deltatrials
Completed PHASE1/PHASE2 INTERVENTIONAL 3-arm NCT01504841

Evaluating the Safety and Tolerability of Etravirine in HIV-1 Infected Infants and Children

A Phase I/II, Open-Label Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of Etravirine (ETR) in Antiretroviral (ARV) Treatment-Experienced HIV-1 Infected Infants and Children, Aged ≥ 2 Months to < 6 Years

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Conditions HIV Infections
Interventions Etravirine (ETR)
Updated 16 times since 2017 Last updated: Oct 29, 2021 Started: Mar 14, 2013 Primary completion: Jul 17, 2018 Completion: Aug 26, 2020
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT01504841, this PHASE1/PHASE2 trial focuses on HIV Infections and remains completed. Sponsored by National Institute of Allergy and Infectious Diseases (NIAID), it has been updated 16 times since 2013, reflecting substantial change activity. This study is part of the global effort to build evidence for infectious disease interventions.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshot~Feb 2017 – ~Oct 2017 · 8 months · monthly snapshot~Oct 2017 – ~Dec 2017 · 2 months · monthly snapshot~Dec 2017 – ~Jan 2018 · 31 days · monthly snapshot~Jan 2018 – ~Jun 2018 · 5 months · monthly snapshot~Jun 2018 – ~Sep 2018 · 3 months · monthly snapshot~Sep 2018 – ~Oct 2019 · 13 months · monthly snapshot~Oct 2019 – ~Oct 2020 · 12 months · monthly snapshot~Oct 2020 – ~Jan 2021 · 3 months · monthly snapshot~Jan 2021 – ~Sep 2021 · 8 months · monthly snapshot~Sep 2021 – ~Oct 2021 · 30 days · monthly snapshot~Oct 2021 – ~Dec 2021 · 2 months · monthly snapshot~Dec 2021 – ~Jul 2024 · 31 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshot~Sep 2025 – present · 10 months · monthly snapshot

Change History

16 versions recorded

  1. Sep 2025 — Present [monthly]

    Completed PHASE1/PHASE2

  2. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE1/PHASE2

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE1/PHASE2

    Phase: PHASE1_PHASE2 → PHASE1/PHASE2

  4. Dec 2021 — Jul 2024 [monthly]

    Completed PHASE1_PHASE2

  5. Oct 2021 — Dec 2021 [monthly]

    Completed PHASE1_PHASE2

▶ Show 11 earlier versions

  1. Sep 2021 — Oct 2021 [monthly]

    Completed PHASE1_PHASE2

  2. Jan 2021 — Sep 2021 [monthly]

    Completed PHASE1_PHASE2

  3. Oct 2020 — Jan 2021 [monthly]

    Completed PHASE1_PHASE2

    Status: Active Not Recruiting → Completed

  4. Oct 2019 — Oct 2020 [monthly]

    Active Not Recruiting PHASE1_PHASE2

  5. Sep 2018 — Oct 2019 [monthly]

    Active Not Recruiting PHASE1_PHASE2

  6. Jun 2018 — Sep 2018 [monthly]

    Active Not Recruiting PHASE1_PHASE2

  7. Jan 2018 — Jun 2018 [monthly]

    Active Not Recruiting PHASE1_PHASE2

  8. Dec 2017 — Jan 2018 [monthly]

    Active Not Recruiting PHASE1_PHASE2

    Status: Recruiting → Active Not Recruiting

  9. Oct 2017 — Dec 2017 [monthly]

    Recruiting PHASE1_PHASE2

  10. Feb 2017 — Oct 2017 [monthly]

    Recruiting PHASE1_PHASE2

  11. Jan 2017 — Feb 2017 [monthly]

    Recruiting PHASE1_PHASE2

    First recorded

Mar 2013

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • National Institute of Allergy and Infectious Diseases (NIAID)
Data source: National Institute of Allergy and Infectious Diseases (NIAID)

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

Study Locations