Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-25 @ 11:56 PM
Study NCT ID:
NCT04653194
Status:
COMPLETED
Last Update Posted:
2024-02-08
First Post:
2020-11-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
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'
Sponsor:
Chelsea and Westminster NHS Foundation Trust
Organization:
Study Overview
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'
Status:
COMPLETED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BIC-T&T
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2019-003208-11 | EUDRACT_NUMBER | None | View |