Efficacy, Tolerability and Acceptability of Biktarvy by TPLWH

Human Immunodeficiency Virus Clinical Trial

Official title: Efficacy, Tolerability and Acceptability of the Single Table Regimen (STR) Biktarvy® by Trans People Living With HIV (TPLWH)

Status Terminated

Clinical Trial Summary

This is a clinical trial for TPLWH (Trans People Living with HIV) who are stable on cART with an undetectable viral load or a detectable viral load but no resistance to NRTIs and InSTI. Following written consent and screening procedures, study subjects will undergo a switch (or will restart) of their combination antiretroviral therapy (cART) to Biktarvy. The goal of this research project is to recruit an understudied population into a controlled clinical trial aimed at optimizing TPLWH cART. This will be demonstrated by measuring viral load outcomes at regular intervals, with a focus on viral load results 48 weeks after Biktarvy initiation (primary outcome).

Clinical Trial Description

The goal of this research project is to recruit an understudied population into a controlled clinical trial aimed at optimizing TPLWH cART. This will be demonstrated by measuring viral load outcomes at regular intervals, with a focus on viral load results 48 weeks after Biktarvy initiation (primary outcome). A series of secondary endpoints will also be investigated to further demonstrate the benefits of Biktarvy use in a population that is known to experience a number of factors that correlate to poor cART adherence, higher viral loads, and worst clinical outcome.

This study is an Open-label, single arm, phase IV, multi-centre TPLWH who are stable on cART with an undetectable viral load or a detectable viral load but no resistance to NRTIs and InSTI. Each participant will act as his / her own control. The study duration is 96 weeks (primary endpoint will be at 48 weeks).

Screening and Baseline visit (Day 1):

Demographics, medical history and concomitant medications (CMs) review Physical examination, height, weight, waist circumference, vital signs (including temperature, blood pressure, heart rate and respiratory rate) Review of inclusion and exclusion criteria Written informed consent cART prescription Combination antiretroviral treatment initiation (treatment should commence within 28 days after the screening visit.

Urinalysis (macro-analysis and pregnancy test ) Hepatitis B/C testing (results from samples taken up to 14 days before baseline visit can be used). Chronic hepatitis B and history of hepatitis C (cured) are allowed Blood chemistry and haematology (results from samples taken up to 14 days before baseline visit can be used) Viral load Waist circumference at baseline and week 48 Questionnaires: Pittsburgh sleep questionnaire, Wellness thermometer, Barriers to Adherence questionnaire (only at baseline, week 24, 48, 96). GAD-7 and PHQ-9 at baseline and week 48.

Metabolics/metabolomics (plasma and urine) at baseline

Follow-up visits:

Week 4 (Day 22-36) Week 12 (Day 78-92) Week 24 (Day 162-176) Week 48 (Day 330-344) Week 60 (Day 426-440) Week 72 (Day 510-524) Week 96 (Day 670-684) cART prescription (Weeks 4, 12, 24, 48, 60, 72, and 96) Vital signs Weight, waist circumference Blood chemistry and haematology at local laboratory (see appendix 1) Urinalysis Viral load, CD4/CD8 counts (only at weeks 48 and 96 at local laboratory) Questionnaires: Pittsburgh sleep questionnaire, Wellness thermometer, Barriers to Adherence questionnaire (only at weeks 24, 48, 96). GAD-7 and PHQ-9 at baseline and week 48.

Concomitant medication check and adverse events review Metabolic and/or metabolomics changes (plasma and urine) following the switch to Biktarvy at weeks 24, 48 and 96.

Waist circumference at baseline and week 48

End of study visit (within 30 days after End of Treatment) OR Early Termination Visit (within 30 days of premature withdrawal) Vital signs Viral Load Blood chemistry and haematology Urinalysis Concomitant medication check and adverse events review ;

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Human Immunodeficiency Virus

• NCT number: NCT04944654
• Study type: Interventional
• Source: Chelsea and Westminster NHS Foundation Trust
• Status: Terminated
• Phase: Phase 4
• Start date: January 7, 2023
• Completion date: May 11, 2023