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

Completed · Phase 2

Conditions studied: HIV-1, HIV Infections

In brief

The purpose of this study is to evaluate the pharmacokinetics (the study of the way a drug enters and leaves the blood and tissues over time), safety, tolerability and antiviral activity to support dose recommendations of TMC114 with ritonavir and other antiretroviral agents in treatment-experienced, human immunodeficiency virus (HIV)-1 infected children and adolescents.

Key facts

Study ID

NCT00355524

Run by

Tibotec Pharmaceuticals, Ireland

People needed

80

Starts

2006-06-01

Expected to finish

2011-03-01

Last updated by the study team

2013-07-08

Who can join

Age: 6 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants with documented human immunodeficiency virus (HIV)-1 infection failing their current antiretroviral therapy
• Body weight for Part 1: greater than or equal to 20 Kilogram (kg) but less than 50 kg and body weight for Part 2: greater than or equal to 50 kg and from greater than or equal to 20 but less than 50 kg after pediatric dose selection
• Able to swallow the TMC114 tablet formulations, the ritonavir capsule formulation, and to tolerate the ritonavir liquid formulation
• Stable cluster of differentiation 4 (CD4+) percentage; that is no more than 5 percent decrease in CD4+ percentage between the Screening visit and the last available CD4+ measurement
• Female participants who are sexually active and able to become pregnant must use a safe and effective birth control method

You may not qualify if…

• For Part 1: Use of the non-nucleoside analogue reverse transcriptase inhibitor (NNRTI) efavirenz as part of the current regimen was not allowed and for Part 2: Use of efavirenz as part of the current regimen was allowed and use of any antiretroviral and non-antiretroviral investigational agents within 30 days prior to screening
• Presence of any currently active acquired immune deficiency syndrome (AIDS) defining illness (Category C conditions according to the Centers for Disease Control [CDC] Classification System for HIV Infection 1993 or according to the 1994 revised CDC Classification System for HIV infection in children less than 13 years of age)
• Pregnant or breastfeeding female participants
• Previous allergy or hypersensitivity to any excipients of the investigational medication (TMC114) or ritonavir
• Any Grade 3 or 4 toxicity as defined by the Division of Acquired Immunodeficiency Syndrome (DAIDS) grading scale

Where it is running

• Study site — Los Angeles, California, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Chicago, Illinois, United States
• Study site — Boston, Massachusetts, United States
• Study site — Worcester, Massachusetts, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Memphis, Tennessee, United States
• Study site — Buenos Aires, Argentina
• Study site — Belo Horizonte, Brazil
• Study site — Nova Iguaçu, Brazil
• Study site — Ribeirão Preto, Brazil
• Study site — Rio de Janeiro, Brazil
• Study site — Toronto, Ontario, Canada
• Study site — Montreal, Quebec, Canada
• Study site — Paris, France
• Study site — Bucharest, Romania
• Study site — Constanța, Romania
• Study site — Cape Town Cape, South Africa
• Study site — Durban, South Africa
• Study site — Johannesburg Gauteng, South Africa
• Study site — Esplugues de Llobregat, Spain
• Study site — Madrid, Spain

Full record on ClinicalTrials.gov

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