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Completed Phase 3 Interventional

TMC114-C211: Trial of an Investigational Protease Inhibitor TMC114 With Ritonavir ("TMC114/r") in HIV-1 Infected Patients Who Have Never Been Treated With Antiretroviral Medications.

ClinicalTrials.gov ID: NCT00258557

Public ClinicalTrials.gov record NCT00258557. 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.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 6:25 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Phase III Randomized, Controlled, Open-label Trial to Investigate the Antiviral Activity, Tolerability and Safety of TMC114/r in Treatment- Naive HIV-1 Infected Patients.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The purpose of this study is to compare the efficacy, safety and tolerability of TMC114/r versus Kaletra (a combination pill of lopinavir and ritonavir, ("lpv/rtv") in HIV-1 infected patients who have never been treated with anti-retroviral medications (referred to as "treatment-naïve" patients).

Study identification

NCT ID
NCT00258557
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Enrollment
692 participants

Conditions and interventions

Conditions

Interventions

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
Aug 31, 2005
Primary completion
May 31, 2007
Completion
Apr 30, 2012
Last update posted
Jun 25, 2013

2005 – 2012

United States locations

U.S. sites
24
U.S. states
12
U.S. cities
24
Facility City State ZIP Site status
Not listed Phoenix Arizona
Not listed Beverly Hills California
Not listed Long Beach California
Not listed Los Angeles California
Not listed Sacramento California
Not listed San Francisco California
Not listed Washington D.C. District of Columbia
Not listed Fort Lauderdale Florida
Not listed Jacksonville Florida
Not listed Miami Florida
Not listed Miami Beach Florida
Not listed Orlando Florida
Not listed Safety Harbor Florida
Not listed Tampa Florida
Not listed Vero Beach Florida
Not listed Baltimore Maryland
Not listed Boston Massachusetts
Not listed Las Vegas Nevada
Not listed Brooklyn New York
Not listed Chapel Hill North Carolina
Not listed Winston-Salem North Carolina
Not listed Philadelphia Pennsylvania
Not listed Columbia South Carolina
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 65 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00258557, 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 Jun 25, 2013 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00258557 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →