A Phase 2 Study to Evaluate Pharmacokinetics, Safety and Efficacy of TMC114/Ritonavir (Rtv) in Human Immunodeficiency Virus (HIV)-1 Infected Children and Adolescents
HIV-1, HIV Infections
About this trial
This is an interventional treatment trial for HIV-1 focused on measuring HIV-1, Darunavir, Ritonavir, TMC114
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Group A with >= 20 kg to < 30 kg body weight
Group A with >= 30 kg to < 40 kg body weight
Group A with >= 40 kg to < 50 kg body weight
Group B with >= 20 kg to < 30 kg body weight
Group B with >= 30 kg to < 40 kg body weight
Group B with >= 40 kg to < 50 kg body weight
Participants with >= 50 kg body weight
300 milligram (mg) of TMC114 tablet with 50 mg (which is equivalent to 0.625 milliliter [mL]) of ritonavir liquid (80 milligram/milliliter [mg/ml]) will be administered orally twice daily.
300 mg of TMC114 tablet with 50 mg (which is equivalent to 0.625 milliliter [mL]) of ritonavir liquid (80 milligram/milliliter [mg/ml]) will be administered orally twice daily.
450 mg of TMC114 tablet with 100 mg of ritonavir capsule will be administered orally twice daily.
375 mg of TMC114 tablet with 50 mg (which is equivalent to 0.625 mL) of ritonavir liquid (80 mg/mL) will be administered orally twice daily.
450 mg of TMC114 tablet with 60 mg (which is equivalent to 0.75 mL) of ritonavir liquid (80 mg/mL) will be administered orally twice daily.
600 mg of TMC114 tablet with 100 mg of ritonavir capsule will be administered orally twice daily.
600 mg of TMC114 tablet with 100 mg of ritonavir capsule will be administered orally twice daily.