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HIV-1-infectionPhase 2NCT06749054

Evaluation of Long-Acting Lenacapavir for the Treatment of HIV-1 in Treatment-experienced Adolescents and Children

A Phase 2 study testing Oral Lenacapavir, Subcutaneous Lenacapavir and Optimized Background Regimen (OBR) in people with HIV-1-infection, run by Gilead Sciences at 9 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages Up to 17 years
Conditions the study is for
HIV-1-infection
What is being tested?
Oral Lenacapavir, Subcutaneous Lenacapavir and Optimized Background Regimen (OBR)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
9 sitesin 2 countries
Study dates
26 Mar 2025to Sep 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.
Show all 13Show fewer
  • 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).

Who cannot join

  • 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.

Trial locations and contacts

9 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Gilead Clinical Study Information Center contact

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

GileadClinicalTrials@gilead.com

9 sites in 2 countries

South Africa8 sites, 7 recruiting

  • FAMCRU

    Cape Town, 7505

    Recruiting

  • CRISMO Research Centre

    Germiston, 1401

    Recruiting

  • Wits RHI Shandukani Research Centre CRS

    Johannesburg, 2038

    Recruiting

  • Rahima Moosa Mother and Child Hospital

    Johannesburg, 2112

    Recruiting

  • Clinical Research Institute of South Africa (CRISA)

    KwaDukuza, 4449

    Recruiting

  • Durban International Clinical Research Site, Enhancing Care Foundation

    KwaZulu - Natal, 4093

    Recruiting

  • Be Part Research Pty (Ltd)

    Paarl, 7626

    Recruiting

  • Perinatal HIV Research Unit (PHRU)

    Soweto, 2013

    Withdrawn

Other trials in South Africa

United States1 site, 1 recruiting

  • Grady Health System, Ponce De Leon Center

    Atlanta, Georgia, 30308

    Recruiting

Other trials in United States

About this study

Official title: 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

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
HIV-1-infection
Being tested
Oral Lenacapavir, Subcutaneous Lenacapavir, Optimized Background Regimen (OBR)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Oral LenacapavirDrug

    Also called GS-6207, Sunlenca®

    Tablets administered without regard to food

  • Subcutaneous LenacapavirDrug

    Also called GS-6207, Sunlenca®

    Administered via subcutaneous injections

  • Optimized Background Regimen (OBR)Drug

    Optimized background regimen as prescribed by the Investigator

Study groups in NCT06749054
Study groupRoleWhat they receive
LENExperimentalParticipants will receive oral LEN 600 mg on Days 1 and 2. Participants will also receive 2 doses of LEN 927 mg as subcutaneous (SC) injection on Day 1 and Week 26 along with their OBR per clinical practice. At the Week 52, participants will be given the option to receive SC LEN every 6 months while continuing their OBR for at least another 2 SC LEN doses in the extension phase.
Receives: Drug: Oral Lenacapavir; Drug: Subcutaneous Lenacapavir; Drug: Optimized Background Regimen (OBR)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pharmacokinetic (PK) Parameter: Ctrough, W26 of Lenacapavir (LEN)

    Ctrough, W26 is defined as the plasma concentration at the end of the dosing interval at Week 26.

    Measured: Week 26

  2. Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) Through Week 26

    Measured: First dose date up to Week 26

  3. Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Through Week 26

    Measured: First dose date up to Week 26

Secondary outcomes (14)

  1. PK Parameter: Cmax, D1-W26 of LEN

    Cmax, D1-W26 is defined as the maximum observed concentration of drug from Day 1 to Week 26.

    Measured: Day 1 up to Week 26

  2. PK Parameter: AUC D1-W26 of LEN

    AUC D1-W26 is defined as the partial area under the concentration versus time curve from Day 1 to Week 26.

    Measured: Day 1 up to Week 26

  3. Percentage of Participants Experiencing Treatment-Emergent AEs Through Week 52

    Measured: First dose date up to Week 52

  4. Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Through Week 52

    Measured: First dose date up to Week 52

  5. 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

    Measured: Week 26

  6. Percentage of Participants with Plasma HIV-1 RNA < 50 Copies/mL at Week 52 Based on the US FDA-Defined Snapshot Algorithm

    Measured: Week 52

  7. Change From Baseline in Clusters of Differentiation (CD4)+ Cell Counts at Week 26

    Measured: Baseline, Week 26

  8. Change From Baseline in CD4+ Cell Counts at Week 52

    Measured: Baseline, Week 52

  9. Percent Change From Baseline in CD4+ at Week 26

    Measured: Baseline, Week 26

  10. Percent Change From Baseline in CD4+ at Week 52

    Measured: Baseline, Week 52

  11. General Acceptability of Oral LEN as Assessed by Percentage of Participants With Acceptability Questionnaire Responses on 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.

    Measured: Day 1

  12. General Acceptability of Oral LEN as Assessed by Percentage of Participants With Acceptability Questionnaire Responses on 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.

    Measured: Day 2

  13. General Palatability of Oral LEN as Assessed by Percentage of Participants With Palatability Questionnaire Responses on 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.

    Measured: Day 1

  14. General Palatability of Oral LEN as Assessed by Percentage of Participants With Palatability Questionnaire Responses on 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.

    Measured: Day 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Dec 2024
  2. Study start26 Mar 2025
  3. Primary completionMar 2027 (estimated)
  4. Study completionSep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06749054
Sponsor's protocol ID
GS-US-200-6712
Status last verified
Apr 2026
First submitted
19 Dec 2024
Last updated
24 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Oral Lenacapavir, Subcutaneous Lenacapavir and Optimized Background Regimen (OBR) in people with HIV-1-infection, run by Gilead Sciences at 9 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in South Africa, United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Gilead Clinical Study Information Center (1-833-445-3230 (GILEAD-0), GileadClinicalTrials@gilead.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pharmacokinetic (PK) Parameter: Ctrough, W26 of Lenacapavir (LEN) (time frame: Week 26). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06749054.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.

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