Clinical trial NCT01024595: Observational Study of the Therapeutic Study of Recombinant HIV-1 TAT
Official title: Observational Study of the Phase I Safety and Immunogenicity Trial of Recombinant HIV-1 Tat in Hiv-1 Infected Adult Volunteers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infection
Keywords: HIV
Tat protein
Lead sponsor: Istituto Superiore di Sanità
Sponsor class: OTHER
First posted: 2009-12-03
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HIV-1 Infected subject previously included in the Phase I Clinical Trial with Tat protein

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.


Eligibility criteria: Inclusion Criteria:

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

Primary outcomes:
measure: 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:
measure: To develop test procedures in order to evaluate humoral and cellular anti-Tat immunity for future efficacy trials.
Other outcomes:
Locations:
city: Milan
country: Italy
facility: San Raffaele Hospital
city: Rome
country: Italy
facility: I.R.C.C.S. Spallanzani Hospital
city: Rome
country: Italy
facility: S. Gallicano Hospital
Study officials:
affiliation: San Raffaele Hospital - Milan, Italy
name: Adriano Lazzarin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: S. Gallicano Hospital- Rome, Italy
name: Aldo Di Carlo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: I.R.C.C.S. Spallanzani Hospital, Rome
name: Pasquale Narciso, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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. doi: 10.1128/JVI.67.1.277-287.1993.
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. doi: 10.1038/371674a0.
citation: 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.