Meta-D
Research type
Research Study
Full 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
IRAS ID
1004705
Contact name
Mark Nelson
Contact email
Sponsor organisation
Chelsea and Westminster Hospital NHS Foundation Trust
Eudract number
2021-006507-15
ISRCTN Number
ISRCTN42856592
Clinicaltrials.gov Identifier
Research summary
Combination antiretroviral therapy (cART) HIV treatments are associated with increased quality of life, and a normalisation of life expectancy in people living with HIV. However, long-term use of certain cARTs can lead to side-effects, such as weight-gain, through exposure to drug-related toxicity.
This study investigates if a switch to Delstrigo (a combination tenofovir disoproxil, lamivudine and doravirine) might result in improvement or stabilisation of metabolic parameters (lipids and weight) , while providing the same effectiveness and quality of care as existing treatments for HIV.
This will be a multicentre trial of 60 participants total. Eligible participants are people living with HIV on stable and suppressive cART. The trial will last 48 weeks plus a screening visit and a follow up visit. This includes 7 visits to the clinic and 1 telephone visit. Blood and urine samples will be taken, as well as a DEXA scan and CAP Fibroscan to measure body fat and liver function.REC name
London - Hampstead Research Ethics Committee
REC reference
22/LO/0468
Date of REC Opinion
31 Aug 2022
REC opinion
Further Information Favourable Opinion