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New treatment option for HIV Infections
Official title Accelerated ART Initiation for PWHIV Who Are Out of Care
ClinicalTrials.gov ID: NCT06374758
What this study is testing
What is bictegravir/emtricitabine/tenofovir alafenamide 50/200/25 mg?
bictegravir/emtricitabine/tenofovir alafenamide 50/200/25 mg is an investigational medicine, being studied as a potential treatment for hiv infections.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The main purpose of the study is to evaluate the effectiveness, of the ACCELERATE model of care to achieve HIV viral suppression at Week 24. The study will also assess the acceptability, appropriateness, feasibility, and sustainability of the ACCELERATE model of care.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- PLWH Participants must meet ALL the following 1. 18 years or older at the time of obtaining the informed consent
- Speaks English
- Able to give consent which includes the ability to understand and comply with study requirements and instructions as judged by clinic or study staff
- HIV-1 infection as documented by positive HIV test (positive laboratory HIV 1/2 Antibody differentiation assay or detectable HIV -1 RNA)
- Out of care, defined as not had a medical visit with an HIV care provider with prescribing privileges for ≥6 months AND not receiving ART for ≥1...
You likely can't join if
- PLWH Exclusion criteria: Participants who meet ANY of the following criteria are excluded
- Biktarvy (B/F/TAF) contraindicated or not recommended
- Known history of chronic kidney disease (creatinine clearance \<30 mL/min) using Cockcroft-Gault formula AND not on chronic dialysis
- Known history of allergy to B/F/TAF components
- Known history of intermediate-high level resistance to B/F/TAF components (score ≥30 on Stanford HIV Drug Resistance Algorithm) in the available...
- Concomitant use of contraindicated medications: using drug interaction database either Lexicomp® Drug Interactions (category X Avoid combination) or...
See the full eligibility criteria
- PLWH Participants must meet ALL the following 1. 18 years or older at the time of obtaining the informed consent
- Speaks English
- Able to give consent which includes the ability to understand and comply with study requirements and instructions as judged by clinic or study staff
- HIV-1 infection as documented by positive HIV test (positive laboratory HIV 1/2 Antibody differentiation assay or detectable HIV -1 RNA)
- Out of care, defined as not had a medical visit with an HIV care provider with prescribing privileges for ≥6 months AND not receiving ART for ≥1 month (by self-report) Site Staff Participants must meet ALL the following...
- HIV care providers, case managers, pharmacists, or administrators involved in administrative or clinical aspects of the intervention at participating sites
- Understand the long-term commitment to the study and be willing to participate
- Have adequate resources to complete assessments for the duration of the study
- PLWH Exclusion criteria: Participants who meet ANY of the following criteria are excluded
- Biktarvy (B/F/TAF) contraindicated or not recommended
- Known history of chronic kidney disease (creatinine clearance \<30 mL/min) using Cockcroft-Gault formula AND not on chronic dialysis
- Known history of allergy to B/F/TAF components
- Known history of intermediate-high level resistance to B/F/TAF components (score ≥30 on Stanford HIV Drug Resistance Algorithm) in the available medical record (not having a prior genotype or having M184V/I mutation is...
- Concomitant use of contraindicated medications: using drug interaction database either Lexicomp® Drug Interactions (category X Avoid combination) or Liverpool HIV Interactions Checker (category Do not Co-administer) or...
- Pregnant (by self-report) or planning to become pregnant while enrolled in the study
- HIV-2 infection
- PLWH who are breastfeeding and are not on ART or taking ART without virologic suppression since breastfeeding will not be recommended.
- Active opportunistic infections that would require a delay of ART as judged by the HIV care provider and based on current Guidelines for the Prevention and Treatment of Opportunistic Infections in Adults and Adolescents...
- Not residing in the state of Missouri at the time of the study or planning to relocate during the study period
- Incarcerated at the time of the study enrollment. Site Staff Exclusion criteria: 1) Moving practice location or job relocation within 1 year
The study team makes the final eligibility decision.
Where it's taking place
- Columbia, Missouri, United States
- Kansas City, Missouri, United States
- Springfield, Missouri, United States
- St Louis, Missouri, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Columbia, Missouri, United States; Kansas City, Missouri, United States; Springfield, Missouri, United States; St Louis, Missouri, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.