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Study of B/F/TAF in Participants Switching from CAB + RPV to B/F/TAF for HIV-1 Infection.
EU CTIS ID: 2023-506660-13-00
What this study is testing
To assess the safety of switching to bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in virologically suppressed participants unable/unwilling to continue on cabotegravir and rilpivirine (CAB+RPV) IM injections or wishing to switch to oral therapy through Week 12
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Participants 18 years of age or older and able to understand and give written informed consent.
- Total bilirubin ≤ 1.5 mg/dL (≤ 26 μmol/L), or normal direct bilirubin.
- No documented or suspected resistance to BIC, FTC, or tenofovir (TFV).
- Must be willing and able to comply with all study requirements.
- PWH or provider decision to switch off CAB+RPV IM injections due to intolerance, inconvenience, AEs, or willing to switch to (and intention to remain on) daily B/F/TAF.
- Currently virologically suppressed (HIV-1 RNA < 50 copies/mL) on CAB+RPV IM injections (Q2M).
You likely can't join if
- Positive serum pregnancy test (Appendix 11.5) or pregnant
- Current alcohol or substance use judged by the investigator to potentially interfere with participant study compliance.
- Serious illness requiring hospitalizations within 30 days prior to screening and during the screening period.
- Any other clinical condition or prior therapy that, in the opinion of the investigator, would make the participant unsuitable for the study or unable to comply with the dosing requirements.
- Known hypersensitivity to the study drug, its metabolites, or any formulation excipient
- History of B/F/TAF intolerance
See the full eligibility criteria
- Participants 18 years of age or older and able to understand and give written informed consent.
- Total bilirubin ≤ 1.5 mg/dL (≤ 26 μmol/L), or normal direct bilirubin.
- No documented or suspected resistance to BIC, FTC, or tenofovir (TFV).
- Must be willing and able to comply with all study requirements.
- PWH or provider decision to switch off CAB+RPV IM injections due to intolerance, inconvenience, AEs, or willing to switch to (and intention to remain on) daily B/F/TAF.
- Currently virologically suppressed (HIV-1 RNA < 50 copies/mL) on CAB+RPV IM injections (Q2M).
- Currently on CAB+RPV IM injections (Q2M) and received at least one dose of CAB+RPV IM injection; no missed CAB+RPV injections
- Ability to receive B/F/TAF up to 7 days prior to the next scheduled dose of CAB+RPV.
- Documented plasma HIV-1 RNA < 50 copies/mL during treatment for ≥ 6 months preceding the screening visit. a) Unconfirmed HIV-1 RNA ≥ 50 copies/mL (transient detectable viremia, or “blip”) prior to screening are acceptable. b) If the lower limit of detection of the local HIV-1 RNA assay is < 50 copies/mL (eg, < 20 copies/mL), the HIV-1 RNA level cannot exceed 50 copies/mL on 2 consecutive visits.
- Adequate renal function Estimated GFR ≥ 30 mL/min according to the Cockcroft-Gault formula {Cockcroft 1976} based on serum creatinine and actual body weight as measured at screening and upon admission, eg, a) Male: (140 – 𝐴𝑔𝑒 [𝑦𝑒𝑎𝑟𝑠]) ´ (𝑊𝑒𝑖𝑔ℎ𝑡 [𝑘𝑔]) 72 ´ (𝑆𝑒𝑟𝑢𝑚 𝐶𝑟𝑒𝑎𝑡𝑖𝑛𝑖𝑛𝑒 [𝑚𝑔/𝑑𝐿]) = 𝐶𝐿𝑐𝑟 (𝑚𝐿/𝑚𝑖𝑛) b) Female: (140 – 𝐴𝑔𝑒 [𝑦𝑒𝑎𝑟𝑠]) ´ (𝑊𝑒𝑖𝑔ℎ𝑡 [𝑘𝑔]) 72 ´ (𝑆𝑒𝑟𝑢𝑚 𝐶𝑟𝑒𝑎𝑡𝑖𝑛𝑖𝑛𝑒 [𝑚𝑔/𝑑𝐿]) × 0.85 = 𝐶𝐿𝑐𝑟 (𝑚𝐿/𝑚𝑖𝑛)
- Participants assigned female at birth of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception as described in Appendix 11.5.
- Hepatic transaminases (AST and ALT) ≤ 5 × upper limit of normal (ULN)
- Positive serum pregnancy test (Appendix 11.5) or pregnant
- Current alcohol or substance use judged by the investigator to potentially interfere with participant study compliance.
- Serious illness requiring hospitalizations within 30 days prior to screening and during the screening period.
- Any other clinical condition or prior therapy that, in the opinion of the investigator, would make the participant unsuitable for the study or unable to comply with the dosing requirements.
- Known hypersensitivity to the study drug, its metabolites, or any formulation excipient
- History of B/F/TAF intolerance
- History of previous INSTI virologic failure including CAB+RPV
- Requirement for ongoing therapy with any prohibited medications listed in local prescribing information for B/F/TAF starting within 30 days prior to screening until 30 days following the last dose of study drug.
- Have been treated within 3 months of study screening or expected to receive during the study immunosuppressant therapies or chemotherapeutic agents (eg, chronic [at least 4 weeks] systemic steroids, immunoglobulins, and other immune- or cytokine-based therapies).
- Participation in any other clinical study, including observational studies, without prior approval from the sponsor is prohibited while participating in this study
- Need for oral ART bridge or use of other ARV agents prior to starting B/F/TAF on Day 1
- Chronic hepatitis B virus (HBV) infection
The study team makes the final eligibility decision.
Where it's taking place
- Canada
- 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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canada; 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 EU CTIS; the study team decides eligibility.