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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 Infection
EU CTIS ID: 2022-501763-40-00
What this study is testing
To assess the rates of HIV-1 infection in men who have sex with 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 participants have 96 weeks of follow up after randomization
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- HIV-1–negative status
- MSM or TGW (male at birth) who have at least one of the following: a) condomless anal intercourse with at least 2 unique male partners in the past 12 weeks (partners must be either PWH 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
- Age ≥ 18 years
- Estimated glomerular filtration rate (eGFR) ≥ 60 mL/min according to the Cockcroft-Gault formula for creatinine clearance {Cockcroft 1976}: (140 ― age in years) × (wt in kg) / 72 × (serum creatinine in mg/dL) = CLcr(mL/min)
- Adequate liver and hematologic function: • AST and alanine aminotransferase (ALT) ≤ 2.5 × upper limit of normal (ULN); and total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin • Absolute neutrophil count ≥ 1000/mm3, platelets ≥ 75,000/mm3, and hemoglobin ≥ 10 g/dL
- Willing and able to comply with study procedures
You likely can't join if
- Known hypersensitivity to the study drug, the metabolites, or formulation excipient.
- Have received investigational agents for the treatment or prevention of HIV-1 infection in the 30 days prior to screening
- Participation in any other clinical study (including observational studies) without prior approval from the sponsor is prohibited while participating in this study
- Have a suspected or known active, serious infection(s)
- Acute viral hepatitis A, B, or C or evidence of chronic hepatitis B infection. Participants found to be susceptible to hepatitis B virus (HBV) infection should be referred for HBV vaccination. Participants found to be positive for hepatitis C virus (HCV) at screening must not have active infection or must have completed treatment and achieved a sustained virologic response.
- Need for continued use of any contraindicated concomitant medications
See the full eligibility criteria
- HIV-1–negative status
- MSM or TGW (male at birth) who have at least one of the following: a) condomless anal intercourse with at least 2 unique male partners in the past 12 weeks (partners must be either PWH 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
- Age ≥ 18 years
- Estimated glomerular filtration rate (eGFR) ≥ 60 mL/min according to the Cockcroft-Gault formula for creatinine clearance {Cockcroft 1976}: (140 ― age in years) × (wt in kg) / 72 × (serum creatinine in mg/dL) = CLcr(mL/min)
- Adequate liver and hematologic function: • AST and alanine aminotransferase (ALT) ≤ 2.5 × upper limit of normal (ULN); and total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin • Absolute neutrophil count ≥ 1000/mm3, platelets ≥ 75,000/mm3, and hemoglobin ≥ 10 g/dL
- Willing and able to comply with study procedures
- Known hypersensitivity to the study drug, the metabolites, or formulation excipient.
- Have received investigational agents for the treatment or prevention of HIV-1 infection in the 30 days prior to screening
- Participation in any other clinical study (including observational studies) without prior approval from the sponsor is prohibited while participating in this study
- Have a suspected or known active, serious infection(s)
- Acute viral hepatitis A, B, or C or evidence of chronic hepatitis B infection. Participants found to be susceptible to hepatitis B virus (HBV) infection should be referred for HBV vaccination. Participants found to be positive for hepatitis C virus (HCV) at screening must not have active infection or must have completed treatment and achieved a sustained virologic response.
- Need for continued use of any contraindicated concomitant medications
- Have an implanted defibrillator or pacemaker
- Have a history of osteoporosis or bone fragility fractures
- Current alcohol or substance abuse judged by the investigator to be problematic such that it potentially interferes with participant study compliance
- Grade 3 or Grade 4 proteinuria or glycosuria that is unexplained or not clinically manageable.
- Any other clinical condition or prior therapy that, in the opinion of the investigator, would make the participant unsuitable for the study or unable to comply with dosing requirements
The study team makes the final eligibility decision.
Where it's taking place
- Canada
- United States
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canada; United States; United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.