At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 16 enrolled
Drug / intervention
Dolutegravirdrug
Likely dose
Dolutegravir 50 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
The Effect of Dolutegravir on Whole-body Insulin Sensitivity, Lipid and Endocrine Profile in Healthy Volunteers
In Brief
A Phase 1 clinical trial evaluating Dolutegravir for HIV-1-infection on Healthy Volunteers. Completed, enrolled 16 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV-1-infection on Healthy Volunteers
CountriesUnited Kingdom
Collaborators--
Timeline
Phase 1CompletedFinished
20222023202420252026
First PostedFeb 2021
Enrollment StartMar 2022
Primary CompletionDec 2023
Study CompletionJan 2024
TodayJul 2026
First PostedFeb 25, 2021
Enrollment StartMar 20, 2022
Primary CompletionDec 31, 2023
Study CompletionJan 10, 2024
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 5.4 years ago
Interventions
Dolutegravirdrug
50 mg once daily orally