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 Sanita

ClinicalTrials.gov Identifier:

NCT01024595

First received: December 2, 2009

Last updated: February 28, 2011

Last verified: February 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

December 2, 2009

Last Updated Date

February 28, 2011

Start Date ^ICMJE

September 2007

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

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 ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01024595 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To develop test procedures in order to evaluate humoral and cellular anti-Tat immunity for future efficacy trials.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Observational Study of the Therapeutic Study of Recombinant HIV-1 TAT

Official Title ^ICMJE

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 ^ICMJE

Observational

Study Design ^ICMJE

Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Retention: Samples Without DNA

Description:

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 ^ICMJE

HIV Infection

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Without treatment

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 2010

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Gender

Both

Ages

18 Years to 50 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Italy

Administrative Information

NCT Number ^ICMJE

NCT01024595

Other Study ID Numbers ^ICMJE

ISS OBS T-001

Has Data Monitoring Committee

Responsible Party

Barbara Ensoli, CNAIDS - Istituto Superiore di Sanita

Study Sponsor ^ICMJE

Istituto Superiore di Sanita

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

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

Information Provided By

Istituto Superiore di Sanita

Verification Date

February 2010

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

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