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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
Sponsor:
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.
Not Provided
Observational
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
whole blood, serum, PBMCs
Non-Probability Sample
Hiv-1-infected haart-treated adult subjects
HIV Infection
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
142
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)
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
 
NCT01024556
ISS OBS T-002
No
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