Human Immunodeficiency VirusPhase 3BIC-T&TNCT04653194
Efficacy of BIC/F/TAF Versus Standard of Care in the Treatment of New HIV Infection Diagnoses in the Context of 'Test and Treat'
A Phase 3 study testing Biktarvy and Symtuza in people with Human Immunodeficiency Virus, run by Chelsea and Westminster NHS Foundation Trust at 3 sites in United Kingdom.
Trial summary
The administration of combination antiretroviral therapy (cART) to HIV-infected patients has been associated with a dramatic reduction in AIDS-related morbidity and mortality. Time to cART start is currently approximately 2-4 weeks after diagnosis, mostly deferred for reasons of waiting for baseline blood test… 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 and Symtuza
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 30 Sep 2020to 31 Jul 2023
- Phase
- Phase 3
- 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
- Is male or female aged 18 years or over.
- Confirmed diagnosis of HIV-1 as per local clinic definition less than 14 days before day treatment is to be initiated.
- Is capable of giving informed consent.
- Is willing to comply with the protocol requirements
- 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 in Appendix 4 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 4) must be using an adequate method of contraception as listed in Appendix 4 to avoid pregnancy in their partner throughout the study and for a period of at least 12 weeks after the study;
Who cannot join
- Infected by HIV-2
- On PEP
- Use of medications that are know to interact with either treatment B or S
- Unstable health conditions that according to the opinion of the Investigator suggest the individual should not take part in the trial (including unstable liver diseases, possible opportunistic infections, etc)
- Women planning pregnancy or who are pregnant or breast feeding. (NB: See section 4.4; Withdrawal Criteria and Section 10.4; Collection and Follow up of Adverse Events if pregnancy does occur in a trial subject)
- Ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma, or cervical intraepithelial neoplasia; other localized malignancies require agreement between the investigator and the Study medical monitor for inclusion of the subject prior to randomisation.
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- Known acute or chronic viral hepatitis including, but not limited to, A, B, or C
- 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
3 sites in 1 country.
United Kingdom3 sites
Brighton and Sussex University Hospitals NHS Trust Lawson Unit Royal Sussex County Hospital
Brighton, BN2 5BE
Chelsea and Westminster Hospital NHS Foundation Trust
London, SW10 9NH
Imperial College Healthcare NHS Trust
London
About this study
The administration of combination antiretroviral therapy (cART) to HIV-infected patients has been associated with a dramatic reduction in AIDS-related morbidity and mortality. Time to cART start is currently approximately 2-4 weeks after diagnosis, mostly deferred for reasons of waiting for baseline blood test results; in particular HIV genotype, CD4 count, OI screen and logistics of a consultant clinical review. Whilst there is a clear rationale for this delay there is a risk of loss to follow-up as well as the potential risk of onward viral transmission. The balance between "readiness" to start ART against pragmatic and practical safe initiation of treatment needs to be tested using currently available safe potent antiretroviral agents in a head-to-head comparison study to allow careful rigorous comparisons of outcomes.
This study will recruit 36 newly diagnosed HIV patients to be started on treatment immediately upon diagnosis. This would optimally be within 7 days, for eligibility to the study up to 14 days will be permissible. Patients will be randomised to one of two open-label combination therapies known to be highly effective; Biktarvy or Symtuza. The patients will receive study treatment for 48 weeks. The two therapies will be compared by the change in HIV viral load from start of treatment to 12 weeks. Further clinical data will be recorded for the trial patients and exploratory investigations undertaken. As those recruited to the trial may not be representative of the full cohort of newly diagnosed HIV patients there will also be data collected on all newly diagnosed patients in a given period. This data will contribute to conclusions on the benefits and issues of implementing test and treat.
Read the detailed description
There will be an open-label two arm clinical trial with participants randomised to Biktarvy or Symtuza with equal probability. Study treatment will last for 48 weeks.
Baseline - Following confirmatory HIV testing potential participants will have a appointment with a study doctor. Full medical check and medical history undertaken. Patients will be offered opportunity to participate in the study. To avoid unnecessary visits and in line with the study aim of getting patients on treatment rapidly patients can consent on the same day that HIV diagnosis is confirmed to them. Treatment to be initiated following appointment in line with test and treat procedure. Samples will be taken (if not available from previous days) for all initial required tests.
Participants will be given baseline questionnaires that they can return on week 2 visit.
Week 1 call - Call to check drug adherence, adverse events and patient wellbeing.
Week 2 visit - Appointment with study doctor to review all results from initial tests. Following undertaken: viral load; vital signs; adverse events; adherence assessment.
Week 4, 12, 24, 48 Follow-up visits - Full medical review undertaken at each visit including safety blood tests.
