Human Immunodeficiency Virus (HIV-1) Infection MedDRA version: 20.1 Level: LLT Classification code 10068341 Term: HIV-1 infection System Organ Class: 100000004862
Conditions
Sponsors
Gilead Sciences, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following inclusion criteria to be eligible for participation in this study. 1) The ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures 2) Age = 65 years 3) Currently receiving an ARV regimen of E/C/F/TAF FDC (or FTC/TDF + 3rd agent if currently or previously participated in GS-US-292-1826) for = 3 months 4) Documented plasma HIV-1 RNA 1 year 12) Hepatic transaminases (AST and ALT) = 5 upper limit of normal (ULN) 13) Total bilirubin = 1.5X ULN or normal direct bilirubin 14) Adequate hematologic function (absolute neutrophil count = 750/mm3 (= 0.75 GI/L); platelets = 50,000/mm3 (= 50 GI/L); hemoglobin = 8.5 g/dL (= 85 g/L)) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 80
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following exclusion criteria are not to be enrolled in this study. 1) An opportunistic illness indicative of stage 3 HIV diagnosed within the 30 days prior to screening 2) Subjects experiencing decompensated cirrhosis (eg, ascites, encephalopathy, or variceal bleeding) 3) Have been treated with immunosuppressant therapies or chemotherapeutic agents within 3 months of study screening, or expected to receive these agents or systemic steroids (e.g. prednisone doses > 10 mg daily or equivalent) during the study (eg, corticosteroids, immunoglobulins, and other immune- or cytokine-based therapies) 4) Current alcohol or substance use judged by the Investigator to potentially interfere with subject study compliance 5) Malignancy within 5 years of screening other than cutaneous Kaposi’s sarcoma, completely resected non-melanoma skin cancer (basal cell carcinoma or non-invasive cutaneous squamous carcinoma), or completely resected carcinoma in-situ of the cervix (CIN 3) or anus (AIN 3). A prior malignancy treated with curative therapy and for which there has been no evidence of disease for at least five years prior to screening is allowed. 6) Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to Day 1 7) Participation in any other clinical trial, including observational studies, without prior approval from the Medical Monitor 8) Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable to comply with the dosing requirements 9) Known hypersensitivity to B/F/TAF FDC tablets, their metabolites, or formulation excipient 10) Subjects receiving ongoing therapy with any of the medications listed in the protocol, including drugs not to be used with BIC, FTC, and TAF 11) Acute hepatitis in the 30 days prior to study entry 12) Active tuberculosis infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): HIV-1 RNA <50 copies/mL at Week 24 - defined by the Food and Drug Administration (FDA) snapshot algorithm;Timepoint(s) of evaluation of this end point: Week 24;Main Objective: To characterize the virologic efficacy of switching virologically suppressed subjects on an E/C/F/TAF FDC or TDF-containing regimen to B/F/TAF FDC defined by HIV-1 RNA <50 copies/mL at Week 24;Secondary Objective: - To characterize the safety and tolerability of switching to B/F/TAF FDC from an E/C/F/TAF FDC or TDF-containing regimen through Week 96. - To characterize the virologic efficacy of switching to B/F/TAF FDC defined by HIV-1 RNA <50 copies/mL at Week 48, Week 72 and Week 96. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Adverse events through Week 24 - Adverse events through Week 48 - Adverse events through Week 72 - Adverse events through Week 96 - HIV-1 RNA <50 copies/mL at Week 48 - defined by the Food and Drug Administration (FDA) snapshot algorithm - HIV-1 RNA <50 copies/mL at Week 72 - defined by the Food and Drug Administration (FDA) snapshot algorithm - HIV-1 RNA <50 copies/mL at Week 96 - defined by the Food and Drug Administration (FDA) snapshot algorithm;Timepoint(s) of evaluation of this end point: Week 24, Week 48, Week 72 and Week 96. | — |
Countries
Belgium, France, Italy, Spain, United Kingdom
Contacts
Public ContactClinical Trials Mailbox
Gilead Sciences International Ltd.
Outcome results
None listed