BIKTARVY CLAMP
Research type
Research Study
Full title
The effect of Biktarvy (B/F/TAF) on whole-body insulin sensitivity, lipid and endocrine profile in healthy volunteers
IRAS ID
297761
Contact name
Marta Boffito
Contact email
Sponsor organisation
Chelsea & Westminster NHS Foundation Trust
Eudract number
2021-005369-42
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 6 months, 30 days
Research summary
Metabolic changes and weight increase commonly occur early in many people living with HIV shortly after antiretoviral treatment initiation is thought to be due in part to a reduction in basal metabolic rate following suppression of plasma viremia, improved appetite, lower inflammatory cytokine effects and a reduction in the rate of protein turnover. The association between insulin resistance and body shape changes and weight gain during therapy has not been established. Weight gain in the setting of HIV may not be exclusively related to glucose and/ or fat handling, but may also relate to alterations in endocrine function, therefore we proposed study to investigate changes in insulin resistance, lipid metabolism and complete endocrine profile in subject exposed to Biktarvy (B/F/TAF) to investigate the role all these different factors may potentially have in weight gain recently reported in clinical cohorts.
Primary objective of our study is to quantify the difference in change in insulin sensitivity with the administration of Biktarvy (B/F/TAF) HIV seronegative healthy volunteers. Duration of treatment with Biktarvy (B/F/TAF) will be 4 weeks. It is single centre study conducted in clinical research facility in Chelsea and Westminster NHS Hospital.REC name
London - Riverside Research Ethics Committee
REC reference
21/LO/0783
Date of REC Opinion
1 Dec 2021
REC opinion
Further Information Favourable Opinion