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Completed Phase 3 Interventional

TMC125-C206: A Phase III Study to Investigate the Efficacy, Tolerability and Safety of TMC125 as Part of an Antiretroviral Regimen, Including TMC114/Ritonavir and an Investigator-selected Optimized Background, in HIV-1 Infected Patients With Limited to no Treatment Options.

ClinicalTrials.gov ID: NCT00254046

Public ClinicalTrials.gov record NCT00254046. 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, 11:48 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

A Phase III Randomized, Double-blinded, Placebo-controlled Trial to Investigate the Efficacy, Tolerability and Safety of TMC125 as Part of an ART Regimen, Including TMC114/RTV and an Investigator-selected OBR, in HIV-1 Infected Patients With Limited Treatment to no Treatment Options.

Brief summary

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

The purpose of this study is research with the goal of evaluating the effect of TMC125 (a non-nucleoside reverse transcriptase inhibitor) on slowing down the growth of the HIV virus. The study will also investigate whether this new medication is well tolerated, and to further confirm that the medication is safe to be used.

Study identification

NCT ID
NCT00254046
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Enrollment
616 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
Oct 31, 2005
Primary completion
Jan 31, 2007
Completion
Jun 30, 2008
Last update posted
Jun 19, 2014

2005 – 2008

United States locations

U.S. sites
32
U.S. states
16
U.S. cities
32
Facility City State ZIP Site status
Not listed Little Rock Arkansas
Not listed Beverly Hills California
Not listed Los Angeles California
Not listed San Diego California
Not listed San Francisco California
Not listed New Haven Connecticut
Not listed Washington D.C. District of Columbia
Not listed Fort Lauderdale Florida
Not listed Miami Florida
Not listed North Miami Beach Florida
Not listed Pensacola Florida
Not listed Safety Harbor Florida
Not listed Tampa Florida
Not listed Vero Beach Florida
Not listed Atlanta Georgia
Not listed Macon Georgia
Not listed Wichita Kansas
Not listed Boston Massachusetts
Not listed Newark New Jersey
Not listed Santa Fe New Mexico
Not listed New York New York
Not listed The Bronx New York
Not listed Huntersville North Carolina
Not listed Winston-Salem North Carolina
Not listed Portland Oregon
Not listed Philadelphia Pennsylvania
Not listed Austin Texas
Not listed Dallas Texas
Not listed Galveston Texas
Not listed Houston Texas
Not listed Longview Texas
Not listed Annandale Virginia

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 23 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00254046, 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 19, 2014 · Synced Sep 2, 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 protocol, eligibility criteria, and contact information for NCT00254046 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →