Observational Study of the Therapeutic Study of Recombinant HIV-1 TAT
NCT ID: NCT01024595
Last Updated: 2011-03-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
24 participants
OBSERVATIONAL
2007-09-30
2010-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Observational Study of the Preventive Trial With HIV-1 Tat Protein
NCT01024764
Phase I Safety and Immunogenicity Preventative Vaccine Trial Based on Recombinant Tat Protein
NCT00529698
Phase I Safety and Immunogenicity Vaccine Trial Against HIV/AIDS
NCT00505401
Immunogenicity and Safety Trial of the HIV-1 Tat Vaccine
NCT00751595
A Phase Il of a Therapeutic, Recombinant, Biologically Active HIV-1 Tat Protein Vaccine in HIV-Infected, Anti-Tat Negative, ARV-Treated Adult Volunteers
NCT01513135
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Without treatment
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
18 Years
50 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Istituto Superiore di SanitÃ
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
CNAIDS - Istituto Superiore di Sanita
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Adriano Lazzarin, MD
Role: PRINCIPAL_INVESTIGATOR
San Raffaele Hospital - Milan, Italy
Aldo Di Carlo, MD
Role: PRINCIPAL_INVESTIGATOR
S. Gallicano Hospital- Rome, Italy
Pasquale Narciso, MD
Role: PRINCIPAL_INVESTIGATOR
I.R.C.C.S. Spallanzani Hospital, Rome
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
San Raffaele Hospital
Milan, , Italy
I.R.C.C.S. Spallanzani Hospital
Rome, , Italy
S. Gallicano Hospital
Rome, , Italy
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Ensoli B, Barillari G, Salahuddin SZ, Gallo RC, Wong-Staal F. Tat protein of HIV-1 stimulates growth of cells derived from Kaposi's sarcoma lesions of AIDS patients. Nature. 1990 May 3;345(6270):84-6. doi: 10.1038/345084a0.
Ensoli B, Buonaguro L, Barillari G, Fiorelli V, Gendelman R, Morgan RA, Wingfield P, Gallo RC. Release, uptake, and effects of extracellular human immunodeficiency virus type 1 Tat protein on cell growth and viral transactivation. J Virol. 1993 Jan;67(1):277-87. doi: 10.1128/JVI.67.1.277-287.1993.
Ensoli B, Gendelman R, Markham P, Fiorelli V, Colombini S, Raffeld M, Cafaro A, Chang HK, Brady JN, Gallo RC. Synergy between basic fibroblast growth factor and HIV-1 Tat protein in induction of Kaposi's sarcoma. Nature. 1994 Oct 20;371(6499):674-80. doi: 10.1038/371674a0.
Ensoli B, Fiorelli V, Ensoli F, Cafaro A, Titti F, Butto S, Monini P, Magnani M, Caputo A, Garaci E. Candidate HIV-1 Tat vaccine development: from basic science to clinical trials. AIDS. 2006 Nov 28;20(18):2245-61. doi: 10.1097/QAD.0b013e3280112cd1. No abstract available.
Related Links
Access external resources that provide additional context or updates about the study.
Related Info
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ISS OBS T-001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.