Long-term Follow-up of Participants From Studies Evaluating GSK HIV Vaccine
2 other identifiers
interventional
190
4 countries
41
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Mar 2010
Longer than P75 for phase_1
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 22, 2010
CompletedStudy Start
First participant enrolled
March 22, 2010
CompletedFirst Posted
Study publicly available on registry
March 25, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 17, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 19, 2014
CompletedMarch 2, 2018
March 1, 2018
4 years
March 22, 2010
March 1, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (9)
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)
CD4 count
Once a year after Visit 1 (during a maximum of 4 years)
Viral load (VL) and method of measurement
Once a year after Visit 1 (during a maximum of 4 years)
Occurrence of HIV disease progression
Once a year after Visit 1 (during a maximum of 4 years)
Occurrence of each separate defining condition for HIV-disease progression
Once a year after Visit 1 (during a maximum of 4 years)
Occurrence of specific clinical events and death
Once a year after Visit 1 (during a maximum of 4 years)
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)
Occurrence of potential immune-mediated diseases (pIMDs)
Once a year after Visit 1 (during a maximum of 4 years)
Occurrence of SAEs related to study participation
Once a year after Visit 1 (during a maximum of 4 years)
Secondary Outcomes (8)
Time between dose 1 and ART (re)-initiation or ART modification
Once a year after Visit 1 (during a maximum of 4 years)
Time between dose 1 and CD4 count measurement
Once a year after Visit 1 (during a maximum of 4 years)
Time between dose 1 and VL measurement
Once a year after Visit 1 (during a maximum of 4 years)
Time between dose 1 and occurrence of HIV disease progression
Once a year after Visit 1 (during a maximum of 4 years)
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)
- +3 more secondary outcomes
Study Arms (2)
Group A
OTHERSubjects who were administered the GSK HIV vaccine 732462 in primary studies and who accepted to participate in this study
Group B
OTHERSubjects who were administered placebo in primary studies and who accepted to participate in this study
Interventions
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.
No vaccine will be administered during this long-term follow-up study. Vaccines were administered during the primary studies.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Subjects who did not receive a complete vaccination course in previous studies.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (41)
GSK Investigational Site
Bakersfield, California, 93301, United States
GSK Investigational Site
Fort Lauderdale, Florida, 33308, United States
GSK Investigational Site
Orlando, Florida, 32803, United States
GSK Investigational Site
Omaha, Nebraska, 68198, United States
GSK Investigational Site
Camden, New Jersey, 08103, United States
GSK Investigational Site
Columbus, Ohio, 43210, United States
GSK Investigational Site
Philadelphia, Pennsylvania, 19104, United States
GSK Investigational Site
Philadelphia, Pennsylvania, 19107, United States
GSK Investigational Site
Dallas, Texas, 75246, United States
GSK Investigational Site
Annandale, Virginia, 22003, United States
GSK Investigational Site
Seattle, Washington, 98104, United States
GSK Investigational Site
Bobigny, 93009, France
GSK Investigational Site
Créteil, 94010, France
GSK Investigational Site
Nantes, 44093, France
GSK Investigational Site
Paris, 75018, France
GSK Investigational Site
Paris, 75475, France
GSK Investigational Site
Paris, 75571, France
GSK Investigational Site
Paris, 75651, France
GSK Investigational Site
Paris, 75679, France
GSK Investigational Site
Paris, 75908, France
GSK Investigational Site
Paris, 75970, France
GSK Investigational Site
Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany
GSK Investigational Site
Erlangen, Bavaria, 91054, Germany
GSK Investigational Site
Munich, Bavaria, 80331, Germany
GSK Investigational Site
Munich, Bavaria, 80335, Germany
GSK Investigational Site
Munich, Bavaria, 80801, Germany
GSK Investigational Site
Munich, Bavaria, 81371, Germany
GSK Investigational Site
Bochum, North Rhine-Westphalia, 44791, Germany
GSK Investigational Site
Cologne, North Rhine-Westphalia, 50937, Germany
GSK Investigational Site
Essen, North Rhine-Westphalia, 45122, Germany
GSK Investigational Site
Berlin, 12157, Germany
GSK Investigational Site
Berlin, 13353, Germany
GSK Investigational Site
Hamburg, 20095, Germany
GSK Investigational Site
Hamburg, 20246, Germany
GSK Investigational Site
Badalona, 08916, Spain
GSK Investigational Site
Barcelona, 08036, Spain
GSK Investigational Site
Barcelona, 08907, Spain
GSK Investigational Site
Madrid, 28034, Spain
GSK Investigational Site
Madrid, 28041, Spain
GSK Investigational Site
Móstoles, Madrid, 28935, Spain
GSK Investigational Site
Valencia, 46014, Spain
Related Publications (1)
Harrer T, Dinges W, Roman F; TH-HIV-011 study group. Long-term follow-up of HIV-1-infected adults who received the F4/AS01B HIV-1 vaccine candidate in two randomised controlled trials. Vaccine. 2018 May 3;36(19):2683-2686. doi: 10.1016/j.vaccine.2018.03.043. Epub 2018 Mar 30.
PMID: 29606517DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 22, 2010
First Posted
March 25, 2010
Study Start
March 22, 2010
Primary Completion
March 17, 2014
Study Completion
May 19, 2014
Last Updated
March 2, 2018
Record last verified: 2018-03