Long-term Follow-up of Participants From Studies Evaluating GSK HIV Vaccine

AIDS Clinical Trial

Official title:

Long-term Follow-up of Participants From Studies Evaluating the HIV Vaccine 732462

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01092611
• Other study ID #: 114083
• Secondary ID: 2009-018097-64
• Status: Completed
• Phase: Phase 1
• First received: March 22, 2010
• Last updated: March 1, 2018
• Start date: March 22, 2010
• Est. completion date: May 19, 2014

Study information

• Verified date: March 2018
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this long-term follow-up study is to assess the long-term health status of HIV-infected subjects who previously participated in GSK-sponsored trials evaluating the investigational HIV vaccine 732462. This study will provide additional data concerning the long-term benefits/risks associated with vaccination.

No vaccine will be administered during the study period. Vaccines were administered during the primary studies.

Description:

General information on the health of the subject and persistence of the cellular and humoral immune responses to study vaccination will be evaluated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 190
• Est. completion date: May 19, 2014
• Est. primary completion date: March 17, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

All subjects must satisfy ALL the following criteria at study entry:

• HIV-infected subject.

• Previous participation in a study evaluating GSK HIV vaccine 732462.

• Written informed consent obtained from the subject.

Exclusion Criteria:

The following criteria should be checked at the time of study entry. If ANY exclusion criterion applies, the subject must not be included in the study:

• Subjects who did not receive a complete vaccination course in previous studies.

Related Conditions & MeSH terms

• AIDS

Intervention

Procedure:
• Blood collection
Once a year after Visit 1 (during a maximum of 4 years). The samples will only be taken in conjunction with, and at the same time as, planned routine blood testing using the same needle-stick.

Biological:
• GSK HIV vaccine 732462
No vaccine will be administered during this long-term follow-up study. Vaccines were administered during the primary studies.

Locations

Country	Name	City	State
France	GSK Investigational Site	Bobigny
France	GSK Investigational Site	Créteil
France	GSK Investigational Site	Nantes
France	GSK Investigational Site	Paris
France	GSK Investigational Site	Paris
France	GSK Investigational Site	Paris Cedex 10
France	GSK Investigational Site	Paris Cedex 12
France	GSK Investigational Site	Paris Cedex 13
France	GSK Investigational Site	Paris cedex 15
France	GSK Investigational Site	Paris Cedex 20
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Bochum	Nordrhein-Westfalen
Germany	GSK Investigational Site	Erlangen	Bayern
Germany	GSK Investigational Site	Essen	Nordrhein-Westfalen
Germany	GSK Investigational Site	Freiburg	Baden-Wuerttemberg
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Koeln	Nordrhein-Westfalen
Germany	GSK Investigational Site	Muenchen	Bayern
Germany	GSK Investigational Site	Muenchen	Bayern
Germany	GSK Investigational Site	Muenchen	Bayern
Germany	GSK Investigational Site	Muenchen	Bayern
Spain	GSK Investigational Site	Badalona
Spain	GSK Investigational Site	Barcelona
Spain	GSK Investigational Site	Barcelona
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Móstoles, Madrid
Spain	GSK Investigational Site	Valencia
United States	GSK Investigational Site	Annandale	Virginia
United States	GSK Investigational Site	Bakersfield	California
United States	GSK Investigational Site	Camden	New Jersey
United States	GSK Investigational Site	Columbus	Ohio
United States	GSK Investigational Site	Dallas	Texas
United States	GSK Investigational Site	Fort Lauderdale	Florida
United States	GSK Investigational Site	Omaha	Nebraska
United States	GSK Investigational Site	Orlando	Florida
United States	GSK Investigational Site	Philadelphia	Pennsylvania
United States	GSK Investigational Site	Philadelphia	Pennsylvania
United States	GSK Investigational Site	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  France,  Germany,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of Anti-Retroviral Therapy (ART) (re)-initiation or ART modification, and reason (for ART modification)		Once a year after Visit 1 (during a maximum of 4 years)
Primary	CD4 count		Once a year after Visit 1 (during a maximum of 4 years)
Primary	Viral load (VL) and method of measurement		Once a year after Visit 1 (during a maximum of 4 years)
Primary	Occurrence of HIV disease progression		Once a year after Visit 1 (during a maximum of 4 years)
Primary	Occurrence of each separate defining condition for HIV-disease progression		Once a year after Visit 1 (during a maximum of 4 years)
Primary	Occurrence of specific clinical events and death		Once a year after Visit 1 (during a maximum of 4 years)
Primary	Occurrence of adverse events (AEs) or serious adverse events (SAEs) considered by the Investigator to be related to vaccination (performed in the preceding vaccination study)		Once a year after Visit 1 (during a maximum of 4 years)
Primary	Occurrence of potential immune-mediated diseases (pIMDs)		Once a year after Visit 1 (during a maximum of 4 years)
Primary	Occurrence of SAEs related to study participation		Once a year after Visit 1 (during a maximum of 4 years)
Secondary	Time between dose 1 and ART (re)-initiation or ART modification		Once a year after Visit 1 (during a maximum of 4 years)
Secondary	Time between dose 1 and CD4 count measurement		Once a year after Visit 1 (during a maximum of 4 years)
Secondary	Time between dose 1 and VL measurement		Once a year after Visit 1 (during a maximum of 4 years)
Secondary	Time between dose 1 and occurrence of HIV disease progression		Once a year after Visit 1 (during a maximum of 4 years)
Secondary	Time between dose 1 and occurrence of each separate defining condition for HIV-disease progression		Once a year after Visit 1 (during a maximum of 4 years)
Secondary	Antibody concentrations to vaccine antigens		Once a year after Visit 1 (during a maximum of 4 years)
Secondary	Cell-mediated immunity responses		Once a year after Visit 1 (during a maximum of 4 years)
Secondary	Additional exploratory immunogenicity endpoints (other T-cell immune markers or T-cell functional assays)		Once a year after Visit 1 (during a maximum of 4 years)

External Links

•   Results for study 114083 can be found on the GSK Clinical Study Register