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Observational Study on Anti-Tat Immune Response in HIV-1-infected HAART-treated Adult Subjects (ISS OBS T-002)

This study has been completed.
Information provided by (Responsible Party):
Barbara Ensoli, MD, Istituto Superiore di Sanità Identifier:
First received: December 1, 2009
Last updated: March 3, 2016
Last verified: March 2016
The present study is designed as a prospective observational study directed at evaluating the frequency, magnitude, quality and persistence (primary endpoint) of the anti-Tat immune response in highly active antiretroviral therapy (HAART)-receiving HIV-1 infected individuals, and to prospectively evaluate the immunological, virological and clinical outcome of anti-Tat positive versus anti-Tat negative subjects under successful HAART (secondary endpoint), in order to determine the impact of anti-Tat immunity on HIV disease progression as well as the potential use of anti-Tat immune response assessment for the clinical and therapeutic management of HAART-treated infected patients. This survey provided important information for the design, planning and conduction of future therapeutic vaccine trials based on the HIV-1 Tat protein in HAART-treated patients.

HIV Infection

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Observational Study With Additional Diagnostic Procedures on Anti-Tat Immune Response in HIV-1-infected HAART-treated Adult Subjects

Resource links provided by NLM:

Further study details as provided by Barbara Ensoli, MD, Istituto Superiore di Sanità:

Primary Outcome Measures:
  • Assessment of anti-Tat antibodies in sera of subjects, and of the proliferative response (CFSE) and the production of γIFN, IL-4 and IL-2 (Elispot) by peripheral blood mononuclear cells (PBMC) in response to Tat.

Secondary Outcome Measures:
  • The decline of CD4+ T cell counts, the increase of HIV plasma viral load or the occurrence of AIDS-defining events were assessed to determine progression to disease.

Biospecimen Retention:   Samples With DNA
whole blood, serum, PBMCs

Enrollment: 142
Study Start Date: March 2008
Study Completion Date: February 2012

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Hiv-1-infected haart-treated adult subjects

Inclusion Criteria:

  • Diagnosis of HIV-1 infection
  • To be under successful HAART treatment with plasma viremia <50 copies/ml in the last 6 months prior to initiation of the study, without a history of virologic rebound
  • Known CD4+ T cells nadir
  • Age ≥ 18 years old
  • Signed informed consent

Exclusion Criteria:

  • Current therapy with immunomodulators or immunosuppressive drugs, or chemotherapy for neoplastic disorders
  • Concomitant treatment for HBV or HCV infection
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01024556

S.M. Goretti Hospital
Latina, Rome, Italy
General Hospital of Bari
Bari, Italy
Spedali Civili di Brescia
Brescia, Italy
General Hospital-University of Ferrara
Ferrara, Italy
A.M. Annunziata Hospital
Florence, Italy
L. Sacco Hospital
Milan, Italy
San Raffaele Hospital
Milan, Italy
General Hospital-University of Modena
Modena, Italy, 41100
San Gallicano Hospital
Rome, Italy
Amedeo di Savoia Hospital
Torino, Italy
Sponsors and Collaborators
Barbara Ensoli, MD
Principal Investigator: Roberto Esposito, MD Azienda Ospedaliero - Universitaria Policlinico di Modena, Modena, Italy
Principal Investigator: Giovanni Di Perri, MD Amedeo di Savoia Hospital, Turin, Italy
Principal Investigator: Adriano Lazzarin, MD San Raffaele Hospital - Milan, Italy
Principal Investigator: Massimo Galli, MD L. Sacco Hospital- Milan, Italy
Principal Investigator: Giampiero Carosi, MD "Spedali Civili" di Brescia , Brescia, Italy
Principal Investigator: Florio Ghinelli, MD Azienda Ospedaliero - Universitaria di Ferrara, Ferrara, Italy
Principal Investigator: Francesco Mazzotta, MD S. M. Annunziata Hospital, Florence, Italy
Principal Investigator: Guido Palamara, MD S. Gallicano Hospital- Rome, Italy
Principal Investigator: Fabrizio Soscia, MD S. M. Goretti Hospital- Latina, Italy
Principal Investigator: Giuseppe Pastore, MD "Ospedale Policlinico Consorziale"-Bari, Italy
  More Information

Additional Information:

Responsible Party: Barbara Ensoli, MD, PHD, Istituto Superiore di Sanità Identifier: NCT01024556     History of Changes
Other Study ID Numbers: ISS OBS T-002
Study First Received: December 1, 2009
Last Updated: March 3, 2016

Keywords provided by Barbara Ensoli, MD, Istituto Superiore di Sanità:

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases processed this record on September 21, 2017