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Observational Study for the Evaluation of the Role of HIV-1 Tat Protein and Anti-Tat Immune Response In HIV Reservoir (ISS OBS T-005)

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ClinicalTrials.gov Identifier: NCT04263207
Recruitment Status : Recruiting
First Posted : February 10, 2020
Last Update Posted : February 10, 2021
Sponsor:
Information provided by (Responsible Party):
Barbara Ensoli, MD, PhD, Istituto Superiore di Sanità

Study Description
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Brief Summary:
A longitudinal observational study in HIV-infected subjects receiving cART addressed to explore the effect of the Tat protein and anti-Tat immunity on the formation and maintenance of HIV-1 virus reservoir.

Condition or disease Intervention/treatment
HIV/AIDS Other: No intervention

Detailed Description:

The study is designed as a longitudinal observational study addressed to identify the effects of Tat protein and humoral/cellular anti-Tat immune responses (induced in the natural infection or by Tat vaccination) in HIV-1 reservoir dynamics in blood of HIV infected patients receiving cART. HIV DNA data will be used for analyzing the decay dynamics.

The primary objective of the study is to determine the rate of decay of total HIV DNA in blood of anti-Tat antibody (Ab) positive versus anti-Tat Ab negative HIV patients receiving cART.

The secondary objectives of the study are to relate the HIV DNA decay data to:

  1. the persistence of anti-Tat humoral responses;
  2. biomarkers of HIV reservoir stability potentially affected by the Tat protein or anti-Tat immune responses, including: i) apoptotic/survival index of CD4+ T cells; ii) reactivation dynamics of latent HIV in resting CD4+ T cells upon exposure to Tat protein and/or activation stimuli; iii) cellular and humoral biomarkers relevant to inflammation and immune dysregulation.
Study Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Study for the Evaluation of the Role of HIV-1 Tat Protein and Anti-Tat Immune Response in Peripheral Blood HIV Reservoir Dynamics
Actual Study Start Date : February 4, 2020
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Groups and Cohorts
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Group/Cohort Intervention/treatment
anti-Tat Ab positive subjects Other: No intervention
No intervention
anti-Tat Ab negative subjects Other: No intervention
No intervention


Outcome Measures
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Primary Outcome Measures :
  1. HIV proviral DNA levels [ Time Frame: Baseline and through study completion, an average of 3 years ]
    Changes of total HIV-1 proviral DNA copies/1.000.000 CD4+ T-cells

  2. HIV plasma viremia [ Time Frame: Baseline and through study completion, an average of 3 years ]
    Changes of HIV plasma viral load (copies/mL)

  3. CD4+ and CD8+ T-cell levels [ Time Frame: Baseline and through study completion, an average of 3 years ]
    Changes of CD4+ and CD8+ T-cell counts (cells/microL)


Secondary Outcome Measures :
  1. lymphocytes subset apoptosis [ Time Frame: Baseline and through study completion, an average of 3 years ]
    Apoptotic index of isolated lymphocytes subsets

  2. Induction of replication of competent latent HIV-1 from resting CD4+ T-cell [ Time Frame: Baseline and through study completion, an average of 3 years ]
    Quantification of replication competent latent HIV-1 from isolated resting CD4+ T cells [TZM-bl cell based assay (TZA)]

  3. Inflammation/immune activation biomarkers [ Time Frame: Baseline and through study completion, an average of 3 years ]
    Plasma levels of inflammation and immune activation biomarkers

  4. Anti-Tat Ab isotypes [ Time Frame: Baseline and through study completion, an average of 3 years ]
    Anti-Tat humoral response in terms of anti-Tat IgM, IgG and IgA Ab


Biospecimen Retention:   Samples With DNA
Periferal blood mononuclear cells and plasma

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
HIV-1 infected adult subjects of either gender, ≥18 years old, under cART, with CD4+ T-cell count ≥250 cells/µL.
Criteria

Inclusion Criteria:

  1. Age ≥18 years
  2. Diagnosis of HIV-1 infection
  3. To be under cART treatment
  4. CD4+ T-cell count ≥250 cells/microliters
  5. Testing for anti-Tat Ab performed during pre-screening
  6. Signed informed consent

Exclusion Criteria:

1. Current therapy with immunomodulators or immunosuppressive drugs or chemotherapy for neoplastic disorders.

Contacts and Locations
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Information from the National Library of Medicine

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): NCT04263207


Contacts
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Contact: Barbara Ensoli, M.D. Ph.D +39 06 4990 ext 3209 barbara.ensoli@iss.it

Locations
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Italy
Infectious Dermatology STI Unit San Gallicano Dermatologic Institute , IRCCS Recruiting
Rome, Italy, 00144
Contact: Alessandra Latini, M.D.    +39 065266 ext 2805    alessandra.latini@ifo.gov.it   
Sponsors and Collaborators
Barbara Ensoli, MD, PhD
More Information
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Publications:

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Responsible Party: Barbara Ensoli, MD, PhD, Director, National HIV/AIDS Research Center (CNAIDS), Istituto Superiore di Sanità
ClinicalTrials.gov Identifier: NCT04263207    
Other Study ID Numbers: ISS OBS T-005
First Posted: February 10, 2020    Key Record Dates
Last Update Posted: February 10, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Barbara Ensoli, MD, PhD, Istituto Superiore di Sanità:
HIV/AIDS
Immune responses
Tat
HIV reservoire
Biomarkers
Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
 Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases