A Roll-over Observational Study for the Extended Follow-up of the Volunteers of the ISS T-003 Trial (ISST-003EF-UP)
|Study Design:||Time Perspective: Prospective|
|Official Title:||A Roll-over Observational Study for the Extended Follow-up of the Volunteers of the ISS T-003 Trial (ISS T-003 EF-UP)|
- Presence of specific anti-Tat humoral immune response [ Time Frame: Through study completion, an average of 1 year ]anti-Tat IgM, IgG, IgA antibodies
- CD4+ T cell counts [ Time Frame: Through study completion, an average of 1 year ]
- HIV-1 RNA Viral Load [ Time Frame: Through study completion, an average of 1 year ]
Biospecimen Retention: Samples With DNA
|Study Start Date:||January 2015|
|Study Completion Date:||October 2016|
|Primary Completion Date:||April 2016 (Final data collection date for primary outcome measure)|
All patients that participated to the therapeutic phase II trial of the Tat vaccine "ISS T-003"
|Other: No intervention|
An open label, non-interventional study roll-over study (ISS T-003 EF-UP) is being conducted to follow-up the persistence of vaccine humoral responses as well as of the immunological and virological effects induced by the therapeutic immunization with Tat.To this aim volunteers of the ISS T-003 study are included in one year study, with visits at weeks 0 and 24 and 54.
To assess the anti-Tat humoral immune response by the determination and titration of IgM, IgG and IgA anti-Tat antibodies (primary endpoint) and to evaluate CD4+ T cell counts and HIV-1 plasma viraemia (as secondary endpoint).
In addition, depending on the availability of residual specimens (PBMC, serum and plasma), further laboratory tests (i.e. HIV DNA copies in blood) to investigate in-depth the immunological and virological profile of the volunteers is being performed.
Physical examination is being performed to monitor the clinical status of the volunteers and to record the appearance of clinical signs and symptoms of disease progression as well as AIDS-defining events, data or records related to ARV treatment compliance. Pregnancy onset for female participants will also be recorded.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02712489
|Matsontso Mathebula Mecru Clinical Research Unit, Sefako Makgatho, Health Sciences University,|
|Medunsa, Gauteng, South Africa, 0204|