A Study of TMC278 in Human Immunodeficiency Virus Type 1 Infected Patients, Who Are Not Treated With Antiretroviral Medicines

Phase 2 Completed 368 enrolled Tibotec Pharmaceuticals, Ireland

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to evaluate the dose-response relationship of antiviral activity after 48 weeks treatment with 3 different dose regimens of TMC278.

Timeline

Start: 2005-06
Primary completion: 2011-12
Completion: 2011-12

Outcome

Missed primary endpoint

registry analysis (superiority or other test); All TMC278 vs Efavirenz; p = 0.80; Difference in response rate -1.5 (95% CI -10.5 to 7.5); NCT00110305 ↗

Publications

Pozniak AL, Morales-Ramirez J, Katabira E, Steyn D, Lupo SH, Santoscoy M, Grinsztejn B, Ruxrungtham K, Rimsky LT, Vanveggel S, Boven K; TMC278-C204 Study Group. Efficacy and safety of TMC278 in antiretroviral-naive HIV-1 patients: week 96 results of a phase IIb randomized trial. AIDS. 2010 Jan 2;24(1):55-65. doi: 10.1097/QAD.0b013e32833032ed.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Efavirenz	Other / unclassified	600 mg	—
Subject	Rilpivirine	Small molecule	25 mg	—
Subject	Rilpivirine	Small molecule	75 mg	—
Subject	Rilpivirine	Small molecule	150 mg	—
Background	Lamivudine	Other / unclassified	—	—
Background	Tenofovir disoproxil fumarate	Small molecule	—	—
Background	Zidovudine	Small molecule	—	—
Background	emtricitabine	Other / unclassified	—	—