HIV-1 Infection MedDRA version: 20.1 Level: LLT Classification code 10068341 Term: HIV-1 infection System Organ Class: 100000004862
Conditions
Interventions
Trade Name: Edurant®
Product Name: Rilpivirine
Product Code: TMC278
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Rilpivirine Hydrochloride
CAS Number: 700361-47-3
Current Sponsor code:
Sponsors
Janssen Sciences Ireland UC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Each potential participant must satisfy all of the following criteria to be enrolled in the study: 1. Aged =2 to =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Any potential participant who meets any of the following criteria will be excluded from participating in the study: 1. Have previously documented HIV-2 infection. 2. Have known or suspected acute (primary) HIV-1 infection. 3. Taken any disallowed concomitant therapies within 4 weeks before the planned first dose of study intervention. 4. A positive HLA-B*5701 test at screening (when the investigator considers ABC in the background regimen). In case of a positive test, ABC cannot be administered, but instead, the investigator can select another ARV in the background regimen. HLA-B*5701 testing is not required for participants with prior documented negative results. 5. Any current or history of adrenal disorder. 6. Any active clinically significant diseases (eg, pancreatitis, cardiac dysfunction, active and significant psychiatric disorders, clinical suspicion of adrenal insufficiency, and hepatic impairment) or findings at screening or medical history that, in the investigator’s opinion, would compromise the outcome of the study. 7. A history of virologic failure to ARVs with or without availability of an HIV-1 genotype result at the time of failure. 8. Documented genotypic evidence of resistance to RPV or to the selected background ARVs from historical data available in the source documents (ie,at least 1NNRTI RAM from the following list compiled on the basis of the list of the International Antiviral Society United States of America [IAS-USA] NNRTI RAMs and other relevant publications). 9. A known clinically significant allergy, hypersensitivity, or intolerance to RPV or its excipients or to the selected background ARVs. 10. Criterion modified per Amendment 1 10.1 Received an investigational intervention (including investigational vaccines) containing an active substance or used an invasive investigational medical device within 90 days before the planned first dose of study intervention.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objectives are: • To evaluate the steady-state pharmacokinetics (PK) of rilpivirine and determine the appropriate dose of rilpivirine in combination with other antiretrovirals (ARVs) in participants aged =2 to <12 years with a body weight of <25 kg. • To evaluate the safety and tolerability of rilpivirine in combination with other ARVs in participants aged =2 to <12 years over a 24-week treatment period.;Secondary Objective: The secondary objectives are: • To evaluate the safety and tolerability of rilpivirine in combination with other ARVs over a 48-week treatment period. • To evaluate the efficacy of rilpivirine in combination with other ARVs over a 24- and 48-week treatment period. • To evaluate population PK and PK/pharmacodynamic (PD) relationships for safety and efficacy of rilpivirine in combination with other ARVs. • To assess resistance in case of loss of virologic response to rilpivirine in combination with other ARVs. • To evaluate treatment adherence to rilpivirine in combination with other ARVs over a 24 and 48 week treatment period.;Primary end point(s): 1. Area under the plasma concentration-time curve from time of administration up to 24 hours post dose of rilpivirine, as derived from the intensive PK assessments. 2. Incidence of grade 3/4 AEs, SAEs, HIV-related events (including acquired immune deficiency syndrome [AIDS]-defining illnesses and Stage-3-defining Opportunistic Illnesses in HIV Infection), and AEs leading to discontinuation of study intervention through 24 weeks of study treatment.;Timepoint(s) of evaluation of this end point: 1. From time of administration up to 24 hours postdose of rilpivirine 2. Until 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Incidence and severity of AEs/HIV-related events and their relatedness to RPV through 24 and 48 weeks of study treatment. 2. Change from baseline over time and shift in toxicity grades/abnormalities versus reference for clinical laboratory parameters, ECG parameters, vital signs, and physical examination through 24 and 48 weeks of study treatment. 3. Proportion of participants with HIV-1 RNA <50 and =50 copies/mL using the Food and Drug Administration (FDA) Snapshot approach through 24 and 48 weeks of study treatment. 4. Immunologic changes, measured by CD4+ cell count (absolute and percentage relative to total lymphocytes), through 24 and 48 weeks of study treatment. 5. Pharmacokinetic parameters of RPV (other than area under the plasma concentration-time curve [AUC]), as derived from the intensive PK assessments. 6. Pharmacokinetic parameters of rilpivirine, as derived by population PK modeling, through 24 and 48 weeks of study treatment. 7. Viral genotype at the time of virologic failure through 24 and 48 weeks of study treatment. 8. Treatment adherence, as assessed by the Pediatric European Network for the Treatment of AIDS (PENTA) adherence questionnaire and by study intervention accountability, through 24 and 48 weeks of study treatment.;Timepoint(s) of evaluation of this end point: 1 to 4, 6 to 8: Through 24 and 48 weeks of study treatment | — |
Countries
Italy, Portugal, Romania, South Africa, Spain, Thailand, Uganda
Contacts
Public ContactGlobal Clinical Operations Spain
JANSSEN CILAG, S.A.
Outcome results
None listed