Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Sustiva®, BMS-561525
Efavirenz · 3 trials · 2 indications
QTcF = QT corrected for Fridericia's formula
Cmax and Cmin were derived from plasma concentrations versus time using a validated liquid chromatography tandem mass spectrometry method (LC-MS/MS). The lower limit of quantification (LLOQ) for EFV was 10.0 nanograms per milliliter (ng/mL) and the upper limit of quantification (ULOQ) was 8,000 ng/mL. Cmax and Cmin were recorded directly from experimental observations. Blood samples were collected before study drug administration and at 0.5, 1, 3, 5, 8, and 24 hours after study drug administration from an indwelling catheter or by direct venipuncture and the pharmacokinetic parameters were summarized using geometric means. Cmax and Cmin were measured in ng/mL.
Plasma concentrations were obtained using a validated liquid chromatography tandem mass spectrometry method (LC-MS/MS). The lower limit of quantification (LLOQ) for EFV was 10.0 nanograms per milliliter (ng/mL) and the upper limit of quantification (ULOQ) was 8,000 ng/mL. AUC(TAU) was calculated by log- and linear trapezoidal summations. If a concentration was \< LLOQ at time TAU, the value of the concentration at time TAU was estimated using the quotient of the last quantifiable concentration and λ. Blood samples were collected before study drug administration and at 0.5, 1, 3, 5, 8, and 24 hours after study drug administration from an indwelling catheter or by direct venipuncture and the pharmacokinetic parameters summarized using geometric means. AUC(TAU) was measured in micromolars\*time (µM•h).
Plasma concentrations of EFV were obtained using a validated liquid chromatography tandem mass spectrometry method (LC-MS/MS). The lower limit of quantification (LLOQ) for EFV was 10.0 nanograms per milliliter (ng/mL) and the upper limit of quantification (ULOQ) was 8,000 ng/mL. CLT/F was calculated by dividing the dose of EFV by AUC(TAU) of EFV. Blood samples were collected before study drug administration and at 0.5, 1, 3, 5, 8, and 24 hours after study drug administration from an indwelling catheter or by direct venipuncture and the pharmacokinetic parameters were summarized using geometric means. CLT/F was measured in liters per hour (L/h).
Plasma concentrations of EFV were determined using a validated liquid chromatography tandem mass spectrometry method (LC-MS/MS). The lower limit of quantification (LLOQ) for EFV was 10.0 nanograms per milliliter (ng/mL) and the upper limit of quantification (ULOQ) was 8,000 ng/mL. CLT/F/kg was calculated by dividing CLT/F by body weight in kilograms (kg). Blood samples were collected before study drug administration and at 0.5, 1, 3, 5, 8, and 24 hours after study drug administration from an indwelling catheter or by direct venipuncture and the pharmacokinetic parameters were summarized using geometric means. CLT/F/kg was measured in liters per hour per kilogram (L/h/kg).
| Arm | Type | Description |
|---|---|---|
| Moxifloxacin, Placebo, Efavirenz | EXPERIMENTAL | Moxifloxacin, Placebo, Efavirenz single dose as specified |
| EFV+ddI+FTC in patients >= 3 months to < 6 months | EXPERIMENTAL | EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle, or oral solution (30 mg/mL. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg. |
| EFV+ddI+FTC in patients >=6 months to < 2 years | EXPERIMENTAL | EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle, or oral solution (30 mg/mL. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg. |
| EFV+ddI+FTC in patients >= 2 years to < 3 years | EXPERIMENTAL | EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle, or oral solution (30 mg/mL. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg. |
| EFV+ddI+FTC in patients >= 3 years to <= 6 years | EXPERIMENTAL | EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle, or oral solution (30 mg/mL. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg. |
| Name | Type | Description |
|---|---|---|
| Efavirenz | DRUG | - |
| Lamivudine | DRUG | - |
| Stavudine | DRUG | - |
| Moxifloxacin | DRUG | - |
| Placebo | DRUG | - |
| Efavirenz (EFV) + Didanosine (ddI) + Emtricitabine (FTC) | DRUG | Oral Solution, Capsules or Tablets, Oral, once daily Efavirenz (EFV) per weight-based dosing nomogram (max 720 mg) Didanosine (ddI) 240 mg/m2 (max 400 mg) Emtricitabine (FTC) 6 mg/kg (max 200 mg) Where EFV oral solution is commercially available: 48 weeks or until 3rd birthday (whichever is longer); Where EFV oral solution NOT commercially available: until 7th birthday or until able to swallow EFV capsules (whichever occurs first) |
Inclusion Criteria Patients may be eligible for this study if they: * Are at least 18 years old. Patients living in USA, Puerto Rico, Australia, Brazil, Singapore, and Thailand can be at least 12 years old (need consent of parent or guardian if under 18). * Have a viral load of at least 2,000 copi...
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Efavirenz is used to treat HIV infections and HIV/AIDS. It is a small molecule antiretroviral studied in combination regimens for adults and children, including pediatric patients as young as 3 months. Its clinical program includes Phase 3 and Phase 1 trials in HIV-infected and healthy subjects.
Efavirenz is developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. The company has sponsored clinical studies of the drug in HIV-infected adults and children, including a Phase 3 trial and two Phase 1 trials.
Efavirenz has been studied in Phase 3 and Phase 1 clinical trials. The Phase 3 study, NCT00005918, enrolled 730 HIV-infected patients, and two Phase 1 studies enrolled 58 and 56 participants. All three listed trials are completed, and no active trials are ongoing.
Efavirenz has been evaluated in three completed trials: NCT00005918, a Phase 3 study of two forms of stavudine in HIV-infected patients; NCT00364793, a Phase 1 study of safety, tolerability, and pharmacokinetics in HIV-infected children; and NCT02164812, a Phase 1 study of its effect on the ECG QTcF interval in healthy subjects.