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

December 28, 2016 updated by: Barbara Ensoli, MD, PhD

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

179

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Africa
    • Gauteng
      • Medunsa, Gauteng, South Africa, 0204
        • Matsontso Mathebula Mecru Clinical Research Unit, Sefako Makgatho, Health Sciences University,

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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"

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of specific anti-Tat humoral immune response
Time Frame: Through study completion, an average of 1 year
anti-Tat IgM, IgG, IgA antibodies
Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
CD4+ T cell counts
Time Frame: Through study completion, an average of 1 year
Through study completion, an average of 1 year
HIV-1 RNA Viral Load
Time Frame: Through study completion, an average of 1 year
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Barbara Ensoli, MD, PhD

Collaborators

Italian Ministry of Foreign Affairs - General Direction for Cooperation and Development

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

March 4, 2016

First Submitted That Met QC Criteria

March 14, 2016

First Posted (Estimate)

March 18, 2016

Study Record Updates

Last Update Posted (Estimate)

December 29, 2016

Last Update Submitted That Met QC Criteria

December 28, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ISS T-003 EF-UP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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