HIV infection MedDRA version: 9.1 Level: LLT Classification code 10020161 Term: HIV infection
Conditions
Interventions
Product Name: TMC278 (as the hydrochloric acid salt), R314585
Product Code: GFI-314585-CA-026, F006
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: rilpivirine hydrochloride
CAS Number: 7
Sponsors
Tibotec Pharmaceuticals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female subjects's, aged 18 years or older; 2. S (Subject) with documented HIV-1 infection; 3. S has signed the ICF voluntarily; 4. S can comply with the protocol requirements; 5. S has never been treated with a therapeutic HIV vaccine or an ARV drug prior to screening; 6. S’s HIV-1 plasma viral load at screening is = 5,000 HIV-1 RNA copies/mL 7. In the judgment of the inv., it is appropriate to initiate ARV therapy based on the s’s medical condition and taking into account guidelines for the treatment of HIV-1 infection; 8. Demonstrated sensitivity to ABC and 3TC, AZT and 3TC, and/or TDF and FTC based on results from the screening virco®TYPE HIV-1 using the lower clinical cut-off or the biological cut-off on the screening virco®TYPE HIV-1 result) and available historical data; 9. S is HLA-B*5701 negative;HLA-B*5701 retesting is not required for subjects with prior documented HLA-B*5701 negative results; 10. S agrees not to start ART before the baseline visit; 11. S’s general medical condition, in the investigator’s opinion, does not interfere with the assessments and the completion of the trial. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Any previous treatment with a therapeutic HIV vaccine or use of ARVs, incl. use of NVP for the prevention of vertical HIV transmission 2. Having documented genotypic evidence of NNRTI resistance at screening or from historical data avail. in the source docs, i.e. at least 1 of the NNRTI RAMs from follow. list: A098G L100I K101E K101P K101Q K103H K103N K103S K103T V106A V106M V108I E138A E138G E138K E138Q E138R V179D V179E Y181C Y181I Y181V Y188C Y188H Y188L G190A G190C G190E G190Q G190S G190T P225H F227C M230I M230L P236L K238N K238T Y318F 3. Previously documented HIV-2 infection 4. Use of disallowed concomitant therapy from 4 weeks prior to baseline visit 5. Any condition which, in the opinion of the inv., could compromise the S’s safety or adherence to CTP 6. Life expectancy 450 ms in the screening ECG - Pathological Q-waves - Evidence of ventricular pre-excitation - Electrocardiographic evidence of complete or incomplete left bundle branch block or right bundle branch block - Evidence of 2nd or 3rd degree heart block - Intraventricular conduction delay with QRS duration > 120 ms - Bradycardia as defined by sinus rate < 50 bpm - Personal or family history of long QT syndrome - Personal history of cardiac disease, symptomatic or asymptomatic arrhythmias, with the exception of sinus arrhythmia - Syncopal episodes - Risk factors for Torsades de Pointes (eg. heart failure, hypokalemia, hypomagnesemia) 12. Receipt of any investigational drug or investigational vaccine within 90 days prior to first trial drug administration 13. S enrolled in other clinical trials that incl. any blood sampling with a volume higher than 50 mL taken over the course of 6 months, specimen collection, or other interventional procedure. Concurrent participation in non-interventional observational trials is allowed as long as there is no impact on objectives of this trial. Data collected in this
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): proportion of subjects with confirmed and sustained plasma viral load <50 HIV-1 RNA copies/mL (TLOVR algorithm) at Week 48;Main Objective: The primary objective of the trial is to demonstrate non-inferiority of treatment with TMC278 when administered as 25 mg q.d. compared to the control group (EFV) in regard to the proportion of virologic responders (plasma viral load < 50 HIV-1 RNA copies/mL, according to TLOVR algorithm) at 48 weeks in ARV-naïve HIV-infected subjects, with a maximum allowable difference of 12%.;Secondary Objective: -demonstrate non-inferiority of TMC278 compared to control (EFV) with a maximum allowable difference of 10% at 48 weeks for the primary efficacy endpoint. -evaluate superiority in efficacy of TMC278 compared to control, in case non-inferiority is established. -evaluate and compare safety and tolerability of TMC278 when administered as 25 mg q.d. vs control over 48 and 96 weeks -evaluate and compare antiviral activity of TMC278 when administered as 25 mg q.d. vs control over 48 and 96 weeks -evaluate and compare immunologic changes in TMC278 group versus those in control group over 48 and 96 weeks -assess evolution of viral genotype and phenotype over 48 and 96 weeks -evaluate population pharmacokinetics and PK/PD relationships for efficacy and safety of TMC278. -assess preference-based health states and medical resource utilization for use in future economic evaluations -assess treatment adherence as measured by Modified Medication Adherence Self-Report Inventory | — |
Countries
Belgium, France, Germany, Italy, Portugal, United Kingdom
Outcome results
None listed