Observational Study of the Therapeutic Study of Recombinant HIV-1 TAT (ISS OBS T-001)
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.
|Study Design:||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|
- 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).
- 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
|Study Start Date:||September 2007|
|Study Completion Date:||December 2010|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01024595
|San Raffaele Hospital|
|Milan, Italy, 20127|
|I.R.C.C.S. Spallanzani Hospital|
|Rome, Italy, 00100|
|S. Gallicano Hospital|
|Rome, Italy, 00100|
|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|