NCT00255099

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

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

Enrollment
593

participants targeted

Target at P50-P75 for phase_3 hiv

Timeline
Completed

Started Dec 2005

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

First Submitted

Initial submission to the registry

November 15, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 17, 2005

Completed
14 days until next milestone

Study Start

First participant enrolled

December 1, 2005

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

June 15, 2011

Status Verified

June 1, 2011

Enrollment Period

1.1 years

First QC Date

November 15, 2005

Last Update Submit

June 2, 2011

Conditions

HIV

Keywords

HIVHIV-1TMC125

Outcome Measures

Primary Outcomes (1)

  • Evaluation of efficacy, tolerability and safety of TMC125 as part of an antiretroviral therapy containing TMC114/ritonavir and an investigator selected optimized background regimen.

Study Arms (2)

001

ACTIVE COMPARATOR

TMC125 2 x 100 mg tablets b.i.d. / 96 weeks

Drug: TMC125

002

PLACEBO COMPARATOR

Placebo 2 tablets b.i.d. / 96 weeks

Drug: Placebo

Interventions

TMC125DRUG

2 x 100 mg tablets b.i.d. / 96 weeks

001
PlaceboDRUG

2 tablets b.i.d. / 96 weeks

002

Eligibility Criteria

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

You may qualify if:

  • Patient has 3 or more primary protease inhibitor mutations
  • documented genotypic evidence of resistance to currently available NNRTIs (non-nucleoside reverse transcriptase inhibitors) by having at least 1 NNRTI resistance-associated mutation
  • on a stable antiretroviral therapy for at least 8 weeks
  • plasma viral load at screening visit \> 5000 HIV-1 RNA copies/mL.

You may not qualify if:

  • Active AIDS defining illnesses (except for stable, cutaneous Kaposi's Sarcoma or wasting syndrome)
  • Any grade 3 or grade 4 toxicity according to the DAIDS grading scale
  • Use of disallowed concurrent therapy
  • Any active clinically significant disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • Katlama C, Haubrich R, Lalezari J, Lazzarin A, Madruga JV, Molina JM, Schechter M, Peeters M, Picchio G, Vingerhoets J, Woodfall B, De Smedt G; DUET-1, DUET-2 study groups. Efficacy and safety of etravirine in treatment-experienced, HIV-1 patients: pooled 48 week analysis of two randomized, controlled trials. AIDS. 2009 Nov 13;23(17):2289-300. doi: 10.1097/QAD.0b013e3283316a5e.

    PMID: 19710593RESULT

  • Kakuda TN, Wade JR, Snoeck E, Vis P, Scholler-Gyure M, Peeters MP, Corbett C, Nijs S, Vingerhoets J, Leopold L, De Smedt G, Woodfall BJ, Hoetelmans RM. Pharmacokinetics and pharmacodynamics of the non-nucleoside reverse-transcriptase inhibitor etravirine in treatment-experienced HIV-1-infected patients. Clin Pharmacol Ther. 2010 Nov;88(5):695-703. doi: 10.1038/clpt.2010.181. Epub 2010 Sep 29.

    PMID: 20881958DERIVED

  • Clotet B, Clumeck N, Katlama C, Nijs S, Witek J. Safety of etravirine in HIV-1/hepatitis B and/or C virus co-infected patients: pooled 96 week results from the Phase III DUET trials. J Antimicrob Chemother. 2010 Nov;65(11):2450-4. doi: 10.1093/jac/dkq332. Epub 2010 Aug 27.

    PMID: 20801782DERIVED

  • Vingerhoets J, Azijn H, Tambuyzer L, Dierynck I, De Meyer S, Rimsky L, Nijs S, De Smedt G, de Bethune MP, Picchio G. Short communication: activity of etravirine on different HIV type 1 subtypes: in vitro susceptibility in treatment-naive patients and week 48 pooled DUET study data. AIDS Res Hum Retroviruses. 2010 Jun;26(6):621-4. doi: 10.1089/aid.2009.0239.

    PMID: 20507207DERIVED

  • Lazzarin A, Campbell T, Clotet B, Johnson M, Katlama C, Moll A, Towner W, Trottier B, Peeters M, Vingerhoets J, de Smedt G, Baeten B, Beets G, Sinha R, Woodfall B; DUET-2 study group. Efficacy and safety of TMC125 (etravirine) in treatment-experienced HIV-1-infected patients in DUET-2: 24-week results from a randomised, double-blind, placebo-controlled trial. Lancet. 2007 Jul 7;370(9581):39-48. doi: 10.1016/S0140-6736(07)61048-4.

    PMID: 17617271DERIVED

Related Links

MeSH Terms

Interventions

etravirine

Study Officials

  • Tibotec Pharmaceuticals Clinical Trial

    Tibotec Pharmaceutical Limited

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 15, 2005

First Posted

November 17, 2005

Study Start

December 1, 2005

Primary Completion

January 1, 2007

Study Completion

July 1, 2008

Last Updated

June 15, 2011

Record last verified: 2011-06