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

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ClinicalTrials.gov Identifier: NCT01029548

Recruitment Status : Completed

First Posted : December 10, 2009

Last Update Posted : March 4, 2016

Sponsor:

Information provided by (Responsible Party):

Barbara Ensoli, MD, Istituto Superiore di Sanità

Study Description

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 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 or disease
HIV Infections

Study Design


Study Type :	Observational
Actual Enrollment :	73 participants
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
Study Start Date :	April 2008
Actual Study Completion Date :	May 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

Publications of Results:

Bellino S, Tripiciano A, Picconi O, Francavilla V, Longo O, Sgadari C, Paniccia G, Arancio A, Angarano G, Ladisa N, Lazzarin A, Tambussi G, Nozza S, Torti C, Focà E, Palamara G, Latini A, Sighinolfi L, Mazzotta F, Di Pietro M, Di Perri G, Bonora S, Mercurio VS, Mussini C, Gori A, Galli M, Monini P, Cafaro A, Ensoli F, Ensoli B. The presence of anti-Tat antibodies in HIV-infected individuals is associated with containment of CD4+ T-cell decay and viral load, and with delay of disease progression: results of a 3-year cohort study. Retrovirology. 2014 Jun 24;11:49. doi: 10.1186/1742-4690-11-49.

Other 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.

Ensoli B, Cafaro A, Monini P, Marcotullio S, Ensoli F. Challenges in HIV Vaccine Research for Treatment and Prevention. Front Immunol. 2014 Sep 8;5:417. doi: 10.3389/fimmu.2014.00417. eCollection 2014. Review.

Ensoli F, Cafaro A, Casabianca A, Tripiciano A, Bellino S, Longo O, Francavilla V, Picconi O, Sgadari C, Moretti S, Cossut MR, Arancio A, Orlandi C, Sernicola L, Maggiorella MT, Paniccia G, Mussini C, Lazzarin A, Sighinolfi L, Palamara G, Gori A, Angarano G, Di Pietro M, Galli M, Mercurio VS, Castelli F, Di Perri G, Monini P, Magnani M, Garaci E, Ensoli B. HIV-1 Tat immunization restores immune homeostasis and attacks the HAART-resistant blood HIV DNA: results of a randomized phase II exploratory clinical trial. Retrovirology. 2015 Apr 29;12:33. doi: 10.1186/s12977-015-0151-y.

Cafaro A, Tripiciano A, Sgadari C, Bellino S, Picconi O, Longo O, Francavilla V, Buttò S, Titti F, Monini P, Ensoli F, Ensoli B. Development of a novel AIDS vaccine: the HIV-1 transactivator of transcription protein vaccine. Expert Opin Biol Ther. 2015;15 Suppl 1:S13-29. doi: 10.1517/14712598.2015.1021328. Epub 2015 Jun 22. Review.

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. doi: 10.1371/journal.pone.0013540.

Monini P, Cafaro A, Srivastava IK, Moretti S, Sharma VA, Andreini C, Chiozzini C, Ferrantelli F, Cossut MR, Tripiciano A, Nappi F, Longo O, Bellino S, Picconi O, Fanales-Belasio E, Borsetti A, Toschi E, Schiavoni I, Bacigalupo I, Kan E, Sernicola L, Maggiorella MT, Montin K, Porcu M, Leone P, Leone P, Collacchi B, Palladino C, Ridolfi B, Falchi M, Macchia I, Ulmer JB, Buttò S, Sgadari C, Magnani M, Federico MP, Titti F, Banci L, Dallocchio F, Rappuoli R, Ensoli F, Barnett SW, Garaci E, Ensoli B. HIV-1 tat promotes integrin-mediated HIV transmission to dendritic cells by binding Env spikes and competes neutralization by anti-HIV antibodies. PLoS One. 2012;7(11):e48781. doi: 10.1371/journal.pone.0048781. Epub 2012 Nov 13.


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
First Posted:	December 10, 2009 Key Record Dates
Last Update Posted:	March 4, 2016
Last Verified:	March 2016

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


HIV Therapeutic Vaccine

Additional relevant MeSH terms:


HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases	Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases

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