Status:
COMPLETED
A Roll-over Observational Study for the Extended Follow-up of the Volunteers of the ISS T-003 Trial
Lead Sponsor:
Barbara Ensoli, MD, PhD
Collaborating Sponsors:
Italian Ministry of Foreign Affairs - General Direction for Cooperation and Development
Conditions:
HIV Infections
Eligibility:
All Genders
18-45 years
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 ...
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 e...
Eligibility Criteria
Inclusion
- 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
- The absence of any of the above criteria will exclude the participants from the study
Key Trial Info
Start Date :
January 1 2015
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2016
Estimated Enrollment :
179 Patients enrolled
Trial Details
Trial ID
NCT02712489
Start Date
January 1 2015
End Date
October 1 2016
Last Update
December 29 2016
Active Locations (1)
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1
Matsontso Mathebula Mecru Clinical Research Unit, Sefako Makgatho, Health Sciences University,
Medunsa, Gauteng, South Africa, 0204