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

PHASE2CompletedINTERVENTIONAL
Enrollment

368

Participants

Timeline

Start Date

June 30, 2005

Primary Completion Date

December 31, 2011

Study Completion Date

December 31, 2011

Conditions
Human Immunodeficiency Virus Type 1
Interventions
DRUG

TMC278 25 mg

TMC278 25 mg tablet will be administered once daily.

DRUG

TMC278 75 mg

TMC278 75 mg (1 X 25 mg + 1 X 50 mg) tablets will be administered once daily.

DRUG

TMC278 150 mg

TMC278 150 mg (1 X 50 mg + 1 X 100 mg) tablets will be administered once daily.

DRUG

Efavirenz

Efavirenz 600 mg (1 x 600 mg tablet or 3 x 200 mg capsules, depending on formulation locally available) will be administered once daily.

DRUG

Non-nucleoside reverse transcriptase inhibitor (NRTIs)

Investigator selected 2 NRTIs: (1) Zidovudine and lamivudine (Combivir) and (2) tenofovir disoproxil fumarate and emtricitabine (Truvada) will be administered as per the package inserts, along with the TMC278 during the study period.

Trial Locations (40)

Unknown

Beverly Hills

Washington D.C.

Orlando

Tampa

Atlanta

Stony Brook

Winston-Salem

Addison

Seattle

Buenos Aires

Rosario

Vienna

Campinas

Curitiba

Pinheiros

Rio de Janeiro

São Paulo

Beijing

Paris

Tourcoing

Berlin

Cologne

Freiburg im Breisgau

München

Mexico City

San Juan

Kazan'

Moscow

Nizhny Novgorod

Saint Petersburg

Volgograd

Bloemfontein

Cape Town

Johannesburg

Bangkok

Chiang Mai

Khon Kaen

Kampala

London

Manchester

All Listed Sponsors
lead

Tibotec Pharmaceuticals, Ireland

INDUSTRY

NCT00110305 - A Study of TMC278 in Human Immunodeficiency Virus Type 1 Infected Patients, Who Are Not Treated With Antiretroviral Medicines | Biotech Hunter | Biotech Hunter