Healthy volunteers (Pre-exposure prophylaxis (PrEP) of human immunodeficiency virus 1 (HIV-1)) MedDRA version: 20.0 Level: LLT Classification code 10073527 Term: HIV pre-exposure prophylaxis System Organ Class: 100000004865
Conditions
Interventions
Product Code: F/TAF
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: EMTRICITABINE
CAS Number: 143491-57-0
Current Sponsor code: F
Concentration unit: mg milligram(s)
Concentration type: e
Sponsors
Gilead Sciences, Inc.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Subjects must be at high risk of sexual acquisition of HIV and meet all of the following inclusion criteria to be eligible for participation in this study. 1) HIV-1 negative status 2) MSM or TGW (male at birth) who have at least one of the following: a) condomless anal intercourse with at least two unique male partners in the past 12 weeks (partners must be either HIV-infected or of unknown HIV status) b) documented history of syphilis in the past 24 weeks c) documented history of rectal gonorrhea or chlamydia in the past 24 weeks 3) Age = 18 years 4) Estimated GFR = 60 mL/min according to the Cockcroft-Gault formula for creatinine clearance 5) Adequate liver and hematologic function 6) Willing and able to comply with study procedures Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 4900 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following exclusion criteria are not to be enrolled in this study. 1) Known hypersensitivity to the IMP, the metabolites, or formulation excipient 2) Have a suspected or known active, serious infection(s) 3) Acute viral hepatitis A, B or C or evidence of chronic hepatitis B infection. Subjects found to be susceptible to HBV infection should be referred for HBV vaccination. Subjects found to be positive for HCV at screening must not have active infection or must have completed treatment and achieved a sustained virologic response. 4) Need for continued use of any contraindicated concomitant medications 5) Have an implanted defibrillator or pacemaker 6) Have a history of osteoporosis or bone fragility fractures 7) Current alcohol or substance abuse judged by the Investigator to be problematic such that it potentially interferes with subject study compliance 8) Grade 3 or Grade 4 proteinuria or glycosuria that is unexplained or not clinically manageable 9) 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 dosing requirements 10) Have received investigational agents for the treatment or prevention of HIV-1 infection in the 30 days prior to screening 11) Participation in any other clinical trial (including observational trials) without prior approval from the sponsor is prohibited while participating in this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is: -To assess the rates of HIV-1 infection in men (MSM) and transgender women (TGW) who have sex with men who are administered daily F/TAF or F/TDF with a minimum follow-up of 48 weeks and at least 50% of subjects have 96 weeks of follow-up after randomization ;Secondary Objective: The secondary objectives of this study are: - To compare bone safety between the treatments as determined by dual energy x-ray absorptiometry (DXA) tests of hip and spine bone mineral density (BMD) in a subset of participants at Week 48 and Week 96 in the blinded phase - To compare renal safety between the treatments as determined by urine retinol-binding protein (RBP) to creatinine ratio, urine beta-2-microglobulin to creatinine ratio, urine protein to creatinine ratio (UPCR), and serum creatinine at Week 48 and Week 96 in the blinded phase - To assess the rates of HIV-1 infection in men (MSM) and transgender women (TGW) who have sex with men who are administered daily F/TAF or F/TDF when all subjects have 96 weeks of follow-up after randomization - To compare the general safety between the treatments Further exploratory endpoints are included as per the protocol.;Primary end point(s): The primary endpoint will be the incidence of HIV-1 infection per 100 PY when all subjects have a minimum follow-up of 48 weeks and at least 50% of the subjects have 96 weeks of follow-up after randomization. HIV-1 infection is defined by one or more of the following criteria of contributing HIV tests performed via central lab or local lab: 1) Serologic evidence of seroconversion (reactive screening HIV Antigen/Antibody or Antibody test, confirmed by reactive HIV-1/HIV-2 differentiation assay), excluding HIV vaccinated subjects, or 2) Virologic evidence of HIV-1 infection (positive qualitative HIV-1 RNA test or any detectable quantitative HIV-1 RNA test), or 3) Evidence of acute HIV-1 infection (reactive p24 Antigen or positive qualitative or quanti | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The key (a-controlled) secondary endpoints in the blinded phase are: - The percent change from baseline in hip BMD at Week 48 in a subset of subjects - The percent change from baseline in spine BMD at Week 48 in a subset of subjects - Assessment of renal biomarkers at Week 48 ? - percent change from baseline in urine beta-2-microglobulin to creatinine ratio ? - percent change from baseline in urine RBP to creatinine ratio ? - distribution of UP and UPCR categories - The change from baseline in serum creatinine at Week 48 Other secondary endpoints include: - The incidence of HIV-1 infection (as defined by Appendix 6) per 100 PY when all subjects have 96 weeks of follow-up after randomization - The percent change from baseline in hip and spine BMD at Week 96 in the blinded phase in a subset of subjects - Assessment of renal biomarkers at Week 96 in the blinded phase - percent change from baseline in urine beta-2-microglobulin to creatinine ratio - percent change from baseline in urine RBP to creatinine ratio - distribution of UP and UPCR categories - The change from baseline in serum creatinine at Week 96 in the blinded phase - The incidence of treatment-emergent adverse events and laboratory toxicities;Timepoint(s) of evaluation of this end point: Week 48, Week 96. | — |
Countries
Austria, Canada, Denmark, France, Germany, Ireland, Italy, Netherlands, Spain, United Kingdom, United States
Contacts
Public ContactClinical Trials Mailbox
Gilead Sciences International Ltd.
Outcome results
None listed