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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)

This study has been completed.
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
ClinicalTrials.gov Identifier:
NCT02712489
First received: March 4, 2016
Last updated: December 28, 2016
Last verified: December 2016
  Purpose
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.

Condition Intervention
HIV Infections
Other: No intervention

Study Type: Observational
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)

Resource links provided by NLM:


Further study details as provided by Barbara Ensoli, MD, PhD, Istituto Superiore di Sanità:

Primary Outcome Measures:
  • Presence of specific anti-Tat humoral immune response [ Time Frame: Through study completion, an average of 1 year ]
    anti-Tat IgM, IgG, IgA antibodies


Secondary Outcome Measures:
  • 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
Blood samples

Enrollment: 179
Study Start Date: January 2015
Study Completion Date: October 2016
Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
No treatment
All patients that participated to the therapeutic phase II trial of the Tat vaccine "ISS T-003"
Other: No intervention

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

Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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"
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02712489

Locations
South Africa
Matsontso Mathebula Mecru Clinical Research Unit, Sefako Makgatho, Health Sciences University,
Medunsa, Gauteng, South Africa, 0204
Sponsors and Collaborators
Barbara Ensoli, MD, PhD
Italian Ministry of Foreign Affairs - General Direction for Cooperation and Development
  More Information

Additional Information:
Publications:

Responsible Party: Barbara Ensoli, MD, PhD, Director National Aids Center, Istituto Superiore di Sanità
ClinicalTrials.gov Identifier: NCT02712489     History of Changes
Other Study ID Numbers: ISS T-003 EF-UP
Study First Received: March 4, 2016
Last Updated: December 28, 2016

Keywords provided by Barbara Ensoli, MD, PhD, Istituto Superiore di Sanità:
HAART-treated participants
Tat
Therapeutic immunization

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases

ClinicalTrials.gov processed this record on May 25, 2017