Clinical trial NCT02712489: A Roll-over Observational Study for the Extended Follow-up of the Volunteers of the ISS T-003 Trial
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Keywords: HAART-treated participants
Tat
Therapeutic immunization
Lead sponsor: Istituto Superiore di Sanità
Sponsor class: OTHER
Collaborators: name: Italian Ministry of Foreign Affairs - General Direction for Cooperation and Development
First posted: 2016-03-18
Enrollment: 179
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HAART-treated patients who participated to the therapeutic phase II trial of the Tat vaccine "ISS T-003"

Brief summary: A roll-over observational study (ISS T-003 EF-UP) is being conducted to extend the follow-up of the volunteers 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* previous participation in the ISS T-003 trial without withdrawal of consent;
* availability to participate in the extended follow-up study;
* signed informed consent.

Exclusion Criteria:

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

Primary outcomes:
measure: Presence of specific anti-Tat humoral immune response
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: CD4+ T cell counts
timeFrame: Through study completion, an average of 1 year
measure: HIV-1 RNA Viral Load
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Medunsa
country: South Africa
facility: Matsontso Mathebula Mecru Clinical Research Unit, Sefako Makgatho, Health Sciences University,
state: Gauteng
Study officials:
References:
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