Study of B/F/TAF in Participants Switching from CAB + RPV to B/F/TAF for HIV-1 Infection.

Trial details

Who runs it

Gilead Sciences Inc.

Trial code

EU 2023-506660-13-00

Record updated

2025. február 4.

Original description

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 12Read full original descriptionShow less

A Phase 4 Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Oral B/F/TAF after Discontinuing Injectable CAB + RPV

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

Inclusion: 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).

Exclusion: 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; 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; Known hypersensitivity to the study drug, its metabolites, or any formulation excipient; History of B/F/TAF intolerance; Chronic hepatitis B virus (HBV) infection; 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.

EU CTIS 2023-506660-13-00