Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Etravirine · 3 trials · 5 indications
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Proportion of patients with at least 1 treatment-emergent Grade 1-4 Central Nervous System or psychiatric Adverse Event, observed between Baseline through Week 12 and judged by investigator to be at least possibly related to the study drug in ETR group versus EFV group. All Adverse Events were graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events ("DAIDS AE grading table"). Grade 1-4 covers all severities.
the effect of ETR or DRV/rtv on the pharmacokinetics of artemether, lumefantrine and the artemether metabolite dihydroartemisinin (DHA) after single and multiple dose(s) in healthy subjects. plasma concentrations: minimum (Cmin) and maximum (Cmax): artemether and DHA (Day 11 of Treatment B versus Day 4 of Treatment A, Days 11-14 of Treatment B versus Days 4-7 of Treatment A ), lumefantrine (Days 11-22 of Treatment B versus Days 4-15 of Treatment A ); Cmax artemether and DHA (Day 8-9 of Treatment B versus Day 1-2 of Treatment A )
effect of ETR or DRV/rtv on the AUC from time of administration (0 hours) to 8 hours after dosing (AUC8h): artemether and DHA (Day 8-9 of Treatment B versus Day 1-2 of Treatment A); AUC from 0 to 12 hours (AUC 12h) artemether and DHA (Day 11 of Treatment B versus Day 4 of Treatment A ); AUC from 0 to 264 hours (AUC264h) lumefantrine (Days 11-22 of Treatment B versus Days 4-15 of Treatment A ; AUC from 0 to the last time point with a measurable concentration post dosing (AUClast) artemether and DHA (Days 11-14 of Treatment B versus Days 4-7 of Treatment A )
Cmin and Cmax for ETR, DRV and ritonavir (Day 11 of Treatment B versus Day 8 of Treatment B )
AUC from time of administration to 12 hours after dosing (AUC12h) for ETR, DRV and ritonavir (Day 11 of Treatment B versus Day 8 of Treatment B)
| Arm | Type | Description |
|---|---|---|
| Etravirine | EXPERIMENTAL | Etravirine Dosed by weight up to a maximum dose of 200 milligram (mg) bid until switched to an etravirine (ETR)-based treatment regimens (i.e. commercially available and reimbursed, or accessible through another source) or local standard of care, as appropriate. |
| efavirenz | ACTIVE_COMPARATOR | efavirenz (EFV) 600mg once daily (1x600mg tablet) + 2 NRTIs + 4 ETR placebo tablets for 48 weeks |
| ETR, artemether/lumefantrine | EXPERIMENTAL | treatment with artemether/lumefantrine 80/480 mg during 3 days (treatment A) and treatment during 22 days with etravirine for 22 days and artemether/lumefantrine 80/480 mg from day 8 to day 11 (treatment B) with a washout of at least 4 weeks between the 2 treatment periods |
| DRV/rtv, artemether/lumefantrine | EXPERIMENTAL | treatment with artemether/lumefantrine 80/480 mg during 3 days (treatment A) and treatment during 22 days with darunavir/ritonavir and artemether/lumefantrine 80/480 mg from day 8 to day 11 (treatment B) with a washout of at least 4 weeks between the 2 treatment periods |
| Name | Type | Description |
|---|---|---|
| Etravirine | DRUG | Participants will be dosed with etravirine by weight up to a maximum dose of 200 mg bid until switched to an etravirine-based treatment regimens (i.e. commercially available and reimbursed, or accessible through another source) or local standard of care, as appropriate. |
| etravirine (ETR, TMC125) | DRUG | 400mg once daily (4x100mg tablet) + 2 NRTI + 1 EFV placebo tablet for 48 weeks |
| efavirenz (EFV) | DRUG | 600mg once daily (1x600mg tablet) + 2 NRTIs + 4 ETR placebo tablets for 48 weeks |
| Darunavir/ritonavir | DRUG | DRV/rtv 600/100 mg b.i.d. from Day 1 to Day 21 with a single dose of DRV/rtv in the morning on Day 22 |
| artemether/lumefantrine | DRUG | 3 days of treatment with artemether/lumefantrine 80/480 mg (6 doses of 4 tablets \[20/120 mg\] at 0, 8, 24, 36, 48, and 60 hours) |
Inclusion Criteria: * Participants who meet all of the following criteria are eligible for this trial: Documented HIV-1 infection * Male or female participants, aged 2 years and older * Successfully completed a clinical (parent) pediatric trial with ETR sponsored by or in collaboration with Janssen...
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Etravirine is an investigational small molecule being studied for the treatment of HIV, HIV Infections, and HIV Infection. It is being developed by Johnson & Johnson (JNJ) and is currently in Phase 1 clinical development for these indications.
Etravirine is a small molecule being developed for HIV treatment. While its specific molecular target is not disclosed in the available information, it is being studied in combination with other antiretroviral agents in clinical trials for HIV-1 infected patients.
Etravirine is being developed by Johnson & Johnson, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol JNJ. The company is conducting clinical trials to evaluate the drug's safety and efficacy in treating HIV infections.
Etravirine is currently in Phase 1 clinical development. While it has completed Phase 2 and Phase 3 trials, the most advanced ongoing development stage is Phase 1, indicating it remains investigational and is not yet approved by regulatory authorities.
Etravirine has been studied in clinical trials including NCT00903682, a Phase 2 trial comparing its tolerability to efavirenz in treatment-naive HIV-1 patients, and NCT00980538, a Phase 3 continued access study in treatment-experienced participants. These trials are completed.
Etravirine is also known by the code name TMC125, as referenced in clinical trial NCT00980538. This alternative name is used in research contexts to identify the same investigational drug being developed for HIV treatment.