deltatrials
Completed PHASE2 INTERVENTIONAL 1-arm NCT00534352

A Study to Evaluate the Pharmacokinetic Profile (How the Body Absorbs, Distributes, Metabolizes and Eliminates a Drug) of TMC125 Plus Tenofovir/Emtricitabine Once Daily With or Without Darunavir/r Once Daily in Antiretroviral (ARV) Naive HIV-1 Patients (Patients Have Never Received ARV Treatment).

A Multicenter Study to Evaluate the Pharmacokinetic Profile and Safety of TMC125 Plus Tenofovir DF/Emtricitabine All Dosed Once Daily With and Without Darunavir (PREZISTA™)/ Ritonavir Once Daily in Antiretroviral naïve HIV-1 Infected Subjects

Sponsor: Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA

Updated 6 times since 2017 Last updated: Mar 26, 2015 Started: Jan 31, 2008 Primary completion: May 31, 2008 Completion: Mar 31, 2009
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE2 clinical study on HIV-1 Infection, this trial is completed. The trial is conducted by Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA and has accumulated 6 data snapshots since 2008. Infectious disease trials contribute critical data for public health response and treatment development.

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 – present · 22 months · monthly snapshotCompleted

Change History

6 versions recorded
  1. Sep 2024 — Present [monthly]

    Completed PHASE2

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE2

  3. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE2

  4. Jun 2018 — Jan 2021 [monthly]

    Completed PHASE2

  5. Feb 2017 — Jun 2018 [monthly]

    Completed PHASE2

Show 1 earlier version
  1. Jan 2017 — Feb 2017 [monthly]

    Completed PHASE2

    First recorded

Jan 2008

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA
  • Tibotec, Inc
Data source: Tibotec, Inc

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

Study Locations

No location information available.