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

NCT01024595 | Completed

• 1 other identifier: ISS OBS T-001
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 3

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.

Conditions

HIV Infection

Keywords

HIV; Tat protein

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

Study Arms (1)

Without treatment

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

Sponsors & Collaborators

• Istituto Superiore di Sanità: lead

Study Sites (3)

San Raffaele Hospital

Milan, 20127, Italy

Location

I.R.C.C.S. Spallanzani Hospital

Rome, 00100, Italy

Location

S. Gallicano Hospital

Rome, 00100, Italy

Location

Related 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. doi: 10.1038/345084a0.

  PMID: 2184372 BACKGROUND

• 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. doi: 10.1128/JVI.67.1.277-287.1993.

  PMID: 8416373 BACKGROUND

• 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. doi: 10.1038/371674a0.

  PMID: 7935812 BACKGROUND

• 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.

  PMID: 17117011 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood, serum, PBMCs

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 2, 2009
• First Posted: December 3, 2009
• Study Start: September 1, 2007
• Study Completion: December 1, 2010
• Last Updated: March 1, 2011

Record last verified: 2010-02

Locations

IT (3)