Human Immunodeficiency Virus (HIV-1) Infection MedDRA version: 20.1 Level: LLT Classification code 10068341 Term: HIV-1 infection System Organ Class: 100000004862
Conditions
Interventions
Trade Name: Biktarvy
Product Code: GS-9883/F/TAF
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: BICTEGRAVIR
CAS Number: 1807988-02-8
Current Sponsor code: GS-9883
Other descriptive name:
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) Age = 1 month to 500 cells/mm3 (> 0.50 GI/L), b) Hemoglobin > 8.5 g/dL (= 85 g/L), c) Platelets = 50,000/mm3 (= 50 GI/L) 8) Hepatic transaminases (AST and ALT) = 5 × upper limit of normal (ULN) 9) Total bilirubin = 1.5 mg/dL (= 26 µmol/L), or normal direct bilirubin 10) Documented plasma HIV-1 RNA 50 copies/mL should
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following exclusion criteria are not to be enrolled in this study. 1) Cohorts 1, 2, 3 and Cohort 4 Group 1: CD4+ cell count < 200 cells/ mm3. Cohort 4 Groups 2, 3 and 4: CD4+ cell count < 750 cells/mm3 for =1 to <12 months of age and < 500 cells/mm3 for =12 to <24 months of age. 2) An opportunistic illness indicative of stage 3 HIV diagnosed within the 30 days prior to screening 3) An ongoing serious infection requiring systemic antibiotic therapy at the time of screening 4) Evidence of active pulmonary or extra-pulmonary tuberculosis within 3 months 5) Acute hepatitis in the 30 days prior to study entry 6) Hepatitis B virus (HBV) surface antigen (HBsAg) positive 7) Hepatitis C virus (HCV) antibody positive with detectable HCV RNA. Children < 18 months of age born to an HCV positive mother and/or HCV antibody positive will need to have 2 negative HCV RNA tests 6 months apart with the first test occurring no earlier than 2 months of age. In this situation, the earliest such a patient can be screened for study eligibility is at 8 months of age. 8) Have any serious or active medical or psychiatric illness which, in the opinion of the Investigator, would interfere with subject treatment, assessment, or compliance with the protocol. This would include uncontrolled renal, cardiac, hematological, hepatic, pulmonary (including chronic asthma), endocrine (e.g., diabetes), central nervous, gastrointestinal (including an ulcer), vascular, metabolic (thyroid disorders, adrenal disease), immunodeficiency disorders, active infection, or malignancy that are clinically significant or requiring treatment within 30 days prior to Day 1. 9) Subjects experiencing decompensated cirrhosis (eg, ascites, encephalopathy) 10) A history of or ongoing malignancy other than cutaneous Kaposi’s sarcoma (KS), basal cell carcinoma, or resected, non-invasive cutaneous squamous carcinoma. Subjects with biopsy-confirmed cutaneous KS are eligible, but must not have received any systemic therapy for KS within 30 days of Day 1 and are not anticipated to require systemic therapy during the study 11) Females who are pregnant (as confirmed by positive serum pregnancy test) 12) Females who are breastfeeding 13) = 2 months of age and gestational age (GA) = 37 weeks (Cohort 4 Groups 2, 3 and 4) 14) Current alcohol or substance abuse judged by the Investigator to potentially interfere with subject compliance 15) Have history of significant drug sensitivity or drug allergy 16) Known hypersensitivity to the investigational medicinal product (IMP), the metabolites, or formulation excipients 17) Participation in any other clinical trial, including observational studies without prior approval from sponsor is prohibited while participating in this trial 18) Cohort 4 Groups 2, 3, and 4: Last dose of nevirapine (NVP) or efavirenz (EFV), if applicable, = 14 days prior to enrolment 19) Subjects receiving ongoing therapy with any medication that is not to be taken with the study drug. Administration of any of the following medications must be discontinued at least 30 days prior to the Day 1 visit and for the duration of the study, with the exception of the subject’s prior ARV treatment regimen, which must be continued until their scheduled Day 1 visit. - Antiarrhythmic agent: dofetilide - Anticonvulsants: phenobarbital, phenytoin, carbamazepine, oxcarbazepine - Antimycobacterials: rifampin, rifapentine, rifabutin - Antiretrovirals: any antiretroviral drug that is
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Cohorts 1, 2 & 3: Part A: To evaluate the steady state PK of BIC and confirm dose of the B/F/TAF 50/200/25 mg FDC and dose of B/F/TAF 30/120/15 mg FDC Parts A & B: To evaluate safety and tolerability of adult strength and low dose B/F/TAF FDC through Week 24 Cohort 4: Group 1: To evaluate the safety and tolerability of B/F/TAF 30/120/15 mg FDC TOS through Week 24 Group 2: To evaluate the steady state PK of BIC and TAF and confirm the dose of B/F/TAF 15/60/7.5 mg FDC TOS To evaluate the safety and tolerability of the B/F/TAF 15/60/7.5 mg FDC TOS through Week 24 Group 3: To evaluate the steady state PK of BIC and TAF and confirm the dose of B/F/TAF 7.5/30/3.75 mg FDC TOS To evaluate the safety and tolerability of B/F/TAF 7.5/30/3.75 mg FDC TOS through Week 24 Group 4: To evaluate the steady state PK of BIC and TAF and confirm the dose of B/F/TAF 3.75/15/1.88 mg FDC TOS To evaluate the safety and tolerability of the B/F/TAF 3.75/15/1.88 mg FDC TOS through Week 24 ;Secondary Objective: Cohorts 1, 2 & 3: To evaluate safety and tolerability of adult strength and low dose B/F/TAF FDC through Week 48 To evaluate antiviral activity of adult strength and the low dose B/F/TAF FDC through Weeks 24 and 48 Cohort 4: Group 1: To evaluate safety and tolerability of B/F/TAF 30/120/15 mg FDC TOS through Week 48 To evaluate antiviral activity of B/F/TAF 30/120/15 mg FDC TOS through Weeks 24 and 48 Group 2: To evaluate safety and tolerability of the B/F/TAF 15/60/7.5 mg FDC TOS through Week 48 To evaluate antiviral activity of the B/F/TAF 15/60/7.5 mg FDC TOS through Weeks 24 and 48 Group 3: To evaluate safety and tolerability of B/F/TAF 7.5/30/3.75 mg FDC TOS through Week 48 To evaluate antiviral activity of B/F/TAF 7.5/30/3.75 mg FDC TOS through Weeks 24 and 48 Group 4: To evaluate safety and tolerability of the B/F/TAF 3.75/15/1.88 mg FDC TOS through Week 48 To evaluate antiviral activity of the low dose B/F/TAF 3.75/15/1.88 mg FDC TOS through Weeks 24 and 48 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary endpoints of this study are: - The proportion of subjects with plasma HIV-1 RNA < 50 copies/mL at Weeks 24 and 48 as defined by the US FDA-defined snapshot algorithm - Change from baseline in CD4 cell counts and percentages at Weeks 24 and 48 - PK parameters of AUClast, Cmax, Tmax, T1/2, apparent CL and apparent Vz for BIC, as applicable; AUCtau, AUClast, Cmax, Ctau, Tmax, T1/2, apparent CL and apparent Vz for TAF and FTC, as applicable - Incidence of treatment-emergent AEs, and treatment-emergent laboratory abnormalities through week 48 - Acceptability and palatability of adult B/F/TAF formulation;Timepoint(s) of evaluation of this end point: Weeks 24 and 48 respectively, as defined above | — |
Countries
South Africa, Thailand, Uganda, United States
Contacts
Public ContactClinical Trials Mailbox
Gilead Sciences International Ltd.
Outcome results
None listed