Evaluation of Long-Acting Lenacapavir for the Treatment of HIV-1 in Treatment-experienced Adolescents and Children
Phase 2
12
about 2.1 years
≤17
1 site in GA
What this study is about
Researchers are testing a new treatment, lenacapavir (LEN), to see if it's safe and effective in children and adolescents who have already been treated for HIV. The trial will evaluate how well LEN works when combined with other medicines, either as an injection or an oral pill.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Receive Subcutaneous Lenacapavir
- 2.Take Optimized Background Regimen (OBR)
- 3.Take Oral Lenacapavir
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
Everyone gets the investigational treatment.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
lenacapavir
injection, subcutaneous, oral
Primary: Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) Through Week 26, Pharmacokinetic (PK) Parameter: Ctrough, W26 of Lenacapavir (LEN)
Secondary: Change From Baseline in CD4+ Cell Counts at Week 52, Change From Baseline in Clusters of Differentiation (CD4)+ Cell Counts at Week 26, PK Parameter: AUC D1-W26 of LEN, PK Parameter: Cmax, D1-W26 of LEN, Percent Change From Baseline in CD4+ at Week 26, Percent Change From Baseline in CD4+ at Week 52, Percentage of Participants Experiencing Treatment-Emergent AEs Through Week 52
Immune, Infectious