Observational Study of the Therapeutic Study of Recombinant HIV-1 TAT (ISS OBS T-001)

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ClinicalTrials.gov Identifier: NCT01024595

Recruitment Status : Completed

First Posted : December 3, 2009

Last Update Posted : March 1, 2011

Sponsor:

Information provided by:

Istituto Superiore di Sanità

Study Description

Brief Summary:

The results of the Phase I Safety and Immunogenicity Trial of Recombinant HIV-1 Tat (ISS P-001 and ISS T-001) indicate that the vaccine based on the recombinant Tat protein is safe, well tolerated and immunogenic. The present study is intended to extend the follow-up of the volunteers for additional 3 years to evaluate the persistence of the anti-Tat humoral and cellular immune responses. The results of the present study will be key for the design of future phase II trials, particularly for the definition of the optimal schedule for boosting immunizations.

All individuals (27) will be enrolled in a 120-weeks observational study and monitored every 24 weeks for the following 3 years. During these visits, which are performed within the schedule indicated for the clinical monitoring of HIV-1 infected individuals, in addition to the routine virological, hematological and biochemical assessment, the anti-Tat specific humoral and cellular immune responses will be evaluated.

Condition or disease
HIV Infection

Study Design

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Study Type :	Observational
Actual Enrollment :	24 participants
Time Perspective:	Prospective
Official Title:	Observational Study of the Phase I Safety and Immunogenicity Trial of Recombinant HIV-1 Tat in Hiv-1 Infected Adult Volunteers
Study Start Date :	September 2007
Actual Study Completion Date :	December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Without treatment

Outcome Measures

Primary Outcome Measures :

To evaluate the persistence of specific immune responses, volunteers will be monitored for anti-Tat specific antibodies, anti-Tat proliferative response and in vitro γIFN and IL-4 production in response to Tat (Elispot).

Secondary Outcome Measures :

To develop test procedures in order to evaluate humoral and cellular anti-Tat immunity for future efficacy trials.

Biospecimen Retention: Samples Without DNA

Whole blood, serum, PBMCs

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 50 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

HIV-1 Infected subject previously included in the Phase I Clinical Trial with Tat protein

Criteria

Inclusion Criteria:

Previous participation to the phase I clinical trial ISS T-001

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): NCT01024595

Locations

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Italy
San Raffaele Hospital
Milan, Italy, 20127
I.R.C.C.S. Spallanzani Hospital
Rome, Italy, 00100
S. Gallicano Hospital
Rome, Italy, 00100

Sponsors and Collaborators

Istituto Superiore di Sanità

Investigators

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Principal Investigator:	Adriano Lazzarin, MD	San Raffaele Hospital - Milan, Italy
Principal Investigator:	Aldo Di Carlo, MD	S. Gallicano Hospital- Rome, Italy
Principal Investigator:	Pasquale Narciso, MD	I.R.C.C.S. Spallanzani Hospital, Rome

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

Publications:

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, Gendelman R, Markham P, Fiorelli V, Colombini S, Raffeld M, Cafaro A, Chang HK, Brady JN, Gallo RC. Synergy between basic fibroblast growth factor and HIV-1 Tat protein in induction of Kaposi's sarcoma. Nature. 1994 Oct 20;371(6499):674-80.

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.

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Responsible Party:	Barbara Ensoli, CNAIDS - Istituto Superiore di Sanita
ClinicalTrials.gov Identifier:	NCT01024595
Other Study ID Numbers:	ISS OBS T-001
First Posted:	December 3, 2009 Key Record Dates
Last Update Posted:	March 1, 2011
Last Verified:	February 2010

Keywords provided by Istituto Superiore di Sanità:


HIV Tat protein

Additional relevant MeSH terms:

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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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