Observational Study on Anti-Tat Immune Response in HIV-1-infected Asymptomatic Adult Subjects (ISS OBS T-003)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01029548 |
Recruitment Status
:
Completed
First Posted
: December 10, 2009
Last Update Posted
: March 4, 2016
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease |
---|
HIV Infections |
Study Type : | Observational |
Actual Enrollment : | 73 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Observational Study With Additional Diagnostic Procedures on Anti-Tat Immune Response in HIV-1-infected Asymptomatic Adult Subjects |
Study Start Date : | April 2008 |
Actual Study Completion Date : | May 2012 |

- Specific humoral and cellular immune responses to Tat will be monitored by assessing anti-Tat specific antibodies in sera, proliferative response (CFSE) and production of γIFN, IL-4 and IL-2 (Elispot) by peripheral blood mononuclear cells.
- The decline of CD4+ T cells count, the increase of the HIV plasma viral load or the occurrence of AIDS-defining events will be assessed to determine the progression to disease
Biospecimen Retention: Samples With DNA

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- To be clinically asymptomatic HIV-1 infected individuals with CD4+ T cell counts ≥400/μL
- To be naïve for antiretroviral therapy
- Levels of plasma viremia ≤100,000 copies/ml at baseline
- Age ≥ 18 years
- Signed informed consent
Exclusion Criteria:
- Current therapy with immunomodulators or immunosuppressive drugs or chemotherapy for neoplastic disorders
- Concomitant treatment for HBV or HCV infection

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01029548
Italy | |
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 | |
Giovanni Di Perri | |
Turin, Italy, 10149 |
Principal Investigator: | Francesco Mazzotta, MD | A.M. Annunziata Hospital Florence, Italy | |
Principal Investigator: | Giuseppe Pastore, MD | General Hospital of Bari | |
Principal Investigator: | Florio Ghinelli, MD | General Hospital-University of Ferrara | |
Principal Investigator: | Roberto Esposito, MD | General Hospital-University of Modena | |
Principal Investigator: | Massimo Galli, MD | L.Sacco Hospital - MI | |
Principal Investigator: | Fabrizio Soscia, MD | S.M. Goretti Hospital Latina | |
Principal Investigator: | Guido Palamara, MD | San Gallicano Hospital - Rome | |
Principal Investigator: | Adriano Lazzarin, MD | San Raffaele Hospital - Milan | |
Principal Investigator: | Giampiero Carosi, MD | Spedali Civili - Brescia | |
Principal Investigator: | Giovanni Di Perri, MD | Amedeo di Savoia Hospital - Turin |
Additional Information:
Publications of Results:
Other Publications:
Responsible Party: | Barbara Ensoli, MD, PhD, Istituto Superiore di Sanità |
ClinicalTrials.gov Identifier: | NCT01029548 History of Changes |
Other Study ID Numbers: |
ISS OBS T-003 |
First Posted: | December 10, 2009 Key Record Dates |
Last Update Posted: | March 4, 2016 |
Last Verified: | March 2016 |
Keywords provided by Barbara Ensoli, MD, Istituto Superiore di Sanità:
HIV Therapeutic Vaccine |
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 |