Healthy volunteers (Pre-exposure prophylaxis (PrEP) of human immunodeficiency virus 1 (HIV-1)) MedDRA version: 20.1 Level: LLT Classification code 10068341 Term: HIV-1 infection System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: Sunlenca
Product Code: GS-6207
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Lenacapavir
Current Sponsor code: GS-6207
Concentration unit: mg/ml milligram(s)/millilitre
Sponsors
Gilead Sciences, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria for the Incidence Phase: 1) The ability to comprehend and provide a signed written informed consent, which must be obtained prior to initiation of study procedures 2) Cisgender AGYW 3) Age = 16 to = 25 years at screening. 4) HIV-1 status unknown at initial screening and no prior HIV-1 testing within the last 3 months 5) Sexually active (has had = 2 vaginal intercourse encounters within the last 3 months) with CGM 6) Willing and able to comply with study procedures Inclusion Criteria for the Randomized Blinded Phase: 1) Negative local rapid fourth generation HIV-1/2 Ab/Ag test, central fourth generation HIV-1/2 Ab/Ag, and HIV-1 RNA quantitative nucleic acid amplification testing (NAAT) 2) Estimated GFR = 60 mL/min at screening according to the Cockcroft-Gault formula for CLcr 3) Body weight = 35 kg Are the trial subjects under 18? yes Number of subjects for this age range: 80 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 5289 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion Criteria for the Incidence Phase: 1) Participants who previously received an HIV vaccine or HIV broadly neutralizing antibody (bNAb) are not eligible. 2) Prior use of oral PrEP (including F/TDF) in the past 12 weeks or any prior use of long-acting systemic PrEP (including cabotegravir or islatravir) Exclusion Criteria for the Randomized Blinded Phase: 1) Participation in any other clinical trial (including observational and COVID-19 vaccine trials) without prior approval from the sponsor is prohibited while participating in this trial 2) Known hypersensitivity to the study drug, the metabolites, or formulation excipient 3) Acute viral hepatitis A, B, or C or evidence of chronic hepatitis B or C infection 4) Severe hepatic impairment or a history of or current clinical decompensated liver cirrhosis (eg, ascites, encephalopathy, variceal bleeding) 5) Have a suspected or known active, serious infection(s) (eg, active tuberculosis, etc) 6) Need for continued use of any contraindicated concomitant medications 7) Have a history of osteoporosis or bone fragility fractures 8) Current alcohol or substance abuse judged by the investigator to be problematic such that it potentially interferes with participant study adherence 9) Grade 3 or Grade 4 proteinuria or glycosuria at screening that is unexplained or not clinically manageable 10) Women who are pregnant or lactating prior to administration of the first study drug dose 11) 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate the efficacy of LEN and F/TAF in preventing the risk of HIV-1 infection relative to the background HIV-1 incidence rate. The primary objective for the Incidence Phase is: - To estimate the HIV-1 background incidence rate. The primary objectives for the Randomized Blinded Phase of this study are: - To evaluate the efficacy of LEN for HIV-1 pre-exposure prophylaxis (PrEP) in Adolescent Girls and Young Women (AGYW) at risk of HIV-1 infection - To evaluate the efficacy of F/TAF for HIV-1 PrEP in AGYW at risk of HIV-1 infection;Secondary Objective: The secondary objectives for the Randomized Blinded Phase of this study are: - To compare the efficacy of LEN with emtricitabine/tenofovir disoproxil fumarate (F/TDF) for HIV-1 PrEP in AGYW at risk of HIV-1 infection - To evaluate the efficacy of LEN for HIV-1 PrEP in AGYW at risk of HIV-1 infection in participants adherent to LEN - To evaluate the efficacy of F/TAF for HIV-1 PrEP in AGYW at risk of HIV-1 infection in participants adherent to F/TAF - To compare the efficacy of F/TAF with F/TDF for HIV-1 PrEP in AGYW at risk of HIV-1 infection - To evaluate the safety and tolerability of LEN, F/TAF, and F/TDF for HIV-1 PrEP in AGYW at risk of HIV-1 infection - To evaluate the safety and tolerability of LEN and F/TAF for HIV-1 PrEP in AGYW = 16 to < 18 years of age who have sex with male partners and are at risk for HIV-1 infection;Primary end point(s): Incidence Phase Primary Endpoint: The primary endpoint for the Incidence Phase of this study is the diagnosis of recent HIV-1 infection. The background HIV-1 incidence per 100 PY will be computed based on the recent infection testing algorithm using an HIV-1 recency assay. Randomized Blinded Phase Primary Endpoint: • Diagnosis of HIV-1 infection.;Timepoint(s) of evaluation of this end point: Week 52 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary endpoints for the Randomized Blinded Phase of this study are as follows: • Diagnosis of HIV-1 among participants while adherent to study drug (as defined by medium and high TFV-DP concentration in DBS at the time of HIV-1 diagnosis for the F/TAF and F/TDF study drug groups, and by LEN on-time administration in the past 26 weeks for the LEN study drug group). • Occurrence of treatment-emergent AEs (TEAEs) and treatment-emergent clinical laboratory abnormalities to evaluate safety and tolerability of LEN, F/TAF, and F/TDF for HIV-1 PrEP.;Timepoint(s) of evaluation of this end point: Week 52 | — |
Countries
South Africa, Uganda
Contacts
Public ContactClinical Trials Mailbox
Gilead Sciences International Ltd.
Outcome results
None listed