deltatrials
Recruiting PHASE1/PHASE2 INTERVENTIONAL 3-arm NCT05660980

Study of Oral and Long-Acting Injectable Cabotegravir and Rilpivirine in Virologically Suppressed Children Living With HIV-1, Two to Less Than 12 Years of Age

Phase I/II Study of the Safety, Tolerability, Acceptability, and Pharmacokinetics of Oral and Long-Acting Injectable Cabotegravir and Rilpivirine in Virologically Suppressed Children Living With HIV-1, Two to Less Than 12 Years of Age

Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Conditions HIV-1-infection
Interventions Long acting CAB injectable + long acting RPV injectable Once daily CAB tablet + RPV tablet
Updated 16 times since 2023 Last updated: May 23, 2025 Started: Jan 24, 2024 Primary completion: Jun 15, 2026 Completion: Jul 27, 2027
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE1/PHASE2 clinical study on HIV-1-infection, this trial is actively recruiting participants. The trial is conducted by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and has accumulated 16 data snapshots since 2024. Infectious disease trials contribute critical data for public health response and treatment development.

Status Flow

~Jan 2023 – ~Jul 2023 · 6 months · monthly snapshot~Jul 2023 – ~Sep 2023 · 2 months · monthly snapshot~Sep 2023 – ~Dec 2023 · 3 months · monthly snapshot~Dec 2023 – ~Jan 2024 · 31 days · monthly snapshot~Jan 2024 – ~Feb 2024 · 31 days · monthly snapshot~Feb 2024 – ~Apr 2024 · 2 months · monthly snapshot~Apr 2024 – ~Jun 2024 · 2 months · monthly snapshot~Jun 2024 – ~Jul 2024 · 30 days · monthly snapshot~Jul 2024 – ~Aug 2024 · 31 days · monthly snapshot~Aug 2024 – ~Sep 2024 · 31 days · monthly snapshot~Sep 2024 – ~Dec 2024 · 3 months · monthly snapshot~Dec 2024 – ~Jan 2025 · 31 days · monthly snapshot~Jan 2025 – ~Feb 2025 · 31 days · monthly snapshot~Feb 2025 – ~Jun 2025 · 4 months · monthly snapshot~Jun 2025 – ~Sep 2025 · 3 months · monthly snapshot~Sep 2025 – present · 10 months · monthly snapshot

Change History

16 versions recorded

  1. Sep 2025 — Present [monthly]

    Recruiting PHASE1/PHASE2

  2. Jun 2025 — Sep 2025 [monthly]

    Recruiting PHASE1/PHASE2

  3. Feb 2025 — Jun 2025 [monthly]

    Recruiting PHASE1/PHASE2

  4. Jan 2025 — Feb 2025 [monthly]

    Recruiting PHASE1/PHASE2

  5. Dec 2024 — Jan 2025 [monthly]

    Recruiting PHASE1/PHASE2

▶ Show 11 earlier versions

  1. Sep 2024 — Dec 2024 [monthly]

    Recruiting PHASE1/PHASE2

  2. Aug 2024 — Sep 2024 [monthly]

    Recruiting PHASE1/PHASE2

  3. Jul 2024 — Aug 2024 [monthly]

    Recruiting PHASE1/PHASE2

    Phase: PHASE1_PHASE2 → PHASE1/PHASE2

  4. Jun 2024 — Jul 2024 [monthly]

    Recruiting PHASE1_PHASE2

  5. Apr 2024 — Jun 2024 [monthly]

    Recruiting PHASE1_PHASE2

  6. Feb 2024 — Apr 2024 [monthly]

    Recruiting PHASE1_PHASE2

  7. Jan 2024 — Feb 2024 [monthly]

    Recruiting PHASE1_PHASE2

    Status: Not Yet Recruiting → Recruiting

  8. Dec 2023 — Jan 2024 [monthly]

    Not Yet Recruiting PHASE1_PHASE2

  9. Sep 2023 — Dec 2023 [monthly]

    Not Yet Recruiting PHASE1_PHASE2

  10. Jul 2023 — Sep 2023 [monthly]

    Not Yet Recruiting PHASE1_PHASE2

  11. Jan 2023 — Jul 2023 [monthly]

    Not Yet Recruiting PHASE1_PHASE2

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • National Institute of Allergy and Infectious Diseases (NIAID)
  • National Institute of Mental Health (NIMH)
Data source: National Institute of Allergy and Infectious Diseases (NIAID)

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations