Extended Follow-Up of the ISS T-003 Trial Volunteers (ISS T-003 EF-UP2020)

Study Overview
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Brief Summary
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A further extension of the follow-up of the volunteers of the ISS T-003 trial is being conducted in order to evaluate the persistence of vaccine immunogenicity as well as of the immunological and virological effects induced by the therapeutic immunization with Tat after about 10 years from vaccination.

Detailed Description
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The volunteers enrolled in the South African ISS T-003 trial (ClinicalTrials.gov NCT01513135; SANCTR: DOH-27-0211-3351) were recently enrolled in an observational study to extend the follow-up of the trial. The results of this study (ISS T-003 EF-UP, ClinicalTrials.gov NCT02712489; SANCTR: DOH-27-0615-4948) indicate the maintenance of anti-Tat Ab in a vast proposition of vaccinees. The new roll-over observational study (ISS T-003 EF-UP2020; SANCTR: DOH-27-072022-7347) is to be conducted to further extend the follow-up of the participants of the ISS T-003 trial in order to evaluate the persistence of vaccine immunogenicity as well as of the immunological and virological effects induced by the therapeutic immunization with Tat after about 10 years from vaccination. To this aim volunteers of the ISS T-003 study are included in a new 6-months study, with visits at weeks 0 and 24, during which the persistence and levels of anti-Tat antibodies (primary endpoint) and the CD4+ T-cell and HIV-1 plasma viraemia levels (secondary endpoint) will be evaluated. In addition, depending on the availability of residual specimens (PBMC, serum and plasma), further laboratory tests will be performed to investigate in-depth the immunological and virological profile of the volunteers. Clinical signs and symptoms of disease progression and AIDS-defining events will also be recorded.

Official Title
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A Roll-Over Observational Study for the Extended Follow-Up of the Volunteers of the ISS T-003 Trial (ISS T-003 EF-UP2020)

Conditions
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HIV Infections

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: previous participation in the ISS T-003 EF-UP study without withdrawal of consent; availability to participate in the ensuing extended follow-up study; signed informed consent. Exclusion Criteria: The absence of any of the above criteria will exclude the participants from the study.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Enrolled patients exiting the ISS T-003 EF-UP study<br>No intervention - No intervention is foreseen in this Observational Study | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti-Tat humoral Immune responses | Changes of anti-Tat serum antibody levels | Week 0 and week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CD4+ T cells levels | Evaluation of CD4+ T cell counts | Week 0 and week 24 | 
| HIV-1 plasma viremia | Evaluation of HIV-1 RNA plasma levels | Week 0 and week 24 | 
| HIV-1 reservoir | HIV-1 proviral DNA copies in blood | Week 0 and week 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, HAART-treated participants, Tat protein, Therapeutic immunization