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

Phase 1

• Conditions: Healthy volunteers (Pre-exposure prophylaxis (PrEP) of human immunodeficiency virus 1 (HIV-1)); MedDRA version: 20.0Level: LLTClassification code 10073527Term: HIV pre-exposure prophylaxisSystem Organ Class: 100000004865; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2016-001399-31-DE
• Lead Sponsor: Gilead Sciences, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-08-31
• Last Update Posted: 6 December 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: 5000

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) Sign a written informed consent form, which must be obtained prior
to initiation of study procedures after being duly informed
2) HIV-1 negative status
3) 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
4) Age = 18 years
5) Estimated GFR = 60 mL/min according to the Cockcroft-Gault formula for creatinine clearance
6) Adequate liver and hematologic function
7) 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

Subjects who meet any of the following exclusion criteria are not to be enrolled in this study.
1) Have been committed to an institution by virtue of an order issued
either by the judicial or the administrative authorities
2) Are dependent on GSI, investigator or study site and generally
subjects whose willingness to participate in this study may be unduly
influenced by the expectation, whether justified or not, of benefits
associated with participation, or of a retaliatory response from senior
members of a hierarchical structure
3) Known hypersensitivity to the IMP, the metabolites, or formulation excipient
4) Have a suspected or known active, serious infection(s)
5) 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.
6) Need for continued use of any contraindicated concomitant medications
7) Have an implanted defibrillator or pacemaker
8) Have a history of osteoporosis or bone fragility fractures
9) Current alcohol or substance abuse judged by the Investigator to be problematic such that it potentially interferes with subject study compliance
10) Grade 3 or Grade 4 proteinuria or glycosuria that is unexplained or not clinically manageable
11) 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
12)Have received investigational agents for the treatment or prevention of HIV-1 infection in the 30 days prior to screening
13) 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