TMC125-C227: A Phase II Randomized, Active-Controlled, Open Label Trial to Investigate the Efficacy and Tolerability of TMC125 in HIV-1 Infected Subjects, Who Are PI-Naive and With Documented Genotypic Evidence of NNRTI Resistance From Previous NNRTI Use

Summary

The purpose of this study is to determinate the effectiveness, safety and tolerability (how well the body accepts the drug) of an investigational Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI) called TMC125.

Timeline

Start

2005-03

Primary completion

—

Completion

2006-06

Outcome

Missed primary endpoint

paper In an unplanned interim analysis, patients receiving TMC125 demonstrated suboptimal virological responses relative to the control PI. PMID 18795960 ↗

paper TMC125 was not as effective as first use of a PI. PMID 18795960 ↗

Publications

• Results Ruxrungtham K, Pedro RJ, Latiff GH, Conradie F, Domingo P, Lupo S, Pumpradit W, Vingerhoets JH, Peeters M, Peeters I, Kakuda TN, De Smedt G, Woodfall B; TMC125-C227 study group. Impact of reverse transcriptase resistance on the efficacy of TMC125 (etravirine) with two nucleoside reverse transcriptase inhibitors in protease inhibitor-naive, nonnucleoside reverse transcriptase inhibitor-experienced patients: study TMC125-C227. HIV Med. 2008 Nov;9(10):883-96. doi: 10.1111/j.1468-1293.2008.00644.x. Epub 2008 Sep 14.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Etravirine	Small molecule	200 mg	—

Indications