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

Recruiting

• Conditions: HIV Infections

• Registration Number: NCT05680948
• Lead Sponsor: Istituto Superiore di Sanità

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2022-12-05
• Status Verified: 2023-01
• Study First Submitted QC: 2023-01-09
• Study First Posted: 2023-01-11
• Study Start: 2023-01-25
• Last Update Submitted: 2023-02-23
• Last Update Posted: 2023-02-24
• Primary Completion: 2024-01
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 179

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.

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Exclusion Criteria

• The absence of any of the above criteria will exclude the participants from the study.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Anti-Tat humoral Immune responses	Week 0 and week 24	Changes of anti-Tat serum antibody levels

Secondary Outcome Measures

Name	Time	Method
CD4+ T cells levels	Week 0 and week 24	Evaluation of CD4+ T cell counts
HIV-1 plasma viremia	Week 0 and week 24	Evaluation of HIV-1 RNA plasma levels
HIV-1 reservoir	Week 0 and week 24	HIV-1 proviral DNA copies in blood

Trial Locations

Locations (1)

Mecru Clinical Research Unit (MeCRU); 🇿🇦 Medunsa, Gauteng, South Africa