HIV-1-infection
Conditions
Brief summary
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.
Interventions
DRUGOral Lenacapavir
Tablets administered without regard to food
Administered via subcutaneous injections
Optimized background regimen as prescribed by the Investigator
Sponsors
Gilead Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 17 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * 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. * ARV treatment options limited due to resistance, tolerability, contraindications, safety, drug access. * Able and willing to commit to taking LEN in combination with their OBR. * The following laboratory parameters at screening: 1. Estimated glomerular filtration rate (eGFR) ≥ 60 mL/min/1.73 m\^2 using Bedside Schwartz Formula. 2. Absolute neutrophil count \> 0.50 GI/L (\> 500 cells/mm\^3). 3. Hemoglobin ≥ 85 g/L (\> 8.5 g/dL). 4. Platelets ≥ 50 GI/L (≥ 50,000/mm\^3). 5. Hepatic transaminases (aspartate aminotransferase and alanine aminotransferase) ≤ 5 × upper limit of normal. 6. Total bilirubin ≤ 23 μmol/L (≤ 1.5 mg/dL) and direct bilirubin ≤ 7 μmol/L (≤ 0.4 mg/dL). Key
Exclusion criteria
* 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. * Hepatitis B virus (HBV) surface antigen (HBsAg) positive or HBV core antibody (antibody against hepatitis B core antigen (anti-HBc)) positive; if individual is HBsAg negative and anti-HBc positive but HBV DNA undetectable, individual may be enrolled. Note: Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic (PK) Parameter: Ctrough, W26 of Lenacapavir (LEN) | Week 26 | 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 | First dose date up to Week 26 | — |
| Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Through Week 26 | First dose date up to Week 26 | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in CD4+ Cell Counts at Week 52 | Baseline, Week 52 | — |
| Percent Change From Baseline in CD4+ at Week 26 | Baseline, Week 26 | — |
| PK Parameter: Cmax, D1-W26 of LEN | Day 1 up to Week 26 | 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 | Day 1 up to Week 26 | 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 | First dose date up to Week 52 | — |
| Percent Change From Baseline in CD4+ at Week 52 | Baseline, 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 | Week 26 | — |
| General Acceptability of Oral LEN as Assessed by Percentage of Participants With Acceptability Questionnaire Responses on Day 1 | 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. |
| General Acceptability of Oral LEN as Assessed by Percentage of Participants With Acceptability Questionnaire Responses on Day 2 | 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. |
| General Palatability of Oral LEN as Assessed by Percentage of Participants With Palatability Questionnaire Responses on Day 1 | 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. |
| General Palatability of Oral LEN as Assessed by Percentage of Participants With Palatability Questionnaire Responses on Day 2 | 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. |
| Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Through Week 52 | First dose date up to Week 52 | — |
| Percentage of Participants with Plasma HIV-1 RNA < 50 Copies/mL at Week 52 Based on the US FDA-Defined Snapshot Algorithm | Week 52 | — |
| Change From Baseline in Clusters of Differentiation (CD4)+ Cell Counts at Week 26 | Baseline, Week 26 | — |
Countries
South Africa, United States
Contacts
Primary ContactGilead Clinical Study Information Center
Outcome results
None listed