A Phase 2 interventional study of Oral Lenacapavir and Subcutaneous Lenacapavir in HIV-1-infection, sponsored by Gilead Sciences. Recruiting at 9 sites in 2 countries. Open to participants aged Up to 17 Years. Per ClinicalTrials.gov, last updated 2026-04-24.
Sponsored by Gilead Sciences · Phase 2, Interventional, and Treatment
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.
Gilead Sciences is the lead sponsor of 680 studies on the registry; 24 are open to participants now.
Of its 259 completed or terminated interventional studies of FDA-regulated products, 249 (96%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
The following laboratory parameters at screening:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Participants will receive oral LEN 600 mg on Days 1 and 2. Participants will also receive 2 doses of LEN 927 mg as subcutaneous (SC) injection on Day 1 and Week 26 along with their OBR per clinical practice. At the Week 52, participants will be given the option to receive SC LEN every 6 months while continuing their OBR for at least another 2 SC LEN doses in the extension phase.
Drug: Oral Lenacapavir · Drug: Subcutaneous Lenacapavir · Drug: Optimized Background Regimen (OBR)
Tablets administered without regard to food
Also known as: GS-6207, Sunlenca®
Administered via subcutaneous injections
Also known as: GS-6207, Sunlenca®
Optimized 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.
Time frame: Week 26
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) Through Week 26
Time frame: First dose date up to Week 26
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Through Week 26
Time frame: First dose date up to 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.
Time frame: Day 1 up 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.
Time frame: Day 1 up to Week 26
Percentage of Participants Experiencing Treatment-Emergent AEs Through Week 52
Time frame: First dose date up to Week 52
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Through Week 52
Time frame: First dose date up to Week 52
Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL at Week 26 Based on the US Food and Drug Administration (FDA)-Defined Snapshot Algorithm
Time frame: Week 26
Percentage of Participants with Plasma HIV-1 RNA < 50 Copies/mL at Week 52 Based on the US FDA-Defined Snapshot Algorithm
Time frame: Week 52
Change From Baseline in Clusters of Differentiation (CD4)+ Cell Counts at Week 26
Time frame: Baseline, Week 26
Change From Baseline in CD4+ Cell Counts at Week 52
Time frame: Baseline, Week 52
Percent Change From Baseline in CD4+ at Week 26
Time frame: Baseline, Week 26
Percent Change From Baseline in CD4+ at Week 52
Time frame: Baseline, Week 52
General Acceptability of Oral LEN as Assessed by Percentage of Participants With Acceptability Questionnaire Responses on Day 1
To assess the acceptability of the study drug, the participants will complete questionnaire including a question on general acceptability of the assigned study drug on an ordinal 5-category scale.
Time frame: Day 1
General Acceptability of Oral LEN as Assessed by Percentage of Participants With Acceptability Questionnaire Responses on Day 2
To assess the acceptability of the study drug, the participants will complete questionnaire including a question on general acceptability of the assigned study drug on an ordinal 5-category scale.
Time frame: Day 2
General Palatability of Oral LEN as Assessed by Percentage of Participants With Palatability Questionnaire Responses on Day 1
To assess the palatability of the study drug, the participants will complete questionnaire including a question on general palatability of the assigned study drug on an ordinal 5-category scale.
Time frame: Day 1
General Palatability of Oral LEN as Assessed by Percentage of Participants With Palatability Questionnaire Responses on Day 2
To assess the palatability of the study drug, the participants will complete questionnaire including a question on general palatability of the assigned study drug on an ordinal 5-category scale.
Time frame: Day 2
Plan to share: No
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