Observational Study of the Therapeutic Study of Recombinant HIV-1 TAT (ISS OBS T-001)
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Purpose
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 |
|---|
|
HIV Infection |
| Study Type: | Observational |
| Study Design: | 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 |
- 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).
- 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
| Enrollment: | 24 |
| Study Start Date: | September 2007 |
| Study Completion Date: | December 2010 |
| Groups/Cohorts |
|---|
| Without treatment |
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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
Contacts and Locations| Italy | |
| San Raffaele Hospital | |
| Milan, Italy, 20127 | |
| S. Gallicano Hospital | |
| Rome, Italy, 00100 | |
| I.R.C.C.S. Spallanzani Hospital | |
| Rome, Italy, 00100 | |
| 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 |
More Information
Additional Information:
Publications:
| Responsible Party: | Barbara Ensoli, CNAIDS - Istituto Superiore di Sanita |
| ClinicalTrials.gov Identifier: | NCT01024595 History of Changes |
| Other Study ID Numbers: | ISS OBS T-001 |
| Study First Received: | December 2, 2009 |
| Last Updated: | February 28, 2011 |
| Health Authority: | Italy: The Italian Medicines Agency |
Keywords provided by Istituto Superiore di Sanita:
|
HIV Tat protein |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
ClinicalTrials.gov processed this record on May 21, 2013