Investigating if switching HIV patients from stable combined antiretroviral therapy to Delstrigo has fewer unwanted side effects e.g. weight gain, while being just as effective at maintaining an undetectable HIV viral load

Phase 4

• Conditions: Human immunodeficiency virus-1 (HIV-1); Infections and Infestations; Human immunodeficiency virus [HIV] disease

• Registration Number: ISRCTN42856592
• Lead Sponsor: Chelsea and Westminster Hospital NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-09-21
• Last Update Posted: 23 October 2023
• Study Completion: 2024-10-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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.
Men who are sexually active and have partners who are women of childbearing potential must be using an adequate method of contraception to avoid pregnancy (male condom or sterilisation confirmed prior to the participant’s entry into the study) as described in Appendix IV of the protocol

Exclusion Criteria

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
11. Individuals testing positive for HBcAb, but negative HBsAg/HBeAg, may be included in the trial
12. Individuals with positive anti-HCV results, but with HCV RNA not detected may be included in the trial
13. Pregnant or breastfeeding women, or individuals actively trying to conceive
14. History of osteoporosis or bone fractures/loss
15. Hypersensitivity to the active substance or to any of the excipients in tenofovir disoproxil fumarate, lamivudine and/or doravirine formulations

Study & Design

• Study Type: Interventional
• Study Design: Not specified