Long-term Follow-up of Participants From Studies Evaluating the HIV Vaccine 732462
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- AIDS
- Sponsor
- GlaxoSmithKline
- Enrollment
- 190
- Locations
- 1
- Primary Endpoint
- Occurrence of Anti-Retroviral Therapy (ART) (re)-initiation or ART modification, and reason (for ART modification)
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
Eligibility Criteria
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
- •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.
Outcomes
Primary Outcomes
Occurrence of Anti-Retroviral Therapy (ART) (re)-initiation or ART modification, and reason (for ART modification)
Time Frame: Once a year after Visit 1 (during a maximum of 4 years)
CD4 count
Time Frame: Once a year after Visit 1 (during a maximum of 4 years)
Viral load (VL) and method of measurement
Time Frame: Once a year after Visit 1 (during a maximum of 4 years)
Occurrence of HIV disease progression
Time Frame: 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)
Time Frame: Once a year after Visit 1 (during a maximum of 4 years)
Occurrence of each separate defining condition for HIV-disease progression
Time Frame: Once a year after Visit 1 (during a maximum of 4 years)
Occurrence of specific clinical events and death
Time Frame: Once a year after Visit 1 (during a maximum of 4 years)
Occurrence of potential immune-mediated diseases (pIMDs)
Time Frame: Once a year after Visit 1 (during a maximum of 4 years)
Occurrence of SAEs related to study participation
Time Frame: Once a year after Visit 1 (during a maximum of 4 years)
Secondary Outcomes
- 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))
- 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))
- 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))