Study of B/F/TAF in Participants Switching from CAB + RPV to B/F/TAF for HIV-1 Infection.
- Conditions
- HIV-1 infectionMedDRA version: 20.1Level: LLTClassification code: 10068341Term: HIV-1 infection Class: 10021881Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- CTIS2023-506660-13-00
- Lead Sponsor
- Gilead Sciences Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 35
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 – ?????? [??????????]) ´ (????????h?? [????]) 72 ´ (?????????? ???????????????????? [????/????]) = ???????? (????/??????) b) Female: (140 – ?????? [??????????]) ´ (????????h?? [????]) 72 ´ (?????????? ???????????????????? [????/????]) × 0.85 = ???????? (????/??????), 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: 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;Secondary Objective: To assess the pharmacokinetics of bictegravir (BIC), CAB and RPV after switching to B/F/TAF from CAB+RPV, To assess the efficacy and persistence of B/F/TAF after switching from CAB+RPV, To assess the safety of B/F/TAF after switching from CAB+RPV through Week 24, To evaluate treatment satisfaction of switching to B/F/TAF from CAB+RPV;Primary end point(s): Proportion of participants experiencing treatment-emergent Grade 3 or 4 study drug-related adverse events (AEs) through Week 12, Proportion of participants experiencing treatment-emergent Grade 3 or 4 laboratory abnormalities through Week 12
- Secondary Outcome Measures
Name Time Method Secondary end point(s):Plasma concentrations of BIC, CAB and RPV at Day 1, Week 4, 12, and 24, as appropriate;Secondary end point(s):Proportion of participants with HIV-1 RNA = 50 copies/mL at Weeks 12 and 24 (missing = excluded and discontinuation = failure);Secondary end point(s):Number and proportion of participants with B/F/TAF discontinuation by Weeks 12 and 24;Secondary end point(s):Proportion of participants experiencing treatment-emergent grade 3 or 4 laboratory abnormalities through Week 24;Secondary end point(s):Change in HIV treatment satisfaction (HIVTSQc) score at Week 4