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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:
Istituto Superiore di Sanità
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
| Tracking Information | ||||||||||
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| 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. |
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| 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 |
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| 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 Groups/Cohorts | Without treatment | |||||||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||||||||
| Recruitment Status ICMJE | Completed | |||||||||
| Enrollment ICMJE | 24 | |||||||||
| Completion Date | December 2010 | |||||||||
| Primary Completion Date | Not Provided | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years to 50 Years (Adult) | |||||||||
| Accepts Healthy Volunteers | No | |||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||||||||
| Listed Location Countries ICMJE | Italy | |||||||||
| Removed Location Countries | ||||||||||
| Administrative Information | ||||||||||
| NCT Number ICMJE | NCT01024595 | |||||||||
| Other Study ID Numbers ICMJE | ISS OBS T-001 | |||||||||
| Has Data Monitoring Committee | No | |||||||||
| U.S. FDA-regulated Product | Not Provided | |||||||||
| Plan to Share Data | Not Provided | |||||||||
| IPD Description | Not Provided | |||||||||
| Responsible Party | Barbara Ensoli, CNAIDS - Istituto Superiore di Sanita | |||||||||
| Study Sponsor ICMJE | Istituto Superiore di Sanità | |||||||||
| Collaborators ICMJE | Not Provided | |||||||||
| Investigators ICMJE |
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| PRS Account | Istituto Superiore di Sanità | |||||||||
| Verification Date | February 2010 | |||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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