CTIS2023-506660-13-00
Recruiting
Phase 1
A Phase 4 Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Oral B/F/TAF after Discontinuing Injectable CAB + RPV - GS-US-380-6738
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- HIV-1 infection
- Sponsor
- Gilead Sciences Inc.
- Enrollment
- 35
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion 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 – ?????? \[??????????]) ´ (????????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)
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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