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
Public ClinicalTrials.gov record NCT00896051. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
TMC125-TiDP2-C238: A Randomized, Exploratory, Open-label 48-week Trial to Investigate the Pharmacokinetics, Safety, Tolerability and Antiviral Activity of Etravirine (ETR) in Combination With Ritonavir-boosted Atazanavir (ATV/Rtv) and 1 NRTI in Treatment-experienced HIV-1 Infected Subjects
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00896051
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 50 participants
Conditions and interventions
Conditions
Interventions
- 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
- Tenofovir disoproxil fumarate (TDF) 300 mg Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 31, 2009
- Primary completion
- Mar 31, 2012
- Completion
- Mar 31, 2012
- Last update posted
- Sep 29, 2013
2009 – 2012
United States locations
- U.S. sites
- 10
- U.S. states
- 5
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Little Rock | Arkansas | — | — |
| Not listed | Bakersfield | California | — | — |
| Not listed | Beverly Hills | California | — | — |
| Not listed | Orlando | Florida | — | — |
| Not listed | Tampa | Florida | — | — |
| Not listed | Vero Beach | Florida | — | — |
| Not listed | West Palm Beach | Florida | — | — |
| Not listed | Macon | Georgia | — | — |
| Not listed | Dallas | Texas | — | — |
| Not listed | Houston | Texas | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 8 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00896051, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 29, 2013 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00896051 live on ClinicalTrials.gov.