Observational Study of the Therapeutic Study of Recombinant HIV-1 TAT (ISS OBS T-001)
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| ClinicalTrials.gov Identifier: NCT01024595 |
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Recruitment Status :
Completed
First Posted : December 3, 2009
Last Update Posted : March 1, 2011
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Sponsor:
Istituto Superiore di Sanità
Information provided by:
Istituto Superiore di Sanità
| Tracking Information | ||||||||||
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| 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 |
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 |
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. |
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| Detailed Description | Not Provided | |||||||||
| Study Type | Observational | |||||||||
| Study Design | 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 | HIV Infection | |||||||||
| Intervention | 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 | Completed | |||||||||
| Actual Enrollment |
24 | |||||||||
| Original Actual Enrollment | Same as current | |||||||||
| Actual Study Completion Date | December 2010 | |||||||||
| Primary Completion Date | Not Provided | |||||||||
| Eligibility Criteria | Inclusion Criteria:
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| Sex/Gender |
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| 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 | |||||||||
| Investigators |
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| PRS Account | Istituto Superiore di Sanità | |||||||||
| Verification Date | February 2010 | |||||||||