Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
PlainTrials
RecruitingPhase 2interventionalRules rewrite

Phase 2: testing Oral Lenacapavir for HIV-1-infection

The goal of this clinical study is to learn more about the study drug, lenacapavir (LEN). The study will assess the safety, tolerability, and how well it works 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.

Official registry: https://clinicaltrials.gov/study/NCT06749054 · Gilead Sciences · enrollment listed as 12

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Oral Lenacapavir, Subcutaneous Lenacapavir, or Optimized Background Regimen (OBR). The registry lists allocation as na. The goal of this clinical study is to learn more about the study drug, lenacapavir (LEN).

They plan to enroll about 12 people at 9 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

A Phase 2, Open-label, Single-Arm Study to Evaluate the Pharmacokinetics, Safety, Tolerability, and Antiviral Activity of Long-Acting Lenacapavir in Combination With an Optimized Background Regimen in Treatment-experienced Adolescents and Children With HIV-1

Interventions: Oral Lenacapavir, Subcutaneous Lenacapavir, Optimized Background Regimen (OBR)

Primary outcome (registry wording): Pharmacokinetic (PK) Parameter: Ctrough, W26 of Lenacapavir (LEN)

Who it is for (from inclusion criteria)

  • Ages any to 17 Years
  • 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:

Public study contact (from the registry)

Gilead Clinical Study Information Center

1-833-445-3230 (GILEAD-0)

GileadClinicalTrials@gilead.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

9 listed

+ 8 sites outside the US on the same record

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FAQ about this NCT record

Is NCT06749054 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT06749054?

Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT06749054?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary