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NCT00896051 · ClinicalTrials.gov registry record · Phase 2

TMC125-TiDP2-C238: An Exploratory Pharmacokinetics, Safety and Anti-HIV Activity Study of Etravirine (ETR) When Given With Boosted Atazanavir (ATV/Rtv) at Two Different Doses and 1 Nucleoside Reverse Transcriptase Inhibitor (NRTI) in Treatment Experienced HIV Patients

A Phase 2 study, sponsored by Janssen R&D Ireland.

Completed
Registry status
Phase 2
Development phase
50
Enrollment target

NCT00896051 is a Phase 2 study that has completed, run by Janssen R&D Ireland. The registered enrollment target is 50 participants.

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The verdict

NCT00896051, a Phase 2 study, has completed, sponsored by Janssen R&D Ireland.

COMPLETED
Registry status
Phase 2
Development phase
50 participants
Enrollment target

Study Summary

The purpose of this study is to determine the pharmacokinetics (how the body absorbs, distributes, metabolizes and eliminates a drug) (PK) of ETR when given with ATV/rtv and 1 NRTI in treatment experienced HIV-1 infected patients. In addition, safety, tolerability and anti-HIV effect of this regimen will also be studied. A total of 46 patients will be enrolled.

Interventions

  • DRUG Atazanavir (ATV) 300 mg
  • DRUG Atazanavir (ATV) 400 mg
  • DRUG Ritonavir (rtv) 100 mg
  • DRUG Nucleo(side)/(tide) reverse transcriptase inhibitors (NRTIs)
  • DRUG Etravirine (ETR) 200 mg

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2009-08
Est. Completion 2012-04
Phase Phase 2

Sponsor

Janssen R&D Ireland

14 total trials

What the Registry Record Tells You About NCT00896051

The ClinicalTrials.gov registry entry for NCT00896051 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen R&D Ireland, which has 14 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 5 interventions - of which Atazanavir (ATV) 300 mg is the first listed.

NCT00896051 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00896051 about?

NCT00896051 is a clinical study titled "TMC125-TiDP2-C238: An Exploratory Pharmacokinetics, Safety and Anti-HIV Activity Study of Etravirine (ETR) When Given With Boosted Atazanavir (ATV/Rtv) at Two Different Doses and 1 Nucleoside Reverse Transcriptase Inhibitor (NRTI) in Treatment Experienced HIV Patients". The purpose of this study is to determine the pharmacokinetics (how the body absorbs, distributes, metabolizes and eliminates a drug) (PK) of ETR when given with ATV/rtv and 1 NRTI in treatment experienced HIV-1 infected patients. In addition, safety, tolerability and anti-HIV effect of this regimen...

What is the current status of trial NCT00896051?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2009-08. Estimated completion is 2012-04.

What interventions are being tested in trial NCT00896051?

The interventions under investigation include: Atazanavir (ATV) 300 mg (DRUG), Atazanavir (ATV) 400 mg (DRUG), Ritonavir (rtv) 100 mg (DRUG), Nucleo(side)/(tide) reverse transcriptase inhibitors (NRTIs) (DRUG), Etravirine (ETR) 200 mg (DRUG).

Who is sponsoring clinical trial NCT00896051?

This trial is sponsored by Janssen R&D Ireland, which has 14 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.