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Tenofovir DF

Phase 4

HIV Infection | Small molecule | Infectious Disease |Abbott Laboratories|Trials Updated: Jul 10, 2008

Tenofovir DF development status

Highest phase Phase 4 run by Gilead Sciences (NCT02479880)
Phase scored for ABTPhase 3
Registered trials 14 across 3 sponsors since May 2002

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials3
Total Enrollment392

FDA Designations

No designations recorded

Tenofovir DF clinical trials

Tenofovir DF · 3 trials · 2 indications

Phase 3 2Phase 2 1
NCT00234910Efficacy of Simplified Two Drug Kaletra Regimen vs. Kaletra Triple Drug Standard of Care Regimen in Treatment naïve HIV Infected PatientsHIV Infection
COMPLETED152 Analytics
NCT00043966Study of Lopinavir, Ritonavir, Tenofovir and Emtricitabine in HIV-Infected Antiretroviral Naïve SubjectsHIV Infections
COMPLETED200 Analytics
PHASE3COMPLETED
Efficacy of Simplified Two Drug Kaletra Regimen vs. Kaletra Triple Drug Standard of Care Regimen in Treatment naïve HIV Infected Patients
HIV InfectionUnlock trial analytics
PHASE3COMPLETED
Study of Lopinavir, Ritonavir, Tenofovir and Emtricitabine in HIV-Infected Antiretroviral Naïve Subjects
HIV InfectionsUnlock trial analytics

Study Endpoints

Primary Endpoints

Antiviral efficacy by HIV RNA
72 wks
Incidence of adverse events
72 wks
Proportion of subjects with plasma HIV RNA level below 50 copies/mL at week 48
Proportion of subjects in each group demonstrating complete suppression of viral replication at Week 144.

Secondary Endpoints

Adherence and quality of life
72 wks
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AEXPERIMENTAL2 drug arm
BACTIVE_COMPARATOR3 drug arm, SOC

Interventions

NameTypeDescription
Tenofovir DFDRUGTDF 300mg QD for 72 wks
lopinavir/ritonavir with 2 Nucleoside RTIsDRUGLPV/rSGC 400/100mg BID + 2 nucleoside RTIs as prescribed by the Investigator for 72 wks
Lopinavir/ritonavirDRUG -
EmtricitabineDRUG -
EfavirenzDRUG -
LamivudineDRUG -
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Eligibility Criteria

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

Inclusion Criteria: * HIV positive * \>18 years of age * HIV RNA\> 400 copies/mL * Any CD 4 cell count * Antiretroviral naïve * No acute illness Exclusion Criteria: \-

Countries:United StatesAustraliaFranceGermanySingaporeSpainUnited Kingdom
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Frequently asked questions about Tenofovir DF

What is Tenofovir DF used for?

Tenofovir DF is used for the treatment of HIV Infection. It is an infectious disease therapy studied in antiretroviral regimens for HIV-infected patients, including treatment-naive adults. The clinical program enrolled 392 participants across completed Phase 2 and Phase 3 studies.

Who is developing Tenofovir DF?

Tenofovir DF is being developed by Abbott Laboratories, which trades under the ticker ABT. Abbott Laboratories sponsored the clinical trials evaluating Tenofovir DF in HIV Infection, including studies combining it with other antiretroviral agents such as lopinavir, ritonavir, and emtricitabine.

What phase is Tenofovir DF in?

Tenofovir DF is in Phase 3 development for HIV Infection. Three clinical trials have been completed, including two Phase 3 studies and one Phase 2 study. No trials are currently active. The studies together enrolled 392 participants and used active-controlled, randomized designs.

What clinical trials is Tenofovir DF in?

Tenofovir DF has been studied in three completed trials: NCT00234910, a Phase 3 study of a simplified two-drug Kaletra regimen versus a Kaletra triple-drug standard of care regimen in treatment-naive HIV-infected patients; NCT00043966, a Phase 3 study of lopinavir, ritonavir, tenofovir, and emtricitabine in antiretroviral-naive subjects; and NCT00038220, a Phase 2 study of ABT-378/ritonavir plus lamivudine, efavirenz, and Tenofovir DF.

Is Tenofovir DF FDA approved?

Tenofovir DF is an investigational therapy in clinical development for HIV Infection, with Phase 3 trials completed. The available information does not indicate FDA approval status. It has been evaluated in randomized, active-controlled studies, including combination regimens with other antiretroviral agents.