Efficacy, Tolerability and Acceptability of Biktarvy by TPLWH

NCT04944654 | Terminated Phase 4

• 1 other identifier: CRF005
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Human Immunodeficiency Virus

Outcome Measures

Primary Outcomes (1)

• Measure of viral load

  Proportion of subject with HIV viral load \< 50 copies/mL from baseline to week 48

  48 weeks

Secondary Outcomes (6)

• Measure of viral load

  week 96

• Change in clinical outcomes

  week 96

• Drug-drug interactions

  week 96

• Changes in CD4 count and CD4:CD8 ratio

  week 48 and 96

• Patient questionnaires

  week 24, 48 and 96

Study Arms (1)

Assigned intervention

EXPERIMENTAL

Biktarvy OD for 96 weeks

Drug: BIKTARVY 50Mg-200Mg-25Mg Tablet

Interventions

BIKTARVY 50Mg-200Mg-25Mg Tablet DRUG

Combination single tablet anti-retroviral therapy: bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg

Assigned intervention

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Participant eligibility is based on self-representation of gender identity
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant self-identifies as transgender and/or has a current gender identity which differs from gender assigned at birth (includes all gender diverse people)
• Age \> 18 years
• HIV infection diagnosis at any time before study consent
• Willing to sign an informed consent and take part in the study
• On an antiretroviral regimen with an undetectable viral load or off an antiretroviral regimen with a detectable viral load (the cART can have been stopped for any clinical or personal reason; if on cART with a detectable viral load and no resistance to any of the component of Biktarvy, the patient is also eligible.
• A female may be eligible to enter and participate in the study if she:
• is of non-child-bearing potential defined as either post-menopausal (12 months of spontaneous amenorrhea and ≥ 45 years of age) or physically incapable of becoming pregnant with documented tubal ligation, hysterectomy or bilateral oophorectomy or,
• is of child-bearing potential with a negative pregnancy test at Screening (\& baseline visit) and agrees to use one of the methods of contraception to avoid pregnancy indicated during the study and for a period of 12 weeks after the study.
• Men who have partners who are women of childbearing potential (WOCBP - definition in Appendix 3) must be using an adequate method of contraception as listed the Protocol to avoid pregnancy in their partner throughout the study and for a period of at least 12 weeks after the study.

You may not qualify if:

• Age \< 18 years
• Unable to take part in the study according to the Investigator opinion (example: unable to understand the study information leaflet, unable to provide written consent, etc.)
• History of virological failure while on a cART containing NRTIs and InSTIs and development of resistance to NRTIs and InSTI
• Use of medications that are known to interact with Biktarvy. Contraindications given in appendix 4 and full information on drug-drug interactions given in SmPC.
• Hypersensitivity to active substance or excipient of Biktarvy as listed in SmPC.
• Women planning pregnancy or who are pregnant or breast feeding.
• 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
• Any investigational drug within 30 days prior to the trial drug administration
• 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.

Sponsors & Collaborators

• Chelsea and Westminster NHS Foundation Trust: lead
• Gilead Sciences: collaborator
• Imperial College London: collaborator

Study Sites (1)

Chelsea and Westminster Hospital NHS Foundation Trust

London, SW10 0XD, United Kingdom

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

bictegravir, emtricitabine, tenofovir alafenamide, drug combination

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Marta Boffito

  Chelsea and Westminster Hospital NHS Foundation Trust, London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open label, single arm study

Study Record Dates

• First Submitted: June 14, 2021
• First Posted: June 29, 2021
• Study Start: January 7, 2023
• Primary Completion: May 11, 2023
• Study Completion: May 11, 2023
• Last Updated: May 13, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)