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Label indication Etravirine, in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-experienced adult patients and pediatric patients 2 years of age and older [see Microbiology (12.4) and Clinical Studies (14) ] . FDA label
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...
Top 19 of 30 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Pfizer Inc. | PFE | 7 | PHASE3 | VLA15, Prevenar 20, 13vPnC, ATM-AVI, PG4 |
| Sanofi SA Sponsored ADR | SNY | 1 | PHASE3 | PCV21 |
| GSK plc Sponsored ADR | GSK | 4 | PHASE2 | Penmenvy, iNTS-TCV, Strep A vaccine, Pan-Salmonella vaccine |
| Grifols, S.A. Sponsored ADR Class B | GRFS | 1 | PHASE3 | Xembify |
| CorMedix Inc. | CRMD | 1 | PHASE3 | DefenCath |
| Sinovac Biotech Ltd. | SVA | 4 | PHASE3 | Sinovac PCV24, Group ACYW135X Meningococcal Conjugate Vaccine, Group ACYW135 Meningococcal Conjugate Vaccine |
| Novartis AG Sponsored ADR | NVS | 2 | PHASE2 | EDI048 |
| Innoviva, Inc. | INVA | 3 | PHASE2 | Eravacycline, Sulbactam-durlobactam |
| BiomX Inc. | PHGE | 1 | PHASE2 | BX004 |
| Hoffmann-La Roche | RHHBY | 1 | PHASE3 | Baloxavir Marboxil |
| Merck & Co., Inc. | MRK | 2 | PHASE1 | V118C |
| AstraZeneca PLC | AZN | 1 | PHASE1 | AZD7760 |
| BioNTech SE Sponsored ADR | BNTX | 1 | PHASE1 | BNT163 |
| 60 Degrees Pharmaceuticals, Inc. | SXTP | 1 | PHASE2 | Tafenoquine |
| Tarsus Pharmaceuticals, Inc. | TARS | 1 | PHASE2 | TP-05 |
| Moderna, Inc. | MRNA | 1 | PHASE2 | mRNA-1982 |
| AN2 Therapeutics, Inc. | ANTX | 1 | PHASE2 | Epetraborole |
| Emergent BioSolutions Inc. | EBS | 4 | - | AIGIV/kg |
| Phathom Pharmaceuticals, Inc. | PHAT | 1 | - | Vonoprazan |
Etravirine is used to treat HIV and HIV infection. It is a small molecule antiviral studied in HIV-1 infected patients, including treatment-experienced and treatment-naive adults and children. Trials have evaluated it both as part of combination antiretroviral regimens and in drug interaction studies.
Etravirine is developed by Johnson & Johnson, which trades under the ticker JNJ. The company has sponsored clinical studies of the drug in HIV, including a continued access program for treatment-experienced HIV-1 infected participants and a tolerability comparison against efavirenz.
Etravirine has been studied across Phase 1, Phase 2, and Phase 3 clinical trials, all of which are completed. No trials are currently active. The program includes a Phase 3 continued access study and a Phase 2 tolerability trial.
Etravirine has been evaluated in completed trials including NCT01876966, a Phase 1 interaction study with darunavir/ritonavir and artemether/lumefantrine in 33 healthy volunteers; NCT00980538, a Phase 3 continued access study in 180 HIV-1 infected participants; and NCT00903682, a Phase 2 tolerability trial in 157 treatment-naive patients.
Yes. Etravirine is also known as TMC125 and is abbreviated ETR. The 200 mg dose is referred to as etravirine (ETR) 200 mg. These names refer to the same small molecule HIV treatment developed by Johnson & Johnson.
Across the reported etravirine trials, total enrollment is 337 participants. The studies were randomized and controlled, with enrollment ranging from 33 healthy volunteers in a Phase 1 interaction study to 180 participants in a Phase 3 continued access program.