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IGF-1

Insulin-like Growth Factor 1, Somatomedin C

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Studies 92
Trials 100
Completed PHASE1 INTERVENTIONAL NCT04950530

The Effect of Biktarvy (B/F/TAF) on Whole-body Insulin Sensitivity, Lipid and Endocrine Profile in Healthy Volunteers

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

This study will investigate changes in insulin sensitivity, lipid metabolism and endocrine profile in HIV-negative subjects exposed to Biktarvy (B/F/TAF) compared to subject not exposed to B/F/TAF for 28 days.

Detailed Description

A randomised, crossover study investigating the difference in changes in insulin sensitivity (determined by peripheral glucose uptake using a euglycaemic clamp) with the administration of Biktarvy (B/F/TAF) compared to no B/F/TAF for 28 days in HIV seronegative healthy volunteers. Group 1: B/F/TAF tablet once daily for the first 28 days of the study. No treatment for the last 44 days of the study. Group 2: No treatment for the first 28 days of the study. B/F/TAF tablet once daily for the last 28 days of the study (day 44-72). Research bloods, endocrine profiles, weight and urine samples will be collected at baseline, as well as day 28, 44, and 72 to enable comparative analyses. Participants will be closely monitored whilst taking the study medications. Participants will exit the study 72 days post-randomisation, with a follow-up call 28 days after exiting.

Interventions

Name: BIKTARVY 50Mg-200Mg-25Mg Tablet
Type: DRUG
Description: A three-drug fixed dose combination tablet containing 50mg of bictegravir, 200mg of emtricitabine, and 25mg of tenofovir alafenamide taken once daily, orally

Primary Outcomes

Measure: Change in insulin sensitivity in participants from baseline to end of study between two crossover groups
TimeFrame: Baseline, day 28, 44, and 72 for both groups
Description: Change in insulin sensitivity will be determined by peripheral glucose uptake using a euglycaemic clamp.

Trial Information

NCT ID

NCT04950530

Status

Completed

Study Type

INTERVENTIONAL

Phases

PHASE1

Sponsor

Chelsea and Westminster NHS Foundation Trust

Last Updated

December 15, 2025