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The Effect of Dolutegravir on Whole-body Insulin Sensitivity, Lipid and Endocrine Profile in Healthy Volunteers

NCT04771754 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2025-12-02

Study results available
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Summary

This study will investigate changes in insulin resistance, lipid metabolism and endocrine profile in HIV-negative subjects exposed to dolutegravir (an antiretroviral drug used in HIV treatment) in order to investigate the role all these different factors may potentially have in weight gain recently reported in clinical cohorts.

Conditions

  • HIV-1-infection on Healthy Volunteers

Interventions

DRUG

Dolutegravir

50 mg once daily orally

Sponsors & Collaborators

  • Chelsea and Westminster NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Ruth Bryne · Chelsea and Westminster Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-03-20
Primary Completion
2023-12-31
Completion
2024-01-10

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04771754 on ClinicalTrials.gov