Phase 2
Completed N=101
TMC125-TiDP35-C213: Safety and Antiviral Activity of Etravirine (TMC125) in Treatment-Experienced, HIV Infected Children and Adolescents
Source: ClinicalTrials.gov NCT00665847 ↗Enrolled (actual)
101
Serious AEs
5.0%
Results posted
Dec 2012
Primary outcomePrimary: The Number of Patients With Treatment-emergent Adverse Events (TEAEs) — 89; 0; 5; 14 Patients
Summary
The purpose of this study is to determine the safety and antiviral activity of etravirine in treatment-experienced human immunodeficiency virus (HIV) infected children and adolescents.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Number of Patients With Treatment-emergent Adverse Events (TEAEs) |
89; 0; 5; 14; 8; 8 | — |
| PRIMARY The Percentage of Patients With Treatment-emergent Adverse Events (TEAEs) |
88.1; 0; 5.0; 13.9; 7.9; 7.9 | — |
| SECONDARY Population Pharmacokinetic (PK) Estimates of Etravirine/TMC125 (ETR): Area Under the Plasma Concentration-time Curve Over 12 Hours at Steady-state (AUC12h) |
5216 | — |
| SECONDARY Population Pharmacokinetic (PK) Estimates of Etravirine/TMC125 (ETR): Trough Plasma Concentration (C0h) |
346 | — |
| SECONDARY Population Pharmacokinetic (PK) Estimates of Etravirine/TMC125 (ETR): Maximum Plasma Concentration (Cmax) |
589 | — |
| SECONDARY Percentage of Patients With Virologic Response at Week 24 |
52.5 | — |
| SECONDARY Change From Baseline in Human Immunodeficiency Virus - Type 1 (HIV-1) Ribonucleic Acid (RNA) in Plasma Over Time |
-1.53 | — |
| SECONDARY The Change From Baseline in CD4 Cell Counts Over Time |
156 | — |
| SECONDARY The Emergence of Non-nucleoside Reverse Transcriptase Inhibitor Resistance-associated Mutations (NNRTI RAMs) in Patients Classified as Virologic Failures |
3; 3; 3; 8 | — |
Eligibility Criteria
Inclusion Criteria
- HIV-1 infected
- Body weight according to age within the 10-90th percentile of CDC growth chart
- On steady antiretroviral therapy regimen for at least 8 weeks at screening and willing to remain on that regimen until baseline
- HIV viral load of 1, 000 copies/ml or greater at study entry
- Parent or legal guardian willing to provide informed consent, if necessary
Exclusion Criteria
- The Key Exclusion Criteria are: Evidence of resistance to etravirinel Any grade 3 or 4 toxicity (More information available in the protocol)
- Use of disallowed concomitant therapy (specified in the protocol)
- Currently active AIDS defining illness (category C)
- Active hepatitis A, B or C virus infection
- Any clinically significant diseases or findings that, in the opinion of the investigator, would interfere with the study
- Receipt of any ARV or non-ARV investigational medication or investigational vaccine within 30 days prior to screening
- History of clinically significant allergy or hypersensitivity to any of the excipients of the investigational medication (TMC125)
Data sourced from ClinicalTrials.gov (NCT00665847). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.