NCT00081978

Brief Summary

The purpose of this study is to investigate the ability of TMC125, a Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI), to lower the amount of virus in your blood when administered twice daily for 48 weeks.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
211

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2004

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 28, 2004

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 30, 2004

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2005

Completed
Last Updated

April 28, 2010

Status Verified

April 1, 2010

First QC Date

April 28, 2004

Last Update Submit

April 26, 2010

Conditions

HIV Infection

Keywords

HIV infectionTMC125Non-nucleoside reverse transcriptase inhibitor, TMC125-C223

Outcome Measures

Primary Outcomes (1)

  • The primary objective of the trial is to evaluate the dose-response relationship of antiviral activity at 24 weeks within the two TMC125 dose regimens.

Secondary Outcomes (1)

  • Evaluate the antiviral activity, safety and tolerability of TMC125, immunologic changes, changes in viral genotype and drug suseptibility, PK of TMC125 and compare antiviral effect among treatment groups

Interventions

TMC125DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • HIV-1 plasma viral load at screening \>1000 copies/ml
  • Documented genotypic evidence of resistance to currently available NNRTIs
  • Previous NRTI experience for at least 3 months
  • primary PI mutations at screening

You may not qualify if:

  • Chronic HBV and/or HCV with elevated liver function tests \> 3x upper normal limits
  • Any grade 3 or 4 toxicity according to the ACTG grading severity list (except for grade 3 glucose and asymptomatic triglyceride/cholesterol grade 3 or 4 elevation)
  • Previous permanent discontinuation of any NNRTI due to cutaneous events.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Cohen CJ, Berger DS, Blick G, Grossman HA, Jayaweera DT, Shalit P, Thompson M, Peeters M, de Bethune MP, Voorspoels E, Mack R, Woodfall B. Efficacy and safety of etravirine (TMC125) in treatment-experienced HIV-1-infected patients: 48-week results of a phase IIb trial. AIDS. 2009 Jan 28;23(3):423-6. doi: 10.1097/QAD.0b013e32831c5040.

    PMID: 19114852RESULT

MeSH Terms

Conditions

HIV Infections

Interventions

etravirine

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Tibotec Pharmaceuticals Clinical Trial

    Tibotec Pharmaceutical Limited

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 28, 2004

First Posted

April 30, 2004

Study Start

March 1, 2004

Study Completion

October 1, 2005

Last Updated

April 28, 2010

Record last verified: 2010-04