Approval Probability
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Adjusted LOA
ML Risk
Darunavir/Ritonavir · 1 trial · 1 indication
Number of participants with early discontinuation from randomized HIV PEP for any reason other than confirmation of the negative HIV infection status of the index person in participants receiving HIV PEP for at least 28 days and a maximum of 30 days was assessed. Per protocol (PP) population included all participants in modified intention-to-treat (mITT \[defined as all participants who were assigned to receive randomized HIV PEP and were not discontinued due to confirmation of the negative HIV infection status of the index person\]) excluding participants with: No indication for HIV PEP; Initiation of PEP \>72 hours after injury; Discontinuation of HIV PEP due to confirmation of HIV negative status of index person and if index person bears resistant virus against HIV PEP components prescribed; incorrect HIV PEP; no intake of medication.
| Arm | Type | Description |
|---|---|---|
| DRV/r with 2 NRTIs | EXPERIMENTAL | DRV/r 800/100 mg q.d. with 2 NRTIs: darunavir (800 mg) in combination with low-dose ritonavir (100 mg) administered once a day for at least 28 days and a maximum of 30 days along with 2 nucleoside/nucleotide analogue reverse transcriptase inhibitors (NRTIs). |
| Comparator standard of care HIV PEP | ACTIVE_COMPARATOR | Comparator standard of care HIV PEP (as per German-Austrian Guidelines): Administration of the standard of care HIV PEP (postexposure prophylaxis) consisting of 2 NRTIs plus third partner. |
| Name | Type | Description |
|---|---|---|
| Darunavir/Ritonavir (DRV/r) | DRUG | Darunavir (DRV) type=exact number, unit=mg, number=800, form=tablet, route=oral use. Tablet is taken once a day, for 28 days; Ritonavir (r) type=exact number, unit=mg, number=100, form=tablet, route=oral use. Tablet is taken once a day, for at least 28 days and a maximum of 30 days. |
| Lopinavir in fixed combination with Ritonavir | DRUG | type=exact number, unit=mg, number=400/100, form=tablet, route=oral use. Tablet is taken once or twice a day, for at least 28 days and a maximum of 30 days. |
| Zidovudine | DRUG | type=exact number, unit=mg, number=250, form=tablet, route=oral use. Tablet is taken twice a day, for at least 28 days and a maximum of 30 days. |
| NRTIs | DRUG | The NRTIs (including tenofovir/emtricitabine \[Truvada\], lamivudine/zidovudine \[Combivir\]) will be administered as per the individual Summary of Product Characteristics (SmPCs) at the discretion of either the treating physician or Investigator. |
| Efavirenz | DRUG | type=exact number, unit=mg, number=600, form=tablet, route=oral use. Tablet is taken once a day, for at least 28 days and a maximum of 30 days. |
Inclusion Criteria: * Occupational injury and non-occupational exposure with documented human immunodeficiency virus (HIV) exposure, or potential for HIV exposure * Indication for HIV postexposure prophylaxis (PEP), as determined by the treating physician and/or the investigator * Women must be: po...
Darunavir is used for the treatment of Human Immunodeficiency Virus (HIV), including HIV-1 infections. It is being studied in pregnant women with HIV and HIV infections, as well as in healthy participants for pharmacokinetic and bioequivalence studies. The drug is in clinical development for these infectious disease indications.
Darunavir is developed by Johnson & Johnson, a company traded under the ticker JNJ. The drug is a small molecule being investigated for the treatment of HIV and HIV-1 infections.
Darunavir is in Phase 3 clinical development for HIV and HIV infections. It is an investigational drug and has not been reported as FDA approved. The Phase 3 trial is completed, and the drug is also being studied in earlier phase trials.
Darunavir has completed clinical trials including NCT00855335, a Phase 3 study in HIV-1 infected pregnant women, and NCT01619527, a Phase 1 bioequivalence study in healthy participants. Other completed trials include NCT02984852 and NCT04718805, both Phase 1 studies in healthy adults.
Darunavir is a small molecule that targets HIV protease, an enzyme essential for viral replication. By inhibiting this enzyme, the drug prevents the virus from maturing and producing infectious particles, thereby reducing viral load in patients with HIV.
Darunavir is also known by the brand name Prezista. It is being studied in combination with other antiretroviral agents such as cobicistat and ritonavir for the treatment of HIV-1 infection.