Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 2 study, sponsored by Janssen R&D Ireland.
NCT00896051 is a Phase 2 study that has completed, run by Janssen R&D Ireland. The registered enrollment target is 50 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The table below shows pharmacokinetic (PK) results of atazanavir (ATZ) when administered as ATV/rtv 300/100 mg pretreatment (Reference) and at Week 2 after treatment (Test). Results are expressed as the predose plasma concentration (C0h), minimum plasma concentration (Cmin), and maximum plasma concentration (Cmax).
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 |
What the finished NCT00896051 record still lists
NCT00896051 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 5 interventions - of which Atazanavir (ATV) 300 mg is the first listed.
NCT00896051 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00896051's enrollment target sits among peer trials
50 1195th of 2000 higher than 740 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00200889 · 50 participants · Early Phase 1
Mapping Auricular Vagus Nerve Circuitry
- NCT00409435 · 50 participants · Phase 2
A Study of Pyridostigmine in Postural Tachycardia Syndrome
- NCT01202305 · 50 participants
The Use of Lymph Node Biopsies to Support HIV Pathogenesis Studies
- NCT01225913 · 50 participants · Phase 4
Mechanism(s) of Airflow Limitation During Exacerbation of Asthma
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia