Back to resultsEfficacy of BIC/F/TAF Versus Standard of Care in the Treatment of New HIV Infection Diagnoses in the Context of 'Test and Treat' (BIC-T&T)
Primary Purpose
Human Immunodeficiency Virus
Status
Active
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
Biktarvy
Symtuza
Sponsored by
About this trial
This is an interventional treatment trial for Human Immunodeficiency Virus
Eligibility Criteria
Inclusion Criteria:
- 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;
Exclusion Criteria:
- 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.
- 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.
Sites / Locations
- Brighton and Sussex University Hospitals NHS Trust Lawson Unit Royal Sussex County Hospital
- Chelsea and Westminster Hospital NHS Foundation Trust
- Imperial College Healthcare NHS Trust
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Biktarvy treatment
Symtuza treatment
Arm Description
First-line HIV treatment of Biktarvy OD for 48 weeks
First-line HIV treatment of Symtuza OD for 48 weeks
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Adverse events occurrence
Frequency and severity of occurrence of adverse events in study participants
Viral resistance occurrence
Frequency of occurrence of confirmed viral resistance to study interventions
Full Information
NCT ID
NCT04653194
First Posted
November 27, 2020
Last Updated
April 18, 2023
Sponsor
Chelsea and Westminster NHS Foundation Trust
Collaborators
Imperial College London, Gilead Sciences
1. Study Identification
Unique Protocol Identification Number
NCT04653194
Brief 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'
Acronym
BIC-T&T
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'
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 30, 2020 (Actual)
Primary Completion Date
July 31, 2023 (Anticipated)
Study Completion Date
July 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chelsea and Westminster NHS Foundation Trust
Collaborators
Imperial College London, Gilead Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Immunodeficiency Virus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Open-label 1:1 non-inferiority randomised clinical trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Biktarvy treatment
Arm Type
Experimental
Arm Description
First-line HIV treatment of Biktarvy OD for 48 weeks
Arm Title
Symtuza treatment
Arm Type
Active Comparator
Arm Description
First-line HIV treatment of Symtuza OD for 48 weeks
Intervention Type
Drug
Intervention Name(s)
Biktarvy
Intervention Description
Combination single tablet anti-retroviral therapy: bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg
Intervention Type
Drug
Intervention Name(s)
Symtuza
Intervention Description
Combination single tablet anti-retroviral therapy: darunavir 800mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg
Primary Outcome Measure Information:
Title
Rate of HIV viral load response to first-line anti-retroviral treatment
Description
Change from baseline to week 12 in log10 HIV RNA level recorded in viral load assays.
Time Frame
Baseline to 12 weeks
Secondary Outcome Measure Information:
Title
Absolute efficacy in achieving viral suppression of newly diagnosed HIV infection.
Description
Proportion of participants achieving viral suppression at study visits as defined both by HIV copies < 20/ml and HIV copies < 50 ml
Time Frame
2 weeks, 4 weeks, 12 weeks, 24 weeks, 48 weeks
Title
Adverse events occurrence
Description
Frequency and severity of occurrence of adverse events in study participants
Time Frame
Baseline to 48 weeks
Title
Viral resistance occurrence
Description
Frequency of occurrence of confirmed viral resistance to study interventions
Time Frame
Baseline to 48 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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;
Exclusion Criteria:
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.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marta Boffito, MD PhD FRCP
Organizational Affiliation
Chelsea and Westminster NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brighton and Sussex University Hospitals NHS Trust Lawson Unit Royal Sussex County Hospital
City
Brighton
ZIP/Postal Code
BN2 5BE
Country
United Kingdom
Facility Name
Chelsea and Westminster Hospital NHS Foundation Trust
City
London
ZIP/Postal Code
SW10 9NH
Country
United Kingdom
Facility Name
Imperial College Healthcare NHS Trust
City
London
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy of BIC/F/TAF Versus Standard of Care in the Treatment of New HIV Infection Diagnoses in the Context of 'Test and Treat'
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