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TERMINATED
NCT05289986
PHASE4

The Effect on Lipid Profile of Switching to Delstrigo in HIV Positive Patients

Sponsor: Chelsea and Westminster NHS Foundation Trust

View on ClinicalTrials.gov

Summary

This is an open label, randomised, two-arm switch study over 48 weeks in which virally suppressed participants on a stable combined ART regimen will be randomised (1:1) to an immediate switch to 3TC/TDF/DOR (immediate switch arm, N=30) for the duration of the 48-week study, or to maintaining their current cART followed by a switch to 3TC/TDF/DOR from week 24-48 (delayed switch arm, N=30). Participants will be monitored for the length of the study (48 weeks) plus a 30-day follow-up period. If patients withdraw or are withdrawn from the study treatment prematurely, an early termination visit (ETV) should occur within 30 days post withdrawal. The hypothesis of the study is that a switch to Delstrigo, which is a combination of tenofovir disoproxil, lamivudine and doravirine (TDF/3TC/DOR) has a favourable impact on lipid metabolism, glucose, weight, body composition and hepatic steatosis.

Official title: Switch From Stable cART Containing ABA/3TC or TAF/FTC Plus Dolutegravir or Bictegravir to TDF/3TC/Doravirine in People Living With HIV: Impact on Lipids, Body Composition, Insulin Sensitivity, Neuroendocrine Function and Inflammation Markers

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

19

Start Date

2023-11-21

Completion Date

2024-11-21

Last Updated

2026-05-28

Healthy Volunteers

No

Conditions

Interventions

DRUG

DELSTRIGO 100Mg-300Mg-300Mg Tablet

Delstrigo (300 mg of tenofovir disoproxil fumarate equivalent to 245 mg of tenofovir disoproxil, 300 mg of lamivudine and 100 mg of doravirine \- TDF/3TC/DOR)

Locations (2)

Chelsea and Westminster Hospital NHS Foundation Trust

London, London, United Kingdom

Mortimer Market Centres

London, London, United Kingdom