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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:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
HIV Infections 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.


Study Design

Study Type : Observational
Actual Enrollment : 179 participants
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)
Study Start Date : January 2015
Primary Completion Date : April 2016
Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
No treatment
All patients that participated to the therapeutic phase II trial of the Tat vaccine "ISS T-003"
Other: No intervention


Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. CD4+ T cell counts [ Time Frame: Through study completion, an average of 1 year ]
  2. HIV-1 RNA Viral Load [ Time Frame: Through study completion, an average of 1 year ]

Biospecimen Retention:   Samples With DNA
Blood samples

Eligibility Criteria

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Posted: March 18, 2016    Key Record Dates
Last Update Posted: December 29, 2016
Last Verified: December 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