A Phase 3, Randomized, Double-blind Study to Evaluate the Safety and Efficacy of Emtricitabine and Tenofovir Alafenamide (F/TAF) Fixed-Dose Combination Once Daily for Pre-Exposure Prophylaxis in Men and Transgender Women Who Have Sex with Men and Are At Risk of HIV-1 Infectio

Phase 3

Recruiting

• Conditions: HIV preventie; HIV

• Registration Number: NL-OMON55726
• Lead Sponsor: Gilead Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 80

Inclusion Criteria

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

Exclusion Criteria

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 trail (including observational trails)
without prior approval from the sponsor is prohibited while participating in
this trial.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified