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

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ClinicalTrials.gov Identifier: NCT01024595
Recruitment Status : Completed
First Posted : December 3, 2009
Last Update Posted : March 1, 2011
Information provided by:

December 2, 2009
December 3, 2009
March 1, 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
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
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.
December 2010
Not Provided

Inclusion Criteria:

  • Previous participation to the phase I clinical trial ISS T-001
Sexes Eligible for Study: All
18 Years to 50 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
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