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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
Efficacy and safety of TMC278 in antiretroviral-naive HIV-1 patients: Week 96 results of a phase IIb randomized trial
AIDS, Volume 24, No. 1, Year 2010
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Description
Objective: TMC278 is a next-generation nonnucleoside reverse transcriptase inhibitor highly active against wild-type and nonnucleoside reverse transcriptase inhibitor-resistant HIV-1 in vitro. The week 96 analysis of TMC278-C204, a large dose-ranging study of TMC278 in treatment-naive HIV-1-infected patients, is presented. Design: Phase IIb randomized trial. Methods: Three hundred sixty-eight patients were randomized and treated with three blinded once-daily TMC278 doses 25, 75 or 150 mg, or an open-label, active control, efavirenz 600 mg once daily, all with two nucleoside reverse transcriptase inhibitors. The primary analysis was at week 48. Results: No TMC278 dose-response relationship for efficacy and safety was observed. TMC278 demonstrated potent antiviral efficacy comparable with efavirenz over 48 weeks that was sustained to week 96 (76.9-80.0% and 71.4-76.3% of TMC278-treated patients with confirmed viral load <50 copies/ml, respectively; time-to-loss of virological-response algorithm). Median increases from baseline in CD4 cell count with TMC278 at week 96 (138.0-149.0 cells/μl) were higher than at week 48 (108.0-123.0 cells/μl). All TMC278 doses were well tolerated. The incidences of the most commonly reported grade 2-4 adverse events at least possibly related to study medication, including nausea, dizziness, abnormal dreams/nightmare, dyspepsia, asthenia, rash, somnolence and vertigo, were low and lower with TMC278 than with efavirenz. Incidences of serious adverse events, grade 3 or 4 adverse events and discontinuations due to adverse events were similar among groups. Conclusion: All TMC278 doses demonstrated potent and sustained efficacy comparable with efavirenz in treatment-naive patients over 96 weeks. TMC278 was well tolerated with lower incidences of neurological and psychiatric adverse events, rash and lower lipid elevations than those with efavirenz. TMC278 25 mg once daily was selected for further clinical development. © 2010 Wolters Kluwer Health | Lippincott Williams & Wilkins.
Authors & Co-Authors
Pozniak, Anton Louis
United Kingdom, London
Chelsea and Westminster Hospital Nhs Foundation Trust
Morales-Ramirez, Javier
Puerto Rico, San Juan
Fdi Clinical Research of Puerto Rico
Katabira, Elly Tebasoboke
Uganda, Kampala
Makerere University
Steyn, Dewald
South Africa, Bloemfontein
University of the Free State
Lupo, Sergio Horacio
Argentina, Rosario
Universidad Nacional de Rosario
Santoscoy, Mario
Mexico, Mexico
Instituto Mexicano Del Seguro Social
Grinsztejn, Beatriz Gilda Jegerhorn
Brazil, Rio de Janeiro
Instituto Nacional de Infectologia Evandro Chagas Ini
Ruxrungtham, Kiat
Thailand, Bangkok
Chulalongkorn University
Rimsky, Laurence T.
Belgium, Machelen
Tibotec Bvba
Vanveggel, Simon
Belgium, Machelen
Tibotec Bvba
Boven, Katia J.
United States, Philadelphia
Tibotec Inc.
Statistics
Citations: 103
Authors: 11
Affiliations: 10
Identifiers
Doi:
10.1097/QAD.0b013e32833032ed
e-ISSN:
14735571
Research Areas
Infectious Diseases
Mental Health