A study to compare the safety and effectiveness of F/TAF vs F/TDF (Truvada) once daily for the prevention of HIV, in men and transgender women who have sex with men and are at risk of HIV infectio
- Conditions
- Therapeutic area: Diseases [C] - Virus Diseases [C02]Healthy volunteers (Pre-exposure prophylaxis (PrEP) of human immunodeficiency virus 1 (HIV-1))MedDRA version: 19.0Level: LLTClassification code 10073527Term: HIV pre-exposure prophylaxisSystem Organ Class: 100000004865
- Registration Number
- EUCTR2016-001399-31-ES
- Lead Sponsor
- Gilead Sciences, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Male
- Target Recruitment
- 5000
Subjects must 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
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 or evidence of chronic hepatitis B infection. Subjects found to be susceptible to HBV infection should be referred for HBV vaccination
4) Evidence or known history of hepatitis C infection
5) Need for continued use of any contraindicated concomitant medications
6) Have an implanted defibrillator or pacemaker
7) Have a history of osteoporosis or bone fragility fractures
8) Current alcohol or substance abuse judged by the Investigator to be problematic such that it potentially interferes with subject study compliance
9) Grade 3 or Grade 4 proteinuria or glycosuria that is unexplained or not clinically manageable
10) 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
11) In the 30 days prior to screening have received F/TDF or any other approved or investigational agent for the prevention of HIV-1 infection or during the trial would be receiving any other approved or investigational agents for the treatment/prevention of HIV-1 infection
12) Participation in any other clinical trial (including observational trials) without prior approval from the sponsor is prohibited while participating in this trial
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method