Phase 2
Completed N=54
A Study to Evaluate the Pharmacokinetics, Safety, Tolerability, and Antiviral Activity of Rilpivirine (TMC278) in Human Immunodeficiency Virus Infected Adolescents and Children Aged Greater Than or Equal to 6 Years
Source: ClinicalTrials.gov NCT00799864 ↗Enrolled (actual)
54
Serious AEs
11.1%
Results posted
Jun 2024
Primary outcomePrimary: Cohorts 1 and 2: Pharmacokinetics (PK) of Rilpivirine (TMC278) as Measured by Maximum Observed Plasma Concentration at Steady State (Cmax,ss) — 109; 154; 238 nanograms per milliliter (ng/mL)
Summary
The purpose of this study is to evaluate the pharmacokinetics, safety and antiviral activity of rilpivirine (TMC278) 25 milligram (mg) or adjusted dose once daily in combination with an investigator-selected background regimen containing 2 nucleoside/nucleotide reverse transcriptase inhibitors (N[t]RTIs) (zidovudine [AZT], abacavir [ABC], or tenofovir disoproxil fumarate [TDF] in combination with lamivudine [3TC] or emtricitabine [FTC] in antiretroviral (ARV) treatment-naïve adolescents and children aged greater than or equal to (>=) 6 to less than (<) 18 years.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cohorts 1 and 2: Pharmacokinetics (PK) of Rilpivirine (TMC278) as Measured by Maximum Observed Plasma Concentration at Steady State (Cmax,ss) |
109; 154; 238 | — |
| PRIMARY Cohort 2: Pharmacokinetics (PK) of Rilpivirine (TMC278) as Measured by Maximum Plasma Concentration at Steady State (Cmax,ss) |
138; 184; 81.9; 156 | — |
| PRIMARY Cohorts 1 and 2: Pharmacokinetics of Rilpivirine as Measured by Area Under the Plasma Concentration Curve at Steady State (AUC24, ss) |
1872; 2610; 3339 | — |
| PRIMARY Cohort 2: Pharmacokinetics of Rilpivirine as Measured by Area Under the Plasma Concentration Curve at Steady State (AUC24, ss) |
1933; 2877; 1710; 2958 | — |
| SECONDARY Cohorts 1 and 2: Number of Participants With Adverse Events (AEs) |
35; 8; 5; 2; 2 | — |
| SECONDARY Cohorts 1 and 2: Percentage of Participants With Plasma Human Immunodeficiency Virus -1 (HIV-1) Ribonucleic Acid (RNA) Level Less Than (<) 50 Copies/mL by Time to Loss of Virologic Response (TLOVR) Method |
72.2; 43.8 | — |
| SECONDARY Cohorts 1 and 2: Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL by Food and Drug Administration (FDA) Snapshot Approach |
72.2; 53.1 | — |
| SECONDARY Cohorts 1 and 2: Number of Participants With Post Baseline Genotype Data |
9; 5; 7; 4 | — |
| SECONDARY Cohorts 1 and 2: Percentage of Participants With Treatment Adherence >95% Based on Drug Accountability |
80.6; 77.8; 77.8 | — |
| SECONDARY Cohorts 1 and 2: Change From Baseline in Cluster of Differentiation (CD4+) Cells |
201.2; 215.9; 113.6 | — |
Eligibility Criteria
Inclusion Criteria
- Has documented human immuno deficiency virus (HIV-1) infection
- Patients who meet the following criteria; a) Cohort 1: Patients Aged greater than or equal to (>=) 12 to less than ( = 32 kilogram (kg), b) Cohort 2; Aged >= 6 to = 17 kg
- Must have HIV-1 plasma viral load at screening greater than equal to 500 HIV-1 ribonucleic acid (RNA) copies/mL
- Have not received treatment with a therapeutic HIV vaccine or an HIV drug with the exception of a single dose of nevirapine (NVP) (Cohort 1 and Cohort 2) or up to 6 weeks of zidovudine (AZT) use (Cohort 2 only) prior to screening to prevent mother-to-child transmission (MTCT)
- In the judgment of the investigator, it is appropriate to initiate antiretroviral therapy (ARV) therapy based on a patient's medical condition and taking into account guidelines for the treatment of HIV-1 infection in children of this age group
Exclusion Criteria
- Any previous use of ARVs with the exception of single dose NVP (Cohort 1 and Cohort 2) or up to 6 weeks of AZT (Cohort 2 only) to prevent MTCT
- Plasma viral load at screening greater than 100,000 HIV-1 RNA copies/mL
- Documented genotypic evidence of non-nucleoside reverse transcriptase inhibitor (NNRTI) resistance at screening or from historical data available in the source documents
- Use of disallowed concomitant therapy from 4 weeks prior to the baseline visit
- Patient has any currently active Acquired Immunodeficiency Syndrome (AIDS) defining illness
- Patient has active tuberculosis and/or is being treated for tuberculosis at screening
- Personal history of cardiac disease (including congenital heart disease), or symptomatic arrhythmias, with the exception of sinus arrhythmia; personal history of asymptomatic arrhythmias is excluded if the asymptomatic arrhythmia is clinically significant in the opinion of the investigator
Data sourced from ClinicalTrials.gov (NCT00799864). 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.