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)
|
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: NCT04263207 |
|
Recruitment Status :
Suspended
(Study halted prematurely due to the difficulties in dedicating the human resources necessary to conduct the study deriving from the COVID-19 pandemic, but potentially will resume)
First Posted : February 10, 2020
Last Update Posted : March 10, 2023
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
| Condition or disease | Intervention/treatment |
|---|---|
| HIV/AIDS | Other: No intervention |
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:
- the persistence of anti-Tat humoral responses;
- 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 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 2024 |
| Estimated Study Completion Date : | January 2024 |
| Group/Cohort | Intervention/treatment |
|---|---|
| anti-Tat Ab positive subjects |
Other: No intervention
No intervention |
| anti-Tat Ab negative subjects |
Other: No intervention
No intervention |
- 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
- HIV plasma viremia [ Time Frame: Baseline and through study completion, an average of 3 years ]Changes of HIV plasma viral load (copies/mL)
- 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)
- lymphocytes subset apoptosis [ Time Frame: Baseline and through study completion, an average of 3 years ]Apoptotic index of isolated lymphocytes subsets
- 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)]
- Inflammation/immune activation biomarkers [ Time Frame: Baseline and through study completion, an average of 3 years ]Plasma levels of inflammation and immune activation biomarkers
- 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
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, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Age ≥18 years
- Diagnosis of HIV-1 infection
- To be under cART treatment
- CD4+ T-cell count ≥250 cells/microliters
- Testing for anti-Tat Ab performed during pre-screening
- Signed informed consent
Exclusion Criteria:
1. Current therapy with immunomodulators or immunosuppressive drugs or chemotherapy for neoplastic disorders.
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
| Italy | |
| Infectious Dermatology STI Unit San Gallicano Dermatologic Institute , IRCCS | |
| Rome, Italy, 00144 | |
| 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: | March 10, 2023 |
| Last Verified: | March 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
|
HIV/AIDS Immune responses Tat HIV reservoire Biomarkers |
|
Acquired Immunodeficiency Syndrome HIV Infections Blood-Borne Infections Communicable Diseases Infections Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Lentivirus Infections |
Retroviridae Infections RNA Virus Infections Virus Diseases Slow Virus Diseases Genital Diseases Urogenital Diseases Immunologic Deficiency Syndromes Immune System Diseases |