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

• Sponsor: Barbara Ensoli, MD (Other)
• Overall Status: Completed
• CT.gov ID: NCT01029548
• Collaborator: (none)
• Enrollment: 73
• Locations: 10
• Duration (Months): 49
• Patients Per Site: 7.3
• Patients Per Site Per Month: 0.1

Study Details

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	Intervention/Treatment	Phase
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: Apr 1, 2008
• Actual Study Completion Date: May 1, 2012

Outcome Measures

Primary Outcome Measures

1. 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

1. 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 []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	S.M. Goretti Hospital	Latina	Rome	Italy
2	General Hospital of Bari	Bari		Italy
3	Spedali Civili di Brescia	Brescia		Italy
4	General Hospital-University of Ferrara	Ferrara		Italy
5	A.M. Annunziata Hospital	Florence		Italy
6	L. Sacco Hospital	Milan		Italy
7	San Raffaele Hospital	Milan		Italy
8	General Hospital-University of Modena	Modena		Italy	41100
9	San Gallicano Hospital	Rome		Italy
10	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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

• 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.
• 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 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.
• 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.
• 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.
• 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, MD, PhD, Istituto Superiore di Sanità
• ClinicalTrials.gov Identifier: NCT01029548
• Other Study ID Numbers: ISS OBS T-003
• First Posted: Dec 10, 2009
• Last Update Posted: Mar 4, 2016
• Last Verified: Mar 1, 2016

• Keywords provided by Barbara Ensoli, MD, PhD, Istituto Superiore di Sanità: HIV; Therapeutic Vaccine
• Additional relevant MeSH terms: HIV Infections

Study Results

No Results Posted as of Mar 4, 2016