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Trial record 7 of 1247 for:    "Observational" [STUDY-TYPES] AND HIV [CONDITION]

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

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ClinicalTrials.gov Identifier: NCT01024556
Recruitment Status : Completed
First Posted : December 2, 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 1, 2009
First Posted Date December 2, 2009
Last Update Posted Date March 4, 2016
Study Start Date March 2008
Primary Completion Date Not Provided
Current Primary Outcome Measures
 (submitted: December 1, 2009)
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01024556 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: March 3, 2016)
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.
Original Secondary Outcome Measures
 (submitted: December 1, 2009)
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.
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 HAART-treated Adult Subjects
Official Title Observational Study With Additional Diagnostic Procedures on Anti-Tat Immune Response in HIV-1-infected HAART-treated 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 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.
Detailed Description Not Provided
Study Type Observational
Study Design 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 Hiv-1-infected haart-treated adult subjects
Condition HIV Infection
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)
142
Original Enrollment Not Provided
Actual Study Completion Date February 2012
Primary Completion Date Not Provided
Eligibility Criteria

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
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 NCT01024556
Other Study ID Numbers ISS OBS T-002
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: 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
PRS Account Istituto Superiore di Sanità
Verification Date March 2016