human immunodeficiency viruses (HIV)
Conditions
Brief summary
The primary endpoint is the amount of intact replication competent HIV sequences at W48 quantified by the fraction intact HIV viral sequences quantified by an intact proviral DNA assay, present in blood CD4 cells.
Detailed description
Quantification of viral markers as total and intact HIV DNA, and RNA transcripts at baseline, W48, W144 and W240., Full length sequencing of the virus at baseline, W144 and W240., Quantification of human pro-inflammatory mediators and markers of microbial translocation at baseline, W48, W144 and W240., Phenotype of innate immune cells at baseline W48, W144, W240., Function of immune cells at baseline,W144 and W240., Metabolic parameters at baseline, W24, W48, W72, W96, W120,W144, W186, W192, W216 and W240., Analysis of cardio-vascular risk at W240 based on risk stratification at D0, W48 and W144 in all or a subgroup of individuals.
Interventions
Sponsors
Universitair Ziekenhuis Gent, Universitair Ziekenhuis Gent
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the amount of intact replication competent HIV sequences at W48 quantified by the fraction intact HIV viral sequences quantified by an intact proviral DNA assay, present in blood CD4 cells. | — |
Secondary
| Measure | Time frame |
|---|---|
| Quantification of viral markers as total and intact HIV DNA, and RNA transcripts at baseline, W48, W144 and W240., Full length sequencing of the virus at baseline, W144 and W240., Quantification of human pro-inflammatory mediators and markers of microbial translocation at baseline, W48, W144 and W240., Phenotype of innate immune cells at baseline W48, W144, W240., Function of immune cells at baseline,W144 and W240., Metabolic parameters at baseline, W24, W48, W72, W96, W120,W144, W186, W192, W216 and W240., Analysis of cardio-vascular risk at W240 based on risk stratification at D0, W48 and W144 in all or a subgroup of individuals. | — |
Countries
Belgium
Outcome results
None listed