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

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:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

Further study details as provided by Istituto Superiore di Sanita:

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

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 Sanita

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:

Related Info This link exits the ClinicalTrials.gov site

Publications:

André P, Groettrup M, Klenerman P, de Giuli R, Booth BL Jr, Cerundolo V, Bonneville M, Jotereau F, Zinkernagel RM, Lotteau V. An inhibitor of HIV-1 protease modulates proteasome activity, antigen presentation, and T cell responses. Proc Natl Acad Sci U S A. 1998 Oct 27;95(22):13120-4.

Arya SK, Guo C, Josephs SF, Wong-Staal F. Trans-activator gene of human T-lymphotropic virus type III (HTLV-III). Science. 1985 Jul 5;229(4708):69-73.

Ensoli B, Barillari G, Salahuddin SZ, Gallo RC, Wong-Staal F. Tat protein of HIV-1 stimulates growth of cells derived from Kaposi's sarcoma lesions of AIDS patients. Nature. 1990 May 3;345(6270):84-6.

Ensoli B, Buonaguro L, Barillari G, Fiorelli V, Gendelman R, Morgan RA, Wingfield P, Gallo RC. Release, uptake, and effects of extracellular human immunodeficiency virus type 1 Tat protein on cell growth and viral transactivation. J Virol. 1993 Jan;67(1):277-87.

Ensoli B, Fiorelli V, Ensoli F, Cafaro A, Titti F, Butto 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. No abstract available.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Ensoli B, Bellino S, Tripiciano A, Longo O, Francavilla V, Marcotullio S, Cafaro A, Picconi O, Paniccia G, Scoglio A, Arancio A, Ariola C, Ruiz Alvarez MJ, Campagna M, Scaramuzzi D, Iori C, Esposito R, Mussini C, Ghinelli F, Sighinolfi L, Palamara G, Latini A, Angarano G, Ladisa N, Soscia F, Mercurio VS, Lazzarin A, Tambussi G, Visintini R, Mazzotta F, Di Pietro M, Galli M, Rusconi S, Carosi G, Torti C, Di Perri G, Bonora S, Ensoli F, Garaci E. Therapeutic immunization with HIV-1 Tat reduces immune activation and loss of regulatory T-cells and improves immune function in subjects on HAART. PLoS One. 2010 Nov 11;5(11):e13540.

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 Sanita:

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 May 19, 2013