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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

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.

Condition or disease
HIV Infection

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Study Type : Observational
Actual Enrollment : 24 participants
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
Study Start Date : September 2007
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Without treatment

Primary Outcome Measures :
  1. 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).

Secondary Outcome Measures :
  1. 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
HIV-1 Infected subject previously included in the Phase I Clinical Trial with Tat protein

Inclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01024595

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San Raffaele Hospital
Milan, Italy, 20127
I.R.C.C.S. Spallanzani Hospital
Rome, Italy, 00100
S. Gallicano Hospital
Rome, Italy, 00100
Sponsors and Collaborators
Istituto Superiore di Sanità
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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
Additional Information:
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Responsible Party: Barbara Ensoli, CNAIDS - Istituto Superiore di Sanita Identifier: NCT01024595    
Other Study ID Numbers: ISS OBS T-001
First Posted: December 3, 2009    Key Record Dates
Last Update Posted: March 1, 2011
Last Verified: February 2010
Keywords provided by Istituto Superiore di Sanità:
Tat protein
Additional relevant MeSH terms:
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HIV Infections
Blood-Borne Infections
Communicable Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases