Actively Recruiting
Evaluation of Long-Acting Lenacapavir for the Treatment of HIV-1 in Treatment-experienced Adolescents and Children
Led by Gilead Sciences · Updated on 2026-04-24
12
Participants Needed
9
Research Sites
127 weeks
Total Duration
On this page
AI-Summary
What this Trial 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 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.
CONDITIONS
Official Title
Evaluation of Long-Acting Lenacapavir for the Treatment of HIV-1 in Treatment-experienced Adolescents and Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Body weight at screening 235 kg.
- Currently on a stable failing antiretroviral regimen for more than 8 weeks before screening and willing to continue it until Day 1.
- Plasma HIV-1 RNA 2400 copies/mL on at least 2 occasions over 6 months, including at screening.
- Have changed their antiretroviral regimen before due to treatment failure.
- Limited antiretroviral treatment options due to resistance, tolerability, contraindications, safety, or drug access.
- Able and willing to take lenacapavir combined with their optimized background regimen.
- Laboratory values at screening must meet: estimated glomerular filtration rate 260 mL/min/1.73 m2, absolute neutrophil count 200 cells/mm3, hemoglobin 2 g/dL, platelets 250,000/mm3, hepatic transaminases 25 times upper limit of normal, total bilirubin 1.5 mg/dL, and direct bilirubin 0.4 mg/dL.
You will not qualify if you...
- Life expectancy less than or equal to 1 year.
- Having an opportunistic illness requiring treatment within 30 days prior to screening.
- Evidence of active pulmonary or extra-pulmonary tuberculosis within 3 months prior to screening.
- Positive for hepatitis C antibody with detectable hepatitis C RNA at screening.
- Positive for hepatitis B surface antigen or hepatitis B core antibody; if negative for surface antigen but positive for core antibody, must have undetectable hepatitis B DNA.
- Other protocol-defined inclusion or exclusion criteria may apply.
AI-Screening
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Trial Site Locations
Total: 9 locations
1
Grady Health System, Ponce De Leon Center
Atlanta, Georgia, United States, 30308
Actively Recruiting
2
FAMCRU
Cape Town, South Africa, 7505
Actively Recruiting
3
CRISMO Research Centre
Germiston, South Africa, 1401
Actively Recruiting
4
Wits RHI Shandukani Research Centre CRS
Johannesburg, South Africa, 2038
Actively Recruiting
5
Rahima Moosa Mother and Child Hospital
Johannesburg, South Africa, 2112
Actively Recruiting
6
Clinical Research Institute of South Africa (CRISA)
KwaDukuza, South Africa, 4449
Actively Recruiting
7
Durban International Clinical Research Site, Enhancing Care Foundation
KwaZulu - Natal, South Africa, 4093
Actively Recruiting
8
Be Part Research Pty (Ltd)
Paarl, South Africa, 7626
Actively Recruiting
9
Perinatal HIV Research Unit (PHRU)
Soweto, South Africa, 2013
Withdrawn
Research Team
G
Gilead Clinical Study Information Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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