A Study to Compare Effectiveness and Safety of Darunavir/Ritonavir (DRV/Rtv) 800mg/100mg Once Daily Versus DRV/Rtv 600mg/100mg Twice Daily in Early Treatment-Experienced HIV-1 Infected Patients (ODIN)

PHASE3CompletedINTERVENTIONAL
Enrollment

590

Participants

Timeline

Start Date

October 31, 2007

Primary Completion Date

August 31, 2009

Study Completion Date

October 31, 2011

Conditions
Human Immunodeficiency Virus - Type 1
Interventions
DRUG

Darunavir (DRV)

DRV/rtv 800/100 mg once daily group: 2 tablets of 400 mg of DRV administered orally once daily. DRV/rtv 600/100 mg twice daily group: 1 tablet of 600 mg DRV administered orally twice daily.

DRUG

Ritonavir (rtv)

DRV/rtv 800/100 mg once daily group: One capsule of 100 mg of ritonavir administered orally once daily. DRV/rtv 600/100 mg twice daily group: One capsule of 100 mg of ritonavir administered orally twice daily.

Trial Locations (85)

Unknown

Phoenix

Little Rock

Beverly Hills

Oakland

Palm Springs

Fort Lauderdale

Fort Laudersale

Miami

Miami Beach

Orlando

Safety Harbor

West Palm Beach

Atlanta

Macon

Savannah

Chicago

Springfield

Berkley

Newark

Albany

New York

Rochester

The Bronx

Huntersville

Winston-Salem

Akron

Charleston

Dallas

Harlingen

Houston

Buenos Aires

Córdoba

Guernica

Neuquén

Rosario

Darlinghurst

Surry Hills

Vienna

Curitiba

Distrito Barao Geraldo-Campina

Pinheiros

Recife

Rio de Janeiro

Salvador

São Paulo

Providencia

Santiago

Lyon

Nice

Orléans

Paris

Vandœuvre-lès-Nancy

Berlin

Cologne

München

Guatemala City

Budapest

Ipoh

Kuala Lumpur

Pulau Pinang

Sungai Buloh

Panama City

San Juan

Bucharest

Constanța

Iași

Timișoara

Cape Town

Cyrildene Johannesburg Gauteng

Dundee

Durban

Houghton, Johannesburg

Johannesburg

Pretoria

Westdene Johannesburg Gauteng

Barcelona

Madrid

Kaohsiung County

Taichung

Taipei

Bangkok

Chiang Mai

Khon Kaen

Nonthaburi

London

All Listed Sponsors
lead

Tibotec Pharmaceuticals, Ireland

INDUSTRY

NCT00524368 - A Study to Compare Effectiveness and Safety of Darunavir/Ritonavir (DRV/Rtv) 800mg/100mg Once Daily Versus DRV/Rtv 600mg/100mg Twice Daily in Early Treatment-Experienced HIV-1 Infected Patients (ODIN) | Biotech Hunter | Biotech Hunter