Observational Study on Anti-Tat Immune Response in HIV-1-infected Asymptomatic Adult Subjects

NCT ID: NCT01029548

Last Updated: 2016-03-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 73 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2012-05-31

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.

Conditions

HIV Infections

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Barbara Ensoli, MD

OTHER

Sponsor Role: lead

Responsible Party

Barbara Ensoli, MD

PhD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Francesco Mazzotta, MD

Role: PRINCIPAL_INVESTIGATOR

A.M. Annunziata Hospital Florence, Italy

Giuseppe Pastore, MD

Role: PRINCIPAL_INVESTIGATOR

General Hospital of Bari

Florio Ghinelli, MD

Role: PRINCIPAL_INVESTIGATOR

General Hospital-University of Ferrara

Roberto Esposito, MD

Role: PRINCIPAL_INVESTIGATOR

General Hospital-University of Modena

Massimo Galli, MD

Role: PRINCIPAL_INVESTIGATOR

L.Sacco Hospital - MI

Fabrizio Soscia, MD

Role: PRINCIPAL_INVESTIGATOR

S.M. Goretti Hospital Latina

Guido Palamara, MD

Role: PRINCIPAL_INVESTIGATOR

San Gallicano Hospital - Rome

Adriano Lazzarin, MD

Role: PRINCIPAL_INVESTIGATOR

San Raffaele Hospital - Milan

Giampiero Carosi, MD

Role: PRINCIPAL_INVESTIGATOR

Spedali Civili - Brescia

Giovanni Di Perri, MD

Role: PRINCIPAL_INVESTIGATOR

Amedeo di Savoia Hospital - Turin

Locations

Giovanni Di Perri

Turin, Italy, 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

San Gallicano Hospital

Rome, , Italy

Countries

Italy

References

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. doi: 10.1097/QAD.0b013e3280112cd1. No abstract available.

Reference Type: BACKGROUND

PMID: 17117011 (View on PubMed)

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, Butto 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. doi: 10.1086/428909. Epub 2005 Mar 14.

Reference Type: BACKGROUND

PMID: 15776379 (View on PubMed)

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. doi: 10.1073/pnas.90.16.7719.

Reference Type: BACKGROUND

PMID: 7689227 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25250026 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25924841 (View on PubMed)

Cafaro A, Tripiciano A, Sgadari C, Bellino S, Picconi O, Longo O, Francavilla V, Butto 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.

Reference Type: BACKGROUND

PMID: 26096836 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21085635 (View on PubMed)

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, Butto 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.

Reference Type: BACKGROUND

PMID: 23152803 (View on PubMed)

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, Foca 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.

Reference Type: RESULT

PMID: 24961156 (View on PubMed)

Related Links

http://www.hiv1tat-vaccines.info

Related Info

Other Identifiers

ISS OBS T-003

Identifier Type: -

Identifier Source: org_study_id