Switch from stable combined antiretroviral therapy containing abacavir/lamivudine or emtricitabine/tenofovir alafenamide plus dolutegravir or bictegravir to tenofovir disoproxil fumarate/lamivudine/doravirine in people living with HIV: Impact on lipids, body composition, insulin sensitivity, neuroendocrine function and inflammation markers

Chelsea and Westminster Hospital NHS Foundation Trust0 sites60 target enrollmentSeptember 21, 2022

Overview

No summary available.

Registry

who.int

Start Date

September 21, 2022

End Date

October 31, 2024

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

Chelsea and Westminster Hospital NHS Foundation Trust

•1\. HIV\-1 infected, 18 years or older
•2\. On stable \& suppressive triple cART for at least 6 months
•3\. No evidence of resistance to DOR, 3TC or TDF
•4\. No laboratory abnormalities, medical/psychiatric conditions or alcohol/drug use considered a barrier to participation by investigators
•5\. Women who are of childbearing potential and sexually active need to use the hormonal contraceptive methods, associated with inhibition of ovulation, listed in the protocol and detailed in Appendix IV of the protocol:
•5\.1\. Implant
•5\.2\. Depot injection
•5\.3\. Intra\-uterine device or system
•5\.4\. Oral hormonal contraception
•A woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post\-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.

•1\. History of virological failure on a non\-nucleoside reverse transcriptase inhibitors (NNRTI) in the absence of a post\-failure genotypic resistance test proving the absence of resistance to DOR
•2\. History of virological failure on an 3TC and TDF in absence of a post\-failure genotypic resistance test proving the absence of resistance to DOR (INSTI mutations that will lead to the need of administering DOR twice daily are considered as resistance to DOR – and the participant will be considered NOT eligible)
•3\. Concomitant medication contra\-indicated with DOR, 3TC or TDF
•4\. Haemoglobin \<9 g/dl
•5\. Platelets \<80,000/mm³
•6\. Creatinine clearance \<50 ml/min
•7\. AST or ALT \=5N
•8\. Acute Hepatitis A infection
•9\. Concomitant DAA for anti\-HCV therapy
•10\. Known acute or chronic viral hepatitis B or C