Following undertaken: viral load; adverse events; adherence assessment; questionnaires; samples taken for secondary and exploratory objectives. Week 48 visit will be the end of study treatment period.
Follow-up visit - up to 30 days after the week 48 visit there will be a follow-up visit to complete final medical assessment and final adverse events reporting.
Samples will be collected from participants further to those required for stated objectives to be retained for future research into HIV infection.
We will also collect and clinical data cohort of data on all patients newly diagnosed with HIV during a set window.
Clinical data will be collected from their first year after diagnosis.
- Conditions
- Human Immunodeficiency Virus
- Being tested
- Biktarvy, Symtuza
- 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.
BiktarvyDrug
Combination single tablet anti-retroviral therapy: bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg
SymtuzaDrug
Combination single tablet anti-retroviral therapy: darunavir 800mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg
| Study group | Role | What they receive |
|---|---|---|
| Biktarvy treatment | Experimental | First-line HIV treatment of Biktarvy OD for 48 weeks Receives: Drug: Biktarvy |
| Symtuza treatment | Active comparator | First-line HIV treatment of Symtuza OD for 48 weeks Receives: Drug: Symtuza |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of HIV viral load response to first-line anti-retroviral treatment
Change from baseline to week 12 in log10 HIV RNA level recorded in viral load assays.
Measured: Baseline to 12 weeks
Secondary outcomes (3)
Absolute efficacy in achieving viral suppression of newly diagnosed HIV infection.
Proportion of participants achieving viral suppression at study visits as defined both by HIV copies < 20/ml and HIV copies < 50 ml
Measured: 2 weeks, 4 weeks, 12 weeks, 24 weeks, 48 weeks
Adverse events occurrence
Frequency and severity of occurrence of adverse events in study participants
Measured: Baseline to 48 weeks
Viral resistance occurrence
Frequency of occurrence of confirmed viral resistance to study interventions
Measured: Baseline to 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2020
- Study start30 Sep 2020
- Primary completion30 Jul 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open-label 1:1 non-inferiority randomised clinical trial
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chelsea and Westminster NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Imperial College London, Gilead Sciences
- Responsible party
- Sponsor
- Investigators
- Marta Boffito, MD PhD FRCP, Principal investigator, Chelsea and Westminster NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04653194
- Sponsor's protocol ID
- CRF002
- Other IDs
- 2019-003208-11, 2019
- Acronym
- BIC-T&T
- Status last verified
- Jan 2024
- First submitted
- 27 Nov 2020
- Last updated
- 8 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Khawaja AA, Whitlock G, Fidler S, Soler-Carracedo A, Henderson M, Taylor GP, Boffito M, Emerson M. Evaluation of the effect of 48 weeks of BIC/F/TAF and DRV/c/F/TAF on platelet function in the context of rapid ART start. HIV Res Clin Pract. 2025 Dec;26(1):2447015. doi: 10.1080/25787489.2024.2447015. Epub 2025 Jan 7.
PubMed 39763430
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of BIC/F/TAF Versus Standard of Care in the Treatment of New HIV Infection Diagnoses in the Context of 'Test and Treat'
- ClinicalTrials.gov ID
- NCT04653194
- Acronym / sponsor ID
- BIC-T&T / CRF002
- Conditions
- Human Immunodeficiency Virus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Chelsea and Westminster NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Imperial College London, Gilead Sciences
- Study start
- 30 Sep 2020 (actual)
- Primary completion
- 30 Jul 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 4 Dec 2020 (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.
The administration of combination antiretroviral therapy (cART) to HIV-infected patients has been associated with a dramatic reduction in AIDS-related morbidity and mortality. Time to cART start is currently approximately 2-4 weeks after diagnosis, mostly deferred for reasons of waiting for baseline blood test results; in particular HIV genotype, CD4 count, OI screen and logistics of a consultant clinical review. Whilst there is a clear rationale for this delay there is a risk of loss to follow-up as well as the potential risk of onward viral transmission. The balance between "readiness" to start ART against pragmatic and practical safe initiation of treatment needs to be tested using currently available safe potent antiretroviral agents in a head-to-head comparison study to allow careful rigorous comparisons of outcomes.
This study will recruit 36 newly diagnosed HIV patients to be started on treatment immediately upon diagnosis. This would optimally be within 7 days, for eligibility to the study up to 14 days will be permissible. Patients will be randomised to one of two open-label combination therapies known to be highly effective; Biktarvy or Symtuza. The patients will receive study treatment for 48 weeks. The two therapies will be compared by the change in HIV viral load from start of treatment to 12 weeks. Further clinical data will be recorded for the trial patients and exploratory investigations undertaken. As those recruited to the trial may not be representative of the full cohort of newly diagnosed HIV patients there will also be data collected on all newly diagnosed patients in a given period. This data will contribute to conclusions on the benefits and issues of implementing test and treat.
