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

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

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

Conditions
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AIDS

Intervention / Treatment
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* Procedure: Blood collection
* Biological: GSK HIV vaccine 732462


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Group A<br>Subjects who were administered the GSK HIV vaccine 732462 in primary studies and who accepted to participate in this study | Procedure: Blood collection<br>* 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.<br>Biological: GSK HIV vaccine 732462<br>* No vaccine will be administered during this long-term follow-up study. Vaccines were administered during the primary studies.<br>|
| Other: Group B<br>Subjects who were administered placebo in primary studies and who accepted to participate in this study | Procedure: Blood collection<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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long-term follow-up study, HIV-infected subjects, HIV therapeutic vaccine