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Rilpivirine/Emtricitabine/Tenofovir

Phase 2

HIV | Small molecule | Infectious Disease |Gilead Sciences, Inc.|Last Updated: Mar 17, 2021

Target and mechanism

ModalitySmall molecule

Also known as Rilpivirine

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment150

FDA Designations

No designations recorded

Clinical trial landscape

Rilpivirine/Emtricitabine/Tenofovir · 1 trial · 1 indication

Phase 2 1
NCT02104700Switch From Nevirapine-based Regimen to Once a Day Rilpivirine/Emtricitabine/TenofovirHIV
COMPLETED150 Analytics
PHASE2COMPLETED
Switch From Nevirapine-based Regimen to Once a Day Rilpivirine/Emtricitabine/Tenofovir
HIVUnlock trial analytics

Study Endpoints

Primary Endpoints

Explore Efficacy
24 weeks

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.

Secondary Endpoints

HIV RNA levels
24 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Rilpivirine/Emtricitabine/TenofovirACTIVE_COMPARATOR"Immediate switch": RILPIVIRINE/ EMTRICITABINE /TENOFOVIR FDC QDAY at randomization.
Nevirapine/Lamivudine/ plus other NNRTIACTIVE_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.

Interventions

NameTypeDescription
Rilpivirine/Emtricitabine/TenofovirDRUGRilpivirine 25mg/Emtricitiabine 200mg/Tenofovir 300mg FDC qday
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

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 ...

Countries:Rwanda
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Frequently asked questions about Rilpivirine/Emtricitabine/Tenofovir

What is Rilpivirine/Emtricitabine/Tenofovir used for?

Rilpivirine/Emtricitabine/Tenofovir is an investigational small molecule combination therapy being studied for the treatment of HIV. It is in Phase 2 clinical development, with one completed trial that enrolled 150 participants in Rwanda. The drug is not yet approved and remains under clinical investigation.

What does Rilpivirine/Emtricitabine/Tenofovir target?

Rilpivirine/Emtricitabine/Tenofovir is a combination of three antiretroviral agents: rilpivirine, emtricitabine, and tenofovir. These components work by inhibiting HIV reverse transcriptase, an enzyme essential for viral replication. This targeted mechanism is being evaluated in the treatment of HIV infection.

Who makes Rilpivirine/Emtricitabine/Tenofovir?

Rilpivirine/Emtricitabine/Tenofovir is being developed by Gilead Sciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol GILD. The company is conducting clinical research to evaluate this combination therapy for HIV.

What phase is Rilpivirine/Emtricitabine/Tenofovir in?

Rilpivirine/Emtricitabine/Tenofovir is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied for safety and efficacy in treating HIV. One Phase 2 trial has been completed.

What clinical trials is Rilpivirine/Emtricitabine/Tenofovir in?

Rilpivirine/Emtricitabine/Tenofovir has one completed clinical trial registered as NCT02104700, titled "Switch From Nevirapine-based Regimen to Once a Day Rilpivirine/Emtricitabine/Tenofovir." This Phase 2 study enrolled 150 adults with HIV in Rwanda and was actively controlled, comparing the switch to a nevirapine-based regimen.

Is Rilpivirine/Emtricitabine/Tenofovir the same as Rilpivirine?

Rilpivirine/Emtricitabine/Tenofovir is a combination product that includes rilpivirine as one of its three active components, along with emtricitabine and tenofovir. While rilpivirine is a single antiretroviral agent, the combination product is a distinct fixed-dose formulation being studied for HIV treatment.