HIV-1 MedDRA version: 8.1 Level: LLT Classification code 10020192 Term: HIV-1
Conditions
Interventions
Product Name: TMC125
Product Code: TMC125 (formulation - F060)
Pharmaceutical Form: Tablet
CAS Number: 269055-15-4
Current Sponsor code: TMC125
Other descriptive name: R165335, Lab code 094268
Concent
Sponsors
Tibotec Pharmaceuticals Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Boys and girls = 6 and = 17 years old. 2. Subjects with documented HIV-1 infection. 3. Subjects weighing = 20 kg and with weight =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Use of disallowed concomitant therapy 2. History or current use of alcohol (more than 2 units per day), barbiturates, amphetamines, recreational or narcotic drugs, which in the investigator’s opinion would compromise the subject’s safety and/or compliance with the trial procedures. 3. Life expectancy of less than 6 months according to the judgment of the investigator. 4. Presence of any currently active AIDS defining illness (Catergory C conditions according to the 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 Note: An AIDS defining illness not clinically stabilized for at least 30 days will be considered as currently active. Note: Primary and secondary prophylaxis for an AIDS defining illness is allowed in cases where the medication administered is not part of the disallowed medications 5. Any active clinically significant disease (e.g. TB, malignancies, cardiac dysfunction, pancreatitis, acute bacterial or viral infections) or findings during screening of medical history or physical examination that, in the investigator’s opinion, would compromise the subject’s safety or outcome of the trial. 6. Subjects with history or at risk of bleeding disorders. 7. Acute and/or chronic viral hepatitis including but not limited to A, B, or C (confirmed by hepatitis A antibody IgM, hepatitis B surface antigen, or hepatitis C virus antibody, respectively) at screening. 8. Receipt of an investigational drug within 30 days prior to the trial drug administration. 9. Previously demonstrated clinically significant allergy or hypersensitivity to TMC125 or any of the excipients of the investigational medication administered in this trial. 10. Any history of significant ARV drug rash requiring permanent drug discontinuation or other clinically significant drug allergy, drug rash, eruptions or urticaria. 11. Pregnancy or breastfeeding. 12. Any grade 3 or grade 4 toxicity according to the Division of AIDS (DAIDS) grading scale Note: Retesting of abnormal screening values that lead to exclusion will be allowed only once using an unscheduled visit during the screening period (to reassess eligibility). 13. Subjects with clinical or laboratory evidence of significantly decreased hepatic function or decompensation, irrespective of liver enzyme levels (International Normalized Ratio [INR]> 1.5 or albumin 2.5 x ULN). 14. A positive urine drug test at screening. Urine will be tested to check the current use of amphetamines, benzodiazepines, cocaine, cannabinoids, and opioids. 15. Currently significant diarrhea, gastric stasis, or constipation that in the investigator’s opinion could influence drug absorption or bioavailability. 16. Having developed rash, erythema, or urticaria while participating in Stage I of this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - to obtain steady-state pharmacokinetics of TMC125 b.i.d in treatment-experienced HIV-1 infected children; - to obtain dose recommendations of TMC125 per body weight in treatment-experienced HIV-1 infected children = 6 years old and weighing = 20 kg.;Secondary Objective: The secondary objective is to evaluate short-term safety and tolerability of TMC125 b.i.d. in treatment-experienced HIV-1 infected children.;Primary end point(s): - to obtain steady-state pharmacokinetics of TMC125 b.i.d in treatment-experienced HIV-1 infected children; - to obtain dose recommendations of TMC125 per body weight in treatment-experienced HIV-1 infected children = 6 years old and weighing = 20 kg. | — |
Countries
Germany, United Kingdom
Outcome results
None listed