AIDS
Conditions
Keywords
long-term follow-up study, HIV-infected subjects, HIV therapeutic vaccine
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.
Detailed description
General information on the health of the subject and persistence of the cellular and humoral immune responses to study vaccination will be evaluated.
Interventions
PROCEDUREBlood 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.
BIOLOGICALGSK HIV vaccine 732462
No vaccine will be administered during this long-term follow-up study. Vaccines were administered during the primary studies.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of SAEs related to study participation | Once a year after Visit 1 (during a maximum of 4 years) |
| 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) |
Secondary
| Measure | Time frame |
|---|---|
| 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) |
| Antibody concentrations to vaccine antigens | Once a year after Visit 1 (during a maximum of 4 years) |
| Cell-mediated immunity responses | Once a year after Visit 1 (during a maximum of 4 years) |
| 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) |
| Time between dose 1 and ART (re)-initiation or ART modification | Once a year after Visit 1 (during a maximum of 4 years) |
Countries
France, Germany, Spain, United States
Outcome results
None listed