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A Roll-over Observational Study for the Extended Follow-up of the Volunteers of the ISS T-003 Trial (ISST-003EF-UP)

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ClinicalTrials.gov Identifier: NCT02712489
Recruitment Status : Completed
First Posted : March 18, 2016
Last Update Posted : December 29, 2016
Sponsor:
Collaborator:
Italian Ministry of Foreign Affairs - General Direction for Cooperation and Development
Information provided by (Responsible Party):
Barbara Ensoli, MD, PhD, Istituto Superiore di Sanità

Tracking Information
First Submitted Date March 4, 2016
First Posted Date March 18, 2016
Last Update Posted Date December 29, 2016
Study Start Date January 2015
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 14, 2016)
Presence of specific anti-Tat humoral immune response [ Time Frame: Through study completion, an average of 1 year ]
anti-Tat IgM, IgG, IgA antibodies
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02712489 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: March 14, 2016)
  • 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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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)
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.

Study Type Observational
Study Design Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood samples
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"
Condition HIV Infections
Intervention Other: No intervention
Study Groups/Cohorts No treatment
All patients that participated to the therapeutic phase II trial of the Tat vaccine "ISS T-003"
Intervention: Other: No intervention
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 14, 2016)
179
Original Actual Enrollment Same as current
Actual Study Completion Date October 2016
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries South Africa
Removed Location Countries  
 
Administrative Information
NCT Number NCT02712489
Other Study ID Numbers ISS T-003 EF-UP
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Barbara Ensoli, MD, PhD, Istituto Superiore di Sanità
Study Sponsor Barbara Ensoli, MD, PhD
Collaborators Italian Ministry of Foreign Affairs - General Direction for Cooperation and Development
Investigators Not Provided
PRS Account Istituto Superiore di Sanità
Verification Date December 2016