Ask to take part

Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Martha Bullimore 02033152560
m.bullimore@nhs.net


Damon Foster 02033156825
damon.foster2@nhs.net


Study Location:

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Be Part of Research - Trial Details - The Effect on Lipid Profile of Switching to Delstrigo in HIV Positive Patients

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

Recruiting

Open to: ALL

Age: 18.0 - N/A

Medical Conditions


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


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If patients withdraw or are withdrawn from the study treatment prematurely, an early termination visit (ETV) should occur within 30 days post withdrawal.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.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Oct 2023 Jun 2024

INTERVENTIONAL

Intervention Type : DRUG
Intervention Description : 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)

Intervention Arm Group : delayed switch arm;immediate switch arm;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Chelsea and Westminster Hospital NHS Foundation Trust
    London
    SW10 9NH
  • Mortimer Market Centres
    London
    WC1E6JB


The study is sponsored by Chelsea and Westminster NHS Foundation Trust and is in collaboration with Merck Sharp & Dohme LLC.





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Read full details for Trial ID: NCT05289986
Last updated 07 February 2024

This page is to help you find out about a research study and if you may be able to take part

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