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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 Oct 22, 2026, 5:45 PM 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
Sep 2005 (Type not available)
Primary completion
Jun 2007 (Actual)
Completion
May 2012 (Actual)
Last update posted
Jun 26, 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 26, 2013 · Synced Oct 22, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00258557 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →