Status:
TERMINATED
The Effect on Lipid Profile of Switching to Delstrigo in HIV Positive Patients
Lead Sponsor:
Chelsea and Westminster NHS Foundation Trust
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Hiv
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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/T...
Detailed Description
Open-label, 2 arm, multi-centre, non-inferiority switch study. Sample size: 60 participants Participant population: HIV-1 infected patients on stable and suppressive triple cART. IMP: Delstrigo (30...
Eligibility Criteria
Inclusion
- HIV-1 infected, 18 years or older
- On stable \& suppressive triple cART containing ABA/3TC or TAF/FTC plus dolutegravir or bictegravir for at least 6 months
- No evidence of resistance to TDF, 3TC, or DOR
- No laboratory abnormalities, medical/psychiatric conditions or alcohol/drug use considered a barrier to participation by investigators
- 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:
- Implant
- Depot injection
- Intra-uterine device or system
- 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 subject's entry into the study)
Exclusion
- History of virological failure on an NNRTI in absence of a post-failure genotypic resistance test proving absence of resistance to DOR
- Concomitant medication contra-indicated with TDF, FTC or DOR
- Haemoglobin \<9 g/dL
- Platelets \<80,000/mm3
- Creatinine clearance \<50 mL/min
- AST or ALT ≥5N
- Acute Hepatitis A infection.
- Concomitant DAA for anti-HCV therapy
- Known acute or chronic viral hepatitis B or C.
- o Individuals with positive anti-HCV results, but with HCV RNA not detected may be included on the trial.
- Pregnant or breastfeeding women, or individuals actively trying to conceive
- History of osteoporosis or bone fractures/loss
- Hypersensitivity to the active substance or to any of the excipients in tenofovir disoproxil fumarate, lamivudine and/or doravirine formulations
- Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption.
Key Trial Info
Start Date :
November 21 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 21 2024
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT05289986
Start Date
November 21 2023
End Date
November 21 2024
Last Update
December 10 2024
Active Locations (2)
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1
Chelsea and Westminster Hospital NHS Foundation Trust
London, London, United Kingdom, SW10 9NH
2
Mortimer Market Centres
London, London, United Kingdom, WC1E6JB