A Phase 2 Study to Evaluate Pharmacokinetics, Safety and Efficacy of TMC114/Ritonavir (Rtv) in Human Immunodeficiency Virus (HIV)-1 Infected Children and Adolescents

PHASE2CompletedINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

June 30, 2006

Primary Completion Date

August 31, 2007

Study Completion Date

March 31, 2011

Conditions
HIV-1HIV Infections
Interventions
DRUG

TMC114

TMC114 will be administered as oral tablets (75 milligram \[mg\] or 300 mg) twice daily at a dose ranging from 300-600 mg up to 48 weeks.

DRUG

Ritonavir

Ritonavir will be administered as oral capsules (100 mg) or liquid (80 mg/mL) twice daily at a dose ranging from 50 mg (0.625 mL)-100 mg up to 48 weeks.

Trial Locations (22)

Unknown

Los Angeles

Washington D.C.

Chicago

Boston

Worcester

Philadelphia

Memphis

Buenos Aires

Belo Horizonte

Nova Iguaçu

Ribeirão Preto

Rio de Janeiro

Toronto

Montreal

Paris

Bucharest

Constanța

Cape Town Cape

Durban

Johannesburg Gauteng

Esplugues de Llobregat

Madrid

All Listed Sponsors
lead

Tibotec Pharmaceuticals, Ireland

INDUSTRY

NCT00355524 - A Phase 2 Study to Evaluate Pharmacokinetics, Safety and Efficacy of TMC114/Ritonavir (Rtv) in Human Immunodeficiency Virus (HIV)-1 Infected Children and Adolescents | Biotech Hunter | Biotech Hunter