deltatrials
Completed PHASE2 INTERVENTIONAL 1-arm NCT00919854

A Safety Study to Evaluate the Antiviral Activity of Darunavir in Combination With Ritonavir in HIV 1 Infected Children

A Phase II, Open Label Trial, to Evaluate Pharmacokinetics, Safety, Tolerability and Antiviral Activity of DRV in Combination With Low-Dose Ritonavir (DRV/Rtv) in Treatment-Experienced HIV-1 Infected Children From 3 Years to Below 6 Years of Age

Sponsor: Tibotec Pharmaceutical Limited

Updated 8 times since 2017 Last updated: Apr 3, 2014 Started: Sep 30, 2009 Primary completion: Aug 31, 2010 Completion: Feb 28, 2011
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE2 trial investigates Human Immunodeficiency Virus 1 and is currently completed. Tibotec Pharmaceutical Limited leads this study, which shows 8 recorded versions since 2009 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotCompleted~Feb 2017 – ~Jun 2018 · 16 months · monthly snapshotCompleted~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotCompleted~Sep 2025 – present · 7 months · monthly snapshotCompleted~Jan 2026 – present · 3 months · monthly snapshotCompleted

Change History

8 versions recorded
  1. Jan 2026 — Present [monthly]

    Completed PHASE2

  2. Sep 2025 — Present [monthly]

    Completed PHASE2

  3. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE2

  4. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE2

  5. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE2

Show 3 earlier versions
  1. Jun 2018 — Jan 2021 [monthly]

    Completed PHASE2

  2. Feb 2017 — Jun 2018 [monthly]

    Completed PHASE2

  3. Jan 2017 — Feb 2017 [monthly]

    Completed PHASE2

    First recorded

Sep 2009

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Tibotec Pharmaceutical Limited
  • Tibotec Pharmaceuticals, Ireland
Data source: Tibotec Pharmaceuticals, Ireland

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