Clinical Trials

MainTitle

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

This study has been completed
Sponsor
Barbara Ensoli, MD


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
History of Changes
Purpose

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 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.

Condition
HIV Infections

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Study With Additional Diagnostic Procedures on Anti-Tat Immune Response in HIV-1-infected Asymptomatic Adult Subjects

Further study details as provided by Barbara Ensoli, MD, Istituto Superiore di Sanità:

Primary Outcome Measures

  • 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.
Secondary Outcome Measures:
  • 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

Biospecimen Retention: Samples With DNA
Whole Blood, serum, PBMCs

Enrollment: 73
Study Start Date: April 2008
Study Completion Date: May 2012

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  
Sampling Method: Non-Probability Sample  

Study Population

Asymptomatic HIV infected individuals

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

contacts and locations

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: NCT01029548

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
Giovanni Di Perri
Turin, Italy, 10149

Sponsors and Collaborators

Barbara Ensoli, MD

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
More Information

More Information

Additional Information:

Related Info

Additional Information:

Related Info

Responsible Party: Barbara Ensoli, MD, PhD, Istituto Superiore di Sanità  
ClinicalTrials.gov Identifier: NCT01029548   History of Changes  
Other Study ID Numbers: ISS OBS T-003  
Study First Received: December 9, 2009  
Last Updated: March 3, 2016  

Keywords provided by Barbara Ensoli, MD, Istituto Superiore di Sanità:

HIV
Therapeutic Vaccine

Additional relevant MeSH terms:
HIV Infections

ClinicalTrials.gov processed this data on December 11, 2017
This information is provided by ClinicalTrials.gov.