Evaluating efficacy and safety of switching HIV patients with limited further medicine choices from a particular type of HIV medicine (boosted protease inhibitor) to different type called fostemsavir
- Conditions
- Human Immunological virus HIV-1 patients currently virologically supressed and being treated with with boosted protease inhibitorsInfections and Infestations
- Registration Number
- ISRCTN10901519
- Lead Sponsor
- EAT ID
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 60
1. HIV-1 infected adults
2. Non-pregnant Individuals of Childbearing potential (IOCBP) must be confirmed by a negative serum human chorionic gonadotrophin (hCG) test at screening and a negative urine hCG test at Day 1 and each visit).
3. IOCBP should be receiving highly effective contraception.
4. On stable & suppressive cART with a VL <50 c/mL for 1 year allows one blip (50-200 c/mL) as long as resuppressed below 50 for 6 consecutive months prior to enrolment and with no major adherence issues.
5. Patients on bPI with no other potential switch to another approved regimen (except to Ibilizimuab if available) and are willing to switch to Fostemsavir from their boosted PI.
6. No significant laboratory abnormalities, medical/psychiatric conditions or alcohol/drug use considered a barrier to participation by investigators.
7. Willing to sign an informed consent and take part in the trial.
1. Age < 18 years.
2. Unable to take part in the trial according to the investigator opinion (example: unable to understand the trial information leaflet, unable to provide written consent, etc.)
3. History of being on a cART containing Fostemsavir.
4. HIV-1 subtype AE
5. Use of medications that are known to interact with Fostemsavir. Contraindications are given in appendix 3, and full information on drug-drug interactions is given in SmPC.
6. Hypersensitivity to active substance or excipient of Fostemsavir as listed in SmPC.
7. Ongoing malignancy other than cutaneous Kaposi’s sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma, or cervical or anal intraepithelial neoplasia; other localised malignancies require agreement between the investigator and the Trial medical monitor for inclusion of the patient prior to trial entry.
8. Known acute or chronic viral hepatitis including, but not limited to, A, B, or C. Chronic hepatitis B and history of hepatitis C (cured) are allowed.
9. Any investigational drug within 30 days prior to the trial drug administration
10. IOCBP who are pregnant, breastfeeding or plan to become pregnant or breastfeed during the trial
11. Patients with severe hepatic impairment (Class C) as determined by Child-Pugh classification
12. Unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, oesophagael or gastric varices, or persistent jaundice), cirrhosis, known biliary abnormalities (with the exception of Gilbert’s syndrome or asymptomatic gallstones).
13. History of congestive heart failure or congenital prolonged QT syndrome.
14. Confirmed QT value > 500 msec at Screening or Day 1.
15. Confirmed QTcF value > 470 msec for women and > 450 msec for men at Screening or Day 1
16. ALT>5 times the ULN, OR ALT>3xULN and bilirubin>1.5xULN (with >35% direct bilirubin).
17. Any other condition (including illicit drug use or alcohol abuse) or laboratory results which, in the investigator’s opinion, interfere with assessments or completion of the trial.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> To assess the proportion of patients with confirmed HIV viral load =50 copies/mL at week 48.<br> Confirmed VL is defined as two consecutive VL measurements confirmed to be = 50 copies/mL.<br> Patients should return within 2-4 weeks for a confirmatory VL.<br>
- Secondary Outcome Measures
Name Time Method