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

This study has been terminated.

(Low enrollment rate and low patients compliance to visit schedule)

Sponsor:

Information provided by:

Istituto Superiore di Sanità

ClinicalTrials.gov Identifier:

NCT01029548

First received: December 9, 2009

Last updated: May 30, 2012

Last verified: May 2012

History of Changes

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, 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 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

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

Further study details as provided by 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


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

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

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

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

Istituto Superiore di Sanità

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

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

Publications:

Ensoli B, Fiorelli V, Ensoli F, Cafaro A, Titti F, Buttò S, Monini P, Magnani M, Caputo A, Garaci E. Candidate HIV-1 Tat vaccine development: from basic science to clinical trials. AIDS. 2006 Nov 28;20(18):2245-61. Review.

Rezza G, Fiorelli V, Dorrucci M, Ciccozzi M, Tripiciano A, Scoglio A, Collacchi B, Ruiz-Alvarez M, Giannetto C, Caputo A, Tomasoni L, Castelli F, Sciandra M, Sinicco A, Ensoli F, Buttò S, Ensoli B. The presence of anti-Tat antibodies is predictive of long-term nonprogression to AIDS or severe immunodeficiency: findings in a cohort of HIV-1 seroconverters. J Infect Dis. 2005 Apr 15;191(8):1321-4. Epub 2005 Mar 14.

Rodman TC, To SE, Hashish H, Manchester K. Epitopes for natural antibodies of human immunodeficiency virus (HIV)-negative (normal) and HIV-positive sera are coincident with two key functional sequences of HIV Tat protein. Proc Natl Acad Sci U S A. 1993 Aug 15;90(16):7719-23.


Responsible Party:	Barbara Ensoli, CNAIDS - Istituto Superiore di Sanita
ClinicalTrials.gov Identifier:	NCT01029548 History of Changes
Other Study ID Numbers:	ISS OBS T-003
Study First Received:	December 9, 2009
Last Updated:	May 30, 2012
Health Authority:	Italy: The Italian Medicines Agency

Keywords provided by Istituto Superiore di Sanità:


HIV Therapeutic Vaccine

ClinicalTrials.gov processed this record on February 27, 2015

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