HIV Pre-exposure Prophylaxis
Conditions
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.
Interventions
Administered intramuscularly
Administered orally
Sponsors
Gilead Sciences
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
It is a single arm study that means all participants will receive LEN. However, the study provides LEN in 2 phases, therefore, the two phases are reported as 2 separate arms.
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Key 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: 1. Condomless receptive sex (vaginal or anal) with 1 or more sex partners of unknown HIV status during the past 6 months 2. 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 3. For a person who has engaged in vaginal sex in the past 6 months: diagnosis of syphilis or gonorrhea in the past 6 months 4. 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. Key
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma LEN Ctrough at Week 52 | Week 52 | Ctrough is defined as the concentration at the end of the dosing interval. |
| Percentage of Participants Experiencing Treatment-emergent Adverse Event (TEAEs) | First dose up to 30 days post last dose (approximately 3 years) | — |
| Percentage of Participants Experiencing Treatment-emergent Clinical Laboratory Abnormalities | First dose up to 30 days post last dose (up approximately 3 years) | — |
| Percentage of Participants With Discontinuation due to Adverse Event | First dose up to 30 days post last dose (approximately 3 years) | — |
Countries
United States
Contacts
CONTACTGilead Clinical Study Information Center
STUDY_DIRECTORGilead Study Director
Gilead Sciences
Outcome results
None listed