A Phase 3, Single-Arm Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Once-Yearly Intramuscular Lenacapavir for HIV Pre-exposure Prophylaxis (PrEP) in People With an Indication for PrEP
Trial Snapshot
- Phase
- Phase 3
- Status
- Active, not recruiting
- Sponsor
- Gilead Sciences
- Enrollment
- 339
- Locations
- 55
- Primary Endpoint
- Plasma LEN Ctrough at Week 52
Study Overview
Brief Summary
The goal of this clinical study is to learn more about the study drug lenacapavir (LEN), safety, tolerability, and pharmacokinetics (how LEN is absorbed, modified, distributed, and removed from the body of the participants) of once-yearly intramuscular for HIV pre-exposure prophylaxis (PrEP) in people with an indication for PrEP.
The primary objective of this study is to evaluate the pharmacokinetics (PK) and the safety and tolerability of intramuscular (IM) every 12 months (Q12M) LEN for PrEP among people with an indication for PrEP.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 16 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •At least 16 years of age at screening.
- •Receptive anal or vaginal sex in the past 6 months and at least 1 of the following:
- •Condomless receptive sex (vaginal or anal) with 1 or more sex partners of unknown HIV status during the past 6 months
- •For a person who has engaged in anal sex in the past 6 months: diagnosis of syphilis, gonorrhea, or chlamydia in the past 6 months
- •For a person who has engaged in vaginal sex in the past 6 months: diagnosis of syphilis or gonorrhea in the past 6 months
- •Sex with partner known to be living with HIV with an unknown or detectable viral load in the past 6 months
- •Negative local rapid fourth generation HIV-1/2 antibody (Ab)/antigen (Ag) test, central fourth generation HIV-1/2 Ab/Ag, and HIV-1 RNA quantitative nucleic acid amplification testing (NAAT) at screening.
Exclusion Criteria
- •Current signs or symptoms suggesting HIV infection
- •Acute viral hepatitis A, B, or C or evidence of chronic hepatitis B or C infection
- •Severe hepatic impairment or a history of or current clinical decompensated liver cirrhosis (eg, ascites, encephalopathy, variceal bleeding)
- •Past or current participation in HIV vaccine or HIV broadly neutralizing antibody study unless participant provides documentation of receipt of placebo (ie, not active product)
- •Prior use of oral LEN in the past 90 days or subcutaneous LEN in the past 18 months
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Arms & Interventions
Lenacapavir (LEN)
Participants with an indication for pre-exposure prophylaxis will receive for approximately 52 weeks:
- LEN 3000 mg injection once on Day 1
- Oral LEN 600 mg on Day 1 and Day 2 during the Main Study Period
Participant will receive additional oral LEN if IM injection are not available.
If participants choose to not receive additional LEN injections, they will continue onto the pharmacokinetic (PK) Tail Phase for up to 52 weeks.
Intervention: Lenacapavir Tablet (Drug)
LEN Extension Phase
Participants with an indication for pre-exposure prophylaxis will receive LEN 3000 mg injection once on Day 1 (approximately one year after their initial dose) during the Extension Phase.
Participants will receive oral LEN if IM injections are not available.
If participants choose to not receive additional LEN injections, they will continue onto the PK Tail Phase for up to 52 weeks.
Intervention: Lenacapavir Tablet (Drug)
Lenacapavir (LEN)
Participants with an indication for pre-exposure prophylaxis will receive for approximately 52 weeks:
- LEN 3000 mg injection once on Day 1
- Oral LEN 600 mg on Day 1 and Day 2 during the Main Study Period
Participant will receive additional oral LEN if IM injection are not available.
If participants choose to not receive additional LEN injections, they will continue onto the pharmacokinetic (PK) Tail Phase for up to 52 weeks.
Intervention: Lenacapavir Injection (Drug)
LEN Extension Phase
Participants with an indication for pre-exposure prophylaxis will receive LEN 3000 mg injection once on Day 1 (approximately one year after their initial dose) during the Extension Phase.
Participants will receive oral LEN if IM injections are not available.
If participants choose to not receive additional LEN injections, they will continue onto the PK Tail Phase for up to 52 weeks.
Intervention: Lenacapavir Injection (Drug)
Outcomes
Primary Outcomes
Plasma LEN Ctrough at Week 52
Time Frame: Week 52
Ctrough is defined as the concentration at the end of the dosing interval.
Percentage of Participants Experiencing Treatment-emergent Clinical Laboratory Abnormalities
Time Frame: First dose up to 30 days post last dose (up approximately 3 years)
Percentage of Participants Experiencing Treatment-emergent Adverse Event (TEAEs)
Time Frame: First dose up to 30 days post last dose (approximately 3 years)
Percentage of Participants With Discontinuation due to Adverse Event
Time Frame: First dose up to 30 days post last dose (approximately 3 years)
Secondary Outcomes
No secondary outcomes reported