current
Complete list of historical versions of study NCT01024556 on ClinicalTrials.gov Archive Site
The decline of CD4+ T cell counts, the increase of HIV plasma viral load or the occurrence of AIDS-defining events were assessed to determine progression to disease.
The decline of CD4+ T cell counts, the increase of HIV plasma viral load or the occurrence of AIDS-defining events will be assessed to determine progression to disease.
Not Provided
Not Provided
Observational Study on Anti-Tat Immune Response in HIV-1-infected HAART-treated Adult Subjects
Observational Study With Additional Diagnostic Procedures on Anti-Tat Immune Response in HIV-1-infected HAART-treated Adult Subjects
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.
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Time Perspective: Prospective
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Retention:   Samples With DNA
whole blood, serum, PBMCs
Non-Probability Sample
Hiv-1-infected haart-treated adult subjects
HIV Infection
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
February 2012
Not Provided

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Barbara Ensoli, MD, Istituto Superiore di Sanità
Barbara Ensoli, MD
Not Provided
Principal Investigator: Roberto Esposito, MD Azienda Ospedaliero - Universitaria Policlinico di Modena, Modena, Italy
Principal Investigator: Giovanni Di Perri, MD Amedeo di Savoia Hospital, Turin, Italy
Principal Investigator: Adriano Lazzarin, MD San Raffaele Hospital - Milan, Italy
Principal Investigator: Massimo Galli, MD L. Sacco Hospital- Milan, Italy
Principal Investigator: Giampiero Carosi, MD "Spedali Civili" di Brescia , Brescia, Italy
Principal Investigator: Florio Ghinelli, MD Azienda Ospedaliero - Universitaria di Ferrara, Ferrara, Italy
Principal Investigator: Francesco Mazzotta, MD S. M. Annunziata Hospital, Florence, Italy
Principal Investigator: Guido Palamara, MD S. Gallicano Hospital- Rome, Italy
Principal Investigator: Fabrizio Soscia, MD S. M. Goretti Hospital- Latina, Italy
Principal Investigator: Giuseppe Pastore, MD "Ospedale Policlinico Consorziale"-Bari, Italy
Istituto Superiore di Sanità
March 2016