HIV & Obesity
Conditions
Brief summary
Change from baseline in total body weight at week 28.
Detailed description
Change from baseline in total and subcutaneous fat, as measured by DXA at week 28., Changes from baseline to week 28 in markers of B-cell function, T-cell function, innate immunity, inflammation, gut microbiome composition, adipose tissue function, cholesterol and glucose metabolism and HIV RNA and HIV viral reservoir., The proportion of subjects in both arms not achieving ≥ 5% weight loss from baseline at week 16., Proportion with reported AE/AR, SAE/SAR, Change in health-related quality of life (QOL) at week 28., Change in PR interval (sec) on ECG from baseline to week 4 stratified by class of antiretrovirals
Interventions
Sponsors
University College Dublin
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in total body weight at week 28. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in total and subcutaneous fat, as measured by DXA at week 28., Changes from baseline to week 28 in markers of B-cell function, T-cell function, innate immunity, inflammation, gut microbiome composition, adipose tissue function, cholesterol and glucose metabolism and HIV RNA and HIV viral reservoir., The proportion of subjects in both arms not achieving ≥ 5% weight loss from baseline at week 16., Proportion with reported AE/AR, SAE/SAR, Change in health-related quality of life (QOL) at week 28., Change in PR interval (sec) on ECG from baseline to week 4 stratified by class of antiretrovirals | — |
Countries
Denmark, Ireland, Italy
Outcome results
None listed