Status:
COMPLETED
A Phase 2 Study to Evaluate Pharmacokinetics, Safety and Efficacy of TMC114/Ritonavir (Rtv) in Human Immunodeficiency Virus (HIV)-1 Infected Children and Adolescents
Lead Sponsor:
Tibotec Pharmaceuticals, Ireland
Conditions:
HIV-1
HIV Infections
Eligibility:
All Genders
6-17 years
Phase:
PHASE2
Brief Summary
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 do...
Detailed Description
This is an open-label (all people know the identity of the intervention) and randomized (study drug assigned by chance) study to evaluate pharmacokinetics, safety, tolerability, efficacy, antiviral ac...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00355524
Start Date
June 1 2006
End Date
March 1 2011
Last Update
July 8 2013
Active Locations (22)
Enter a location and click search to find clinical trials sorted by distance.
1
Los Angeles, California, United States
2
Washington D.C., District of Columbia, United States
3
Chicago, Illinois, United States
4
Boston, Massachusetts, United States