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Tenofovir DF

Phase 3

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment152

FDA Designations

No designations recorded

Clinical trial landscape

Tenofovir DF · 1 trial · 1 indication

Phase 3 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
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

Study Endpoints

Primary Endpoints

Antiviral efficacy by HIV RNA
72 wks
Incidence of adverse events
72 wks

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
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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 States
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Frequently asked questions about Tenofovir DF

What is Tenofovir DF used for?

Tenofovir DF is a small molecule drug being developed for the treatment of HIV Infection. It is currently in Phase 3 clinical development as an investigational therapy for this infectious disease indication.

Who makes Tenofovir DF?

Tenofovir DF is being developed by Abbott Laboratories, a company traded on the stock exchange under the ticker symbol ABT.

What phase is Tenofovir DF in?

Tenofovir DF is currently in Phase 3 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities for the treatment of HIV Infection.

What clinical trials is Tenofovir DF in?

Tenofovir DF has one completed Phase 3 clinical trial, identified as NCT00234910. This trial evaluated the efficacy of a simplified two-drug Kaletra regimen compared to a Kaletra triple-drug standard of care regimen in treatment-naive HIV infected patients.