Observational Study of the Therapeutic Study of Recombinant HIV-1 TAT

HIV Infection Clinical Trial

— ISS OBS T-001  

Official title:

Observational Study of the Phase I Safety and Immunogenicity Trial of Recombinant HIV-1 Tat in Hiv-1 Infected Adult Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01024595
• Other study ID #: ISS OBS T-001
• Status: Completed
• Phase: N/A
• First received: December 2, 2009
• Last updated: February 28, 2011
• Start date: September 2007
• Est. completion date: December 2010

Study information

• Verified date: February 2010
• Source: Istituto Superiore di Sanità
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: The Italian Medicines Agency
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• HIV Infection

Locations

Country	Name	City	State
Italy	San Raffaele Hospital	Milan
Italy	I.R.C.C.S. Spallanzani Hospital	Rome
Italy	S. Gallicano Hospital	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Superiore di Sanità

Country where clinical trial is conducted

Italy, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the persistence of specific immune responses, volunteers will be monitored for anti-Tat specific antibodies, anti-Tat proliferative response and in vitro ?IFN and IL-4 production in response to Tat (Elispot).
Secondary	To develop test procedures in order to evaluate humoral and cellular anti-Tat immunity for future efficacy trials.

External Links

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