Ignite Creation Date:
2024-05-06 @ 3:30 PM
Last Modification Date:
2024-10-26 @ 1:50 PM
Study NCT ID:
NCT04653194
Status:
COMPLETED
Last Update Posted:
2024-02-08
First Post:
2020-11-27
Brief Title:
Efficacy of BICFTAF 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:
Chelsea and Westminster NHS Foundation Trust
Study Overview
Official Title:
Efficacy of BICFTAF 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-TT
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:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2019-003208-11 | EUDRACT_NUMBER | None | None |