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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01024595
Recruitment Status : Completed
First Posted : December 3, 2009
Last Update Posted : March 1, 2011
Information provided by:
Istituto Superiore di Sanità

Tracking Information
First Submitted Date December 2, 2009
First Posted Date December 3, 2009
Last Update Posted Date March 1, 2011
Study Start Date September 2007
Primary Completion Date Not Provided
Current Primary Outcome Measures
 (submitted: December 2, 2009)
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).
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: December 2, 2009)
To develop test procedures in order to evaluate humoral and cellular anti-Tat immunity for future efficacy trials.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title 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
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.

Detailed Description Not Provided
Study Type Observational
Study Design Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Whole blood, serum, PBMCs
Sampling Method Non-Probability Sample
Study Population HIV-1 Infected subject previously included in the Phase I Clinical Trial with Tat protein
Condition HIV Infection
Intervention Not Provided
Study Groups/Cohorts Without treatment
Publications *

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 2, 2009)
Original Actual Enrollment Same as current
Actual Study Completion Date December 2010
Primary Completion Date Not Provided
Eligibility Criteria

Inclusion Criteria:

  • Previous participation to the phase I clinical trial ISS T-001
Sexes Eligible for Study: All
Ages 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Italy
Removed Location Countries  
Administrative Information
NCT Number NCT01024595
Other Study ID Numbers ISS OBS T-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Barbara Ensoli, CNAIDS - Istituto Superiore di Sanita
Study Sponsor Istituto Superiore di Sanità
Collaborators 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
PRS Account Istituto Superiore di Sanità
Verification Date February 2010