ART-treated and ART-naïve HIV-infected adults (ART: anti-retroviral therapy) MedDRA version: 14.1 Level: PT Classification code 10020161 Term: HIV infection System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Code: F4co/AS01B
Pharmaceutical Form: Powder and solvent for solution for injection
Current Sponsor code: F4co
Other descriptive name: F4co
Concentration unit: µg microgram(s)
Concentration ty
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All subjects must satisfy ALL the following criteria at study entry: • HIV-infected subject • Previous participation in a study evaluating F4co/AS01B vaccine • Written informed consent obtained from the subject Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 229 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Subjects who did not receive a complete vaccination course in the previous study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To assess the health status of HIV-infected persons who have been previously enrolled in studies evaluating the F4co/AS01B vaccine • To assess CD4 count and viral load kinetics of HIV-infected persons who have been previously enrolled in studies evaluating the F4co/AS01B vaccine • To assess time to (re)initiation of ART of HIV-infected persons who have been previously enrolled in studies evaluating the F4co/AS01B vaccine • To assess the incidence of specific clinical events (cardiovascular, end stage renal and hepatic events, opportunistic infections, cancers) of HIV-infected persons who have been previously enrolled in studies evaluating the F4co/AS01B vaccine • To evaluate the safety of the F4co/AS01B vaccine and to check the safety of study participation;Secondary Objective: • To evaluate the HIV-specific cellular and humoral immune responses of HIV-infected persons who have been previously enrolled in studies evaluating the F4co/AS01B vaccine • To explore associations between health status and HIV-specific immune responses ;Primary end point(s): • Occurrence of ART (re)-initiation or ART modification, and reason (for ART modification) • CD4 count • VL and method of measurement • Occurrence of HIV disease progression • Occurrence of each separate defining condition for HIV-disease progression • Occurrence of specific clinical events and death and date • 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) • Occurrence of potential immune-mediated diseases (pIMDs) • Occurrence of SAEs related to study participation;Timepoint(s) of evaluation of this end point: Yearly | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Yearly;Secondary end point(s): •Time between dose 1 and ART (re)-initiation or ART modification •Time between dose 1 and CD4 count measurement •Time between dose 1 and viral load measurement •Time between dose 1 and occurrence of HIV disease progression •Time between dose 1 and occurrence of each separate defining condition for HIV-disease progression •Antibody concentrations to vaccine antigens •CMI responses (ICS) ?Breadth ?Intensity ?Cytokine co-expression profile •Additional exploratory immuno endpoints (other T-cell immune markers or T-cell functional assays) | — |
Countries
France, Germany, Spain, United States
Contacts
Public ContactClinical Disclosure Advisor
GlaxoSmithKline Biologicals
Outcome results
None listed