Observational Study on Anti-tat Immune Response in HIV-1-infected HAART-treated Adult Subjects

This study has been terminated.
(Low enrollment rate and low patients compliance to the visit schedule)
Sponsor:
Information provided by:
Istituto Superiore di Sanità
ClinicalTrials.gov Identifier:
NCT01024556
First received: December 1, 2009
Last updated: April 24, 2012
Last verified: April 2012
  Purpose

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, 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 HAART-treated patients.


Condition
HIV Infection

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Observational Study With Additional Diagnostic Procedures on Anti-tat Immune Response in HIV-1-infected HAART-treated Adult Subjects

Resource links provided by NLM:


Further study details as provided by Istituto Superiore di Sanità:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • 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.

Biospecimen Retention:   Samples With DNA

whole blood, serum, PBMCs


Study Start Date: March 2008
Estimated Study Completion Date: June 2013
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Hiv-1-infected haart-treated adult subjects

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01024556

Locations
Italy
S.M. Goretti Hospital
Latina, Rome, Italy
General Hospital of Bari
Bari, Italy
Spedali Civili di Brescia
Brescia, Italy
General Hospital-University of Ferrara
Ferrara, Italy
A.M. Annunziata Hospital
Florence, Italy
L. Sacco Hospital
Milan, Italy
San Raffaele Hospital
Milan, Italy
General Hospital-University of Modena
Modena, Italy, 41100
San Gallicano Hospital
Rome, Italy
Amedeo di Savoia Hospital
Torino, Italy
Sponsors and Collaborators
Istituto Superiore di Sanità
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
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Barbara Ensoli, CNAIDS - Istituto Superiore di Sanita
ClinicalTrials.gov Identifier: NCT01024556     History of Changes
Other Study ID Numbers: ISS OBS T-002
Study First Received: December 1, 2009
Last Updated: April 24, 2012
Health Authority: Italy: The Italian Medicines Agency

Keywords provided by Istituto Superiore di Sanità:
HIV, HAART

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on September 18, 2014