Detailed description
There will be an open-label two arm clinical trial with participants randomised to Biktarvy or Symtuza with equal probability. Study treatment will last for 48 weeks.
Baseline - Following confirmatory HIV testing potential participants will have a appointment with a study doctor. Full medical check and medical history undertaken. Patients will be offered opportunity to participate in the study. To avoid unnecessary visits and in line with the study aim of getting patients on treatment rapidly patients can consent on the same day that HIV diagnosis is confirmed to them. Treatment to be initiated following appointment in line with test and treat procedure. Samples will be taken (if not available from previous days) for all initial required tests.
Participants will be given baseline questionnaires that they can return on week 2 visit.
Week 1 call - Call to check drug adherence, adverse events and patient wellbeing.
Week 2 visit - Appointment with study doctor to review all results from initial tests. Following undertaken: viral load; vital signs; adverse events; adherence assessment.
Week 4, 12, 24, 48 Follow-up visits - Full medical review undertaken at each visit including safety blood tests.
Following undertaken: viral load; adverse events; adherence assessment; questionnaires; samples taken for secondary and exploratory objectives. Week 48 visit will be the end of study treatment period.
Follow-up visit - up to 30 days after the week 48 visit there will be a follow-up visit to complete final medical assessment and final adverse events reporting.
Samples will be collected from participants further to those required for stated objectives to be retained for future research into HIV infection.
We will also collect and clinical data cohort of data on all patients newly diagnosed with HIV during a set window.
Clinical data will be collected from their first year after diagnosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open-label 1:1 non-inferiority randomised clinical trial
| Arm | Type | Receives |
|---|---|---|
| Biktarvy treatment | Experimental | Drug: BiktarvyFirst-line HIV treatment of Biktarvy OD for 48 weeks |
| Symtuza treatment | Active comparator | Drug: SymtuzaFirst-line HIV treatment of Symtuza OD for 48 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Is male or female aged 18 years or over.
- Confirmed diagnosis of HIV-1 as per local clinic definition less than 14 days before day treatment is to be initiated.
- Is capable of giving informed consent.
- Is willing to comply with the protocol requirements
- A female may be eligible to enter and participate in the study if she:
Key exclusion criteria (9 listed)
- Infected by HIV-2
- On PEP
- Use of medications that are know to interact with either treatment B or S
- Unstable health conditions that according to the opinion of the Investigator suggest the individual should not take part in the trial (including unstable liver diseases, possible opportunistic infections, etc)
- Women planning pregnancy or who are pregnant or breast feeding. (NB: See section 4.4; Withdrawal Criteria and Section 10.4; Collection and Follow up of Adverse Events if pregnancy does occur in a trial subject)
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 |
|---|---|---|
| BiktarvyCombination single tablet anti-retroviral therapy: bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg | Drug | Biktarvy treatment |
| SymtuzaCombination single tablet anti-retroviral therapy: darunavir 800mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg | Drug | Symtuza treatment |
Primary outcome
Rate of HIV viral load response to first-line anti-retroviral treatment
Time frame: Baseline to 12 weeks
Change from baseline to week 12 in log10 HIV RNA level recorded in viral load assays.
3 secondary outcomes
Absolute efficacy in achieving viral suppression of newly diagnosed HIV infection.
Time frame: 2 weeks, 4 weeks, 12 weeks, 24 weeks, 48 weeks
Adverse events occurrence
Time frame: Baseline to 48 weeks
Viral resistance occurrence
Time frame: Baseline to 48 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2024.
- Derived from this study: PubMed 39763430Khawaja AA, Whitlock G, Fidler S, Soler-Carracedo A, Henderson M, Taylor GP, Boffito M, Emerson M. Evaluation of the effect of 48 weeks of BIC/F/TAF and DRV/c/F/TAF on platelet function in the context of rapid ART start. HIV Res Clin Pract. 2025 Dec;26(1):2447015. doi: 10.1080/25787489.2024.2447015. Epub 2025 Jan 7.
- 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, MD PhD FRCP principal investigator
Chelsea and Westminster NHS Foundation Trust
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Biktarvy and Symtuza in people with Human Immunodeficiency Virus, run by Chelsea and Westminster NHS Foundation Trust at 3 sites 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 8 inclusion and 9 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: finished, as of the sponsor's last update on 8 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Rate of HIV viral load response to first-line anti-retroviral treatment (time frame: Baseline to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04653194, which also lists 1 linked publication.
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 8 Feb 2024.