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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Barbara Ensoli, MD, Istituto Superiore di Sanità
ClinicalTrials.gov Identifier:
NCT01029548
First received: December 9, 2009
Last updated: March 3, 2016
Last verified: March 2016

December 9, 2009
March 3, 2016
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 provided 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.
 
Completed
73
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
Not Provided
Not Provided
Barbara Ensoli, MD, Istituto Superiore di Sanità
Barbara Ensoli, MD
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 Sanità
March 2016

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