The goal of this clinical study is to learn more about the study drug, lenacapavir (LEN). The study will assess the safety, tolerability, and efficacy of long-acting LEN when combined with other medicines in adolescents and children living with HIV-1 who weigh at least 35 kg and have been treated before for HIV-1. The study will also see how easy it is for participants to take LEN as injection or an oral pill.
The primary objectives are to evaluate the pharmacokinetics and safety of LEN in combination with optimized background regimen (OBR) in TE pediatric participants with HIV-1.
Body weight at screening ≥ 35 kg.
On a stable failing antiretroviral (ARV) regimen for > 8 weeks before screening and willing to continue the regimen until Day 1.
Plasma HIV-1 RNA ≥ 400 copies/mL on at least 2 consecutive occasions spanning at least 6 months, including at screening.
Have previously changed their ARV regimen due to treatment failure.
Life expectancy ≤ 1 year.
An opportunistic illness requiring treatment within the 30 days prior to screening.
Evidence of active pulmonary or extra-pulmonary tuberculosis within 3 months prior to screening.
Hepatitis C virus (HCV) antibody positive with detectable HCV RNA at screening.
Single group
Oral Lenacapavir
DrugTablets administered without regard to food
Subcutaneous Lenacapavir
DrugAdministered via subcutaneous injections
Optimized Background Regimen (OBR)
DrugOptimized background regimen as prescribed by the Investigator
Pharmacokinetic (PK) Parameter: Ctrough, W26 of Lenacapavir (LEN)
Ctrough, W26 is defined as the plasma concentration at the end of the dosing interval at Week 26.
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) Through Week 26
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Through Week 26
PK Parameter: Cmax, D1-W26 of LEN
Cmax, D1-W26 is defined as the maximum observed concentration of drug from Day 1 to Week 26.
PK Parameter: AUC D1-W26 of LEN
AUC D1-W26 is defined as the partial area under the concentration versus time curve from Day 1 to Week 26.
Percentage of Participants Experiencing Treatment-Emergent AEs Through Week 52
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Through Week 52
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