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Label indication COMPLERA ® is indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 35 kg: as initial therapy in those with no antiretroviral treatment history with HIV-1 RNA less than or equal to 100,000 copies/mL at the start of therapy or to replace a stable antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a… FDA label
Also known as Rilpivirine, Complera
Rilpivirine/Emtricitabine/Tenofovir · 1 trial · 1 indication
To compare proportion of subjects successfully maintaining a plasma viral load \<200 copies /mL at week 24 in subjects randomized to rilpivirine/emtricitabine/tenofovir vs. in those randomized to initially continue nevirapine-based ART in this pilot study.
| Arm | Type | Description |
|---|---|---|
| Rilpivirine/Emtricitabine/Tenofovir | ACTIVE_COMPARATOR | "Immediate switch": RILPIVIRINE/ EMTRICITABINE /TENOFOVIR FDC QDAY at randomization. |
| Nevirapine/Lamivudine/ plus other NNRTI | ACTIVE_COMPARATOR | "Delayed switch": Continue NEVIRAPINE 200MG BID + LAMIVUDINE 300MG + OTHER NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITOR (NRTI) through 24 weeks then switch to RILPIVIRINE 25MG/ EMTRICITABINE 200MG/TENOFOVIR 300MG FDC QDAY and then follow through 48 weeks. |
| Name | Type | Description |
|---|---|---|
| Rilpivirine/Emtricitabine/Tenofovir | DRUG | Rilpivirine 25mg/Emtricitiabine 200mg/Tenofovir 300mg FDC qday |
Inclusion Criteria: * HIV-1 infection, as documented by any licensed ELISA test kit and confirmed by Western blot at any time prior to study entry. A second antibody test by a method other than ELISA is acceptable as an alternative confirmatory test or a previous detectable HIV RNA level * HIV RNA ...
Rilpivirine/emtricitabine/tenofovir is a once-daily small molecule combination being studied for the treatment of HIV. It combines three antiretroviral agents in a single regimen. Gilead Sciences, Inc. (ticker GILD) is the developer. The combination has been evaluated in a Phase 2 clinical trial in HIV-positive adults.
Rilpivirine/emtricitabine/tenofovir is being developed as a once-daily treatment regimen for HIV infection. It is intended for use in adults living with HIV, including as a switch option for patients already on antiretroviral therapy. The studied population was adults 18 years and older.
Gilead Sciences, Inc. is the developer of rilpivirine/emtricitabine/tenofovir. The company trades on the Nasdaq under the ticker GILD. Gilead is responsible for the clinical development of this fixed combination for HIV.
Rilpivirine/emtricitabine/tenofovir is in Phase 2 development for HIV. It is investigational and has not been approved by the FDA. The Phase 2 program includes one completed trial, and no trials are currently active.
Rilpivirine/emtricitabine/tenofovir has been studied in one completed Phase 2 trial, NCT02104700, titled Switch From Nevirapine-based Regimen to Once a Day Rilpivirine/Emtricitabine/Tenofovir. The trial enrolled 150 adults with HIV in Rwanda and used an active-controlled, randomized design.
Rilpivirine/emtricitabine/tenofovir is also known as rilpivirine, but the two names are not fully interchangeable. Rilpivirine refers to one component of the three-drug combination, while the full name describes the complete fixed-dose regimen containing rilpivirine, emtricitabine, and tenofovir.