Human Immunodeficiency VirusPhase 4NCT04944654
Efficacy, Tolerability and Acceptability of Biktarvy by TPLWH
A Phase 4 study testing BIKTARVY 50Mg-200Mg-25Mg Tablet in people with Human Immunodeficiency Virus, run by Chelsea and Westminster NHS Foundation Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Human Immunodeficiency Virus
- What is being tested?
- BIKTARVY 50Mg-200Mg-25Mg Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 7 Jan 2023to 11 May 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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.
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- 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 localized malignancies require agreement between the investigator and the Study medical monitor for inclusion of the subject prior to randomisation.
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Chelsea and Westminster Hospital NHS Foundation Trust
London, SW10 0XD
About this study
Official title: Efficacy, Tolerability and Acceptability of the Single Table Regimen (STR) Biktarvy® by Trans People Living With HIV (TPLWH)
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).
Read the detailed 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
- Conditions
- Human Immunodeficiency Virus
- Being tested
- BIKTARVY 50Mg-200Mg-25Mg Tablet
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIKTARVY 50Mg-200Mg-25Mg TabletDrug
Combination single tablet anti-retroviral therapy: bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg
| Study group | Role | What they receive |
|---|---|---|
| Assigned intervention | Experimental | Biktarvy OD for 96 weeks Receives: Drug: BIKTARVY 50Mg-200Mg-25Mg Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of viral load
Proportion of subject with HIV viral load < 50 copies/mL from baseline to week 48
Measured: 48 weeks
Secondary outcomes (6)
Measure of viral load
Proportion of subject with HIV viral load < 50 copies/mL from baseline to week 24 and 96.
Measured: week 96
Change in clinical outcomes
Occurrence of changes in clinical outcomes such as bone health, kidney function, cardiovascular risk, BMD, weight, BMI.
Measured: week 96
Drug-drug interactions
To evaluate the potential for drug-drug interactions in TPLWH who switch from their cART to Biktarvy® based on the University of Liverpool Drug interaction website or other sources of drug interaction knowledge, including prescribed drugs, hormones, over the counter medications and recreational drugs.
Measured: week 96
Changes in CD4 count and CD4:CD8 ratio
Changes in CD4 count and CD4:CD8 ratio during the course of the study
Measured: week 48 and 96
Patient questionnaires
Patient reported outcomes will be collected following the administration of specific questionnaires (including Wellness thermometer, sleep questionnaire, barriers to adherence questionnaire) in relation to the drug switch) at baseline and weeks 24, 48 and 96.Questionnaire such as GAD-7 and PHQ-9 will also be administered at baseline and at week 48.
Measured: week 24, 48 and 96
Measurement of waist circumference
To assess change in waist circumference at baseline and week 48.
Measured: week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2021
- Study start7 Jan 2023
- Primary completion11 May 2023
- Study completion11 May 2023
Why it stopped: Trial set up was delayed, funding support no longer available
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Immunodeficiency VirusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open label, single arm study
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chelsea and Westminster NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences, Imperial College London
- Responsible party
- Sponsor
- Investigators
- Marta Boffito, Principal investigator, Chelsea and Westminster Hospital NHS Foundation Trust, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04944654
- Sponsor's protocol ID
- CRF005
- Status last verified
- May 2024
- First submitted
- 14 Jun 2021
- Last updated
- 13 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy, Tolerability and Acceptability of the Single Table Regimen (STR) Biktarvy® by Trans People Living With HIV (TPLWH)
- ClinicalTrials.gov ID
- NCT04944654
- Acronym / sponsor ID
- CRF005
- Conditions
- Human Immunodeficiency Virus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Trial set up was delayed, funding support no longer available
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Chelsea and Westminster NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Gilead Sciences, Imperial College London
- Study start
- 7 Jan 2023 (actual)
- Primary completion
- 11 May 2023 (actual)
- Study completion
- 11 May 2023 (actual)
- First posted
- 29 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed 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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open label, single arm study
| Arm | Type | Receives |
|---|---|---|
| Assigned intervention | Experimental | Drug: BIKTARVY 50Mg-200Mg-25Mg TabletBiktarvy OD for 96 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BIKTARVY 50Mg-200Mg-25Mg TabletCombination single tablet anti-retroviral therapy: bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg | Drug | Assigned intervention |
Primary outcome
Measure of viral load
Time frame: 48 weeks
Proportion of subject with HIV viral load < 50 copies/mL from baseline to week 48
6 secondary outcomes
Measure of viral load
Time frame: week 96
Change in clinical outcomes
Time frame: week 96
Drug-drug interactions
Time frame: week 96
Changes in CD4 count and CD4:CD8 ratio
Time frame: week 48 and 96
Patient questionnaires
Time frame: week 24, 48 and 96
Measurement of waist circumference
Time frame: week 48
Results and safety
The study was stopped early (reason given: Trial set up was delayed, funding support no longer available). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marta Boffito principal investigator
Chelsea and Westminster Hospital NHS Foundation Trust, London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing BIKTARVY 50Mg-200Mg-25Mg Tablet in people with Human Immunodeficiency Virus, run by Chelsea and Westminster NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Trial set up was delayed, funding support no longer available). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure of viral load (time frame: 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2024.