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Trial record 24 of 1247 for:    "Observational" [STUDY-TYPES] AND HIV [CONDITION]

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

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ClinicalTrials.gov Identifier: NCT01029548
Recruitment Status : Completed
First Posted : December 10, 2009
Last Update Posted : March 4, 2016
Sponsor:
Information provided by (Responsible Party):
Barbara Ensoli, MD, Istituto Superiore di Sanità

Tracking Information
First Submitted Date December 9, 2009
First Posted Date December 10, 2009
Last Update Posted Date March 4, 2016
Study Start Date April 2008
Primary Completion Date Not Provided
Current Primary Outcome Measures
 (submitted: December 9, 2009)
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01029548 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: December 9, 2009)
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
Original Secondary Outcome Measures Same as current
Current Other Outcome Measures Not Provided
Original Other Outcome Measures Not Provided
 
Descriptive Information
Brief Title Observational Study on Anti-Tat Immune Response in HIV-1-infected Asymptomatic Adult Subjects
Official Title Observational Study With Additional Diagnostic Procedures on Anti-Tat Immune Response in HIV-1-infected Asymptomatic Adult Subjects
Brief 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Whole Blood, serum, PBMCs
Sampling Method Non-Probability Sample
Study Population Asymptomatic HIV infected individuals
Condition HIV Infections
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 3, 2016)
73
Original Enrollment Not Provided
Actual Study Completion Date May 2012
Primary Completion Date Not Provided
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT01029548
Other Study ID Numbers ISS OBS T-003
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Barbara Ensoli, MD, Istituto Superiore di Sanità
Study Sponsor Barbara Ensoli, MD
Collaborators Not Provided
Investigators
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
PRS Account Istituto Superiore di Sanità
Verification Date March 2016