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

This study has been completed.
Sponsor:
Information provided by:
Istituto Superiore di Sanità
ClinicalTrials.gov Identifier:
NCT01024595
First received: December 2, 2009
Last updated: February 28, 2011
Last verified: February 2010
History of Changes

December 2, 2009
February 28, 2011
September 2007
Not Provided
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).
Same as current
Complete list of historical versions of study NCT01024595 on ClinicalTrials.gov Archive Site
To develop test procedures in order to evaluate humoral and cellular anti-Tat immunity for future efficacy trials.
Same as current
Not Provided
Not Provided
 
Observational Study of the Therapeutic Study of Recombinant HIV-1 TAT
Observational Study of the Phase I Safety and Immunogenicity Trial of Recombinant HIV-1 Tat in Hiv-1 Infected Adult Volunteers

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.
Not Provided
Observational
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Whole blood, serum, PBMCs
Non-Probability Sample

HIV-1 Infected subject previously included in the Phase I Clinical Trial with Tat protein
HIV Infection
Not Provided
Without treatment

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
December 2010
Not Provided

Inclusion Criteria:

  • Previous participation to the phase I clinical trial ISS T-001
Both
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01024595
ISS OBS T-001
No
Barbara Ensoli, CNAIDS - Istituto Superiore di Sanita
Istituto Superiore di Sanità
Not Provided
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
Istituto Superiore di Sanità
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP