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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.
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
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2009-08 |
| Est. Completion | 2012-04 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗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.
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