Observational Study on Anti-Tat Immune Response in HIV-1-infected Asymptomatic Adult Subjects (ISS OBS T-003)

This study has been terminated.
(Low enrollment rate and low patients compliance to visit schedule)
Sponsor:
Information provided by:
Istituto Superiore di Sanita
ClinicalTrials.gov Identifier:
NCT01029548
First received: December 9, 2009
Last updated: May 30, 2012
Last verified: May 2012

December 9, 2009
May 30, 2012
April 2008
Not Provided
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.
Same as current
Complete list of historical versions of study NCT01029548 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
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

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, that will evaluate a large number of subjects, will provide important information for the design, planning and conduction of future therapeutic vaccine trials based on the HIV-1 Tat protein in asymptomatic subjects.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Whole Blood, serum, PBMCs

Non-Probability Sample

Asymptomatic HIV infected individuals

HIV Infections
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
Not Provided
May 2012
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01029548
ISS OBS T-003
No
Barbara Ensoli, CNAIDS - Istituto Superiore di Sanita
Istituto Superiore di Sanita
Not Provided
Principal Investigator: Francesco Mazzotta, MD A.M. Annunziata Hospital Florence, Italy
Principal Investigator: Giuseppe Pastore, MD General Hospital of Bari
Principal Investigator: Florio Ghinelli, MD General Hospital-University of Ferrara
Principal Investigator: Roberto Esposito, MD General Hospital-University of Modena
Principal Investigator: Massimo Galli, MD L.Sacco Hospital - MI
Principal Investigator: Fabrizio Soscia, MD S.M. Goretti Hospital Latina
Principal Investigator: Guido Palamara, MD San Gallicano Hospital - Rome
Principal Investigator: Adriano Lazzarin, MD San Raffaele Hospital - Milan
Principal Investigator: Giampiero Carosi, MD Spedali Civili - Brescia
Principal Investigator: Giovanni Di Perri, MD Amedeo di Savoia Hospital - Turin
Istituto Superiore di Sanita
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP