Observational Study for the Evaluation of the Role of HIV-1 Tat Protein and Anti-Tat Immune Response In HIV Reservoir
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- STATUS
- Recruiting
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- participants needed
- 100
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- sponsor
- Barbara Ensoli, MD, PhD
Summary
A longitudinal observational study in HIV-infected subjects receiving cART addressed to
explore the effect of the Tat
Description
The study is designed as a longitudinal observational study addressed to identify the effects
of Tat
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 Tatprotein and/or activation stimuli; iii) cellular and humoral biomarkers relevant toinflammation and immune dysregulation.
Details
| Condition | HIV/AIDS |
|---|---|
| Age | 18years - 100years |
| Treatment | No intervention |
| Clinical Study Identifier | NCT04263207 |
| Sponsor | Barbara Ensoli, MD, PhD |
| Last Modified on | 19 February 2024 |
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
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