NCT06749054 · Gilead Sciences
Evaluation of Long-Acting Lenacapavir for the Treatment of HIV-1 in Treatment-experienced Adolescents and Children
What this study is about
The goal of this clinical study is to learn more about the study drug, lenacapavir (LEN). The study will assess the safety, tolerability, and effectiveness 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.
View original scientific description
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
DRUG
Oral Lenacapavir
Tablets administered without regard to food
DRUG
Subcutaneous Lenacapavir
Administered via subcutaneous injections
DRUG
Optimized Background Regimen (OBR)
Optimized background regimen as prescribed by the Investigator
Primary outcome measures
Pharmacokinetic (PK) Parameter: Ctrough, W26 of Lenacapavir (LEN)
Time frame: 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
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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:
- Estimated glomerular filtration rate (eGFR) ≥ 60 mL/min/1.73 m\^2 using Bedside Schwartz Formula.
- Absolute neutrophil count \> 0.50 GI/L (\> 500 cells/mm\^3).
- Hemoglobin ≥ 85 g/L (\> 8.5 g/dL).
- Platelets ≥ 50 GI/L (≥ 50,000/mm\^3).
- Hepatic transaminases (aspartate aminotransferase and alanine aminotransferase) ≤ 5 × upper limit of normal.
- 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/Exclusion criteria may apply.
Where
- Atlanta, Georgia
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 24, 2026 · Source of record for eligibility and locations