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Study of Lenacapavir Taken Twice a Year for HIV Pre-Exposure Prophylaxis (PrEP)
EU CTIS ID: 2023-507891-31-00
What this study is testing
Compare LEN and F/TDF persistence among people who would benefit from PrEP
- Phase II and Phase III (Integrated)
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
- Able to comprehend and provide a signed written informed consent, which must be obtained prior to initiation of study procedures.
- Cisgender men who have sex with men, transgender women, transgender men, cisgender women, and nonbinary people
- At least 18 years of age at screening
- Increased likelihood of HIV acquisition as indicated by at least one of the following: a) Condomless sex with ≥ 2 partners in the past 6 months b) Diagnosis of a bacterial sexually transmitted infection (STI) in the past 12 months c) Engagement in sex work or transactional sex in the past 12 months d) Use of ≥ 2 courses of nonoccupational HIV postexposure prophylaxis (nPEP) in the past 12 months e) Condomless sex with a partner living with HIV who has unknown or unsuppressed viral load (≥ 200 copies/mL) in the past 12 months
- Negative local rapid HIV-1/2 antibody (Ab)/antigen (Ag) test, central HIV-1/2 Ab/Ag, and HIV-1 RNA quantitative nucleic acid amplification testing (NAAT) at screening
- Estimated glomerular filtration rate (eGFR) at least 60 mL/min at screening according to the Cockcroft-Gault formula for creatinine clearance (CLcr): (140 - age in years) × (weight in kg) x [0.85 if female] = CLcr (mL/min) 72 × (serum creatinine in mg/dL)
You likely can't join if
- Coenrollment in any other clinical study (including observational) without prior approval from the sponsor is prohibited while participating in this study.
- 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 adherence.
- Grade 3 or Grade 4 proteinuria or glycosuria at screening that is unexplained or not clinically manageable.Grade 3 or Grade 4 proteinuria or glycosuria at screening that is unexplained or not clinically manageable.
- Participants of childbearing potential who are pregnant or lactating at screening or on Day 1. Participants of childbearing potential must have a negative pregnancy test at screening and on Day 1 (see “Definition of Childbearing Potential” in Appendix 11.4 of the Protocol).
- Any other clinical condition, laboratory abnormalities, or psychosocial 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.
See the full eligibility criteria
Who can join
- Able to comprehend and provide a signed written informed consent, which must be obtained prior to initiation of study procedures.
- Cisgender men who have sex with men, transgender women, transgender men, cisgender women, and nonbinary people
- At least 18 years of age at screening
- Increased likelihood of HIV acquisition as indicated by at least one of the following: a) Condomless sex with ≥ 2 partners in the past 6 months b) Diagnosis of a bacterial sexually transmitted infection (STI) in the past 12 months c) Engagement in sex work or transactional sex in the past 12 months d) Use of ≥ 2 courses of nonoccupational HIV postexposure prophylaxis (nPEP) in the past 12 months e) Condomless sex with a partner living with HIV who has unknown or unsuppressed viral load (≥ 200 copies/mL) in the past 12 months
- Negative local rapid HIV-1/2 antibody (Ab)/antigen (Ag) test, central HIV-1/2 Ab/Ag, and HIV-1 RNA quantitative nucleic acid amplification testing (NAAT) at screening
- Estimated glomerular filtration rate (eGFR) at least 60 mL/min at screening according to the Cockcroft-Gault formula for creatinine clearance (CLcr): (140 - age in years) × (weight in kg) x [0.85 if female] = CLcr (mL/min) 72 × (serum creatinine in mg/dL)
- Body weight at least 35 kg
- Willing and able to follow study procedures
- Participants of childbearing potential who are receiving teratogenic medications, including testosterone, who engage in frontal (vaginal) intercourse must not intend to become pregnant during the study and must agree to utilize protocol-specified method(s) of contraception as described in Appendix 11.4. of the Protocol.
What rules you out
- Coenrollment in any other clinical study (including observational) without prior approval from the sponsor is prohibited while participating in this study.
- 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 adherence.
- Grade 3 or Grade 4 proteinuria or glycosuria at screening that is unexplained or not clinically manageable.Grade 3 or Grade 4 proteinuria or glycosuria at screening that is unexplained or not clinically manageable.
- Participants of childbearing potential who are pregnant or lactating at screening or on Day 1. Participants of childbearing potential must have a negative pregnancy test at screening and on Day 1 (see “Definition of Childbearing Potential” in Appendix 11.4 of the Protocol).
- Any other clinical condition, laboratory abnormalities, or psychosocial 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.
- Known hypersensitivity to the study drug, the metabolites, or formulation excipient.
- Current use of PrEP, defined as self-report of the use of PrEP in the preceding 4 weeks. PrEP should not be discontinued to facilitate study participation.
- Current use of nPEP, unless the prescribed course will be completed prior to randomization.
- Past or current participation in HIV vaccine or HIV broadly neutralizing Ab study unless participant provides documentation of receipt of placebo (ie, not active product).
- Acute viral hepatitis A, B, or C or evidence of chronic hepatitis B or C infection a) If a participant has a negative hepatitis B surface antigen (HBsAg), negative hepatitis B surface antibody (HBsAb), and positive hepatitis B core antibody (HBcAb), hepatitis B virus (HBV) DNA testing will be completed. If the HBV DNA result is positive, the participant is a screen failure. Participants found to be susceptible to HBV infection will be offered HBV vaccination. b) If the hepatitis C virus (HCV) Ab result is positive, then HCV RNA will be evaluated. Participants found to be positive for HCV at screening must not have active infection or must have completed treatment and achieved a sustained virologic response.
- Severe hepatic impairment or a history of or current clinical decompensated liver cirrhosis (eg, ascites, encephalopathy, variceal bleeding).
- Have a suspected or known active, serious infection(s) (eg, active tuberculosis, etc).
- Need for continued use of any contraindicated concomitant medications.
The study team makes the final eligibility decision.
Where it's taking place
- 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 all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include 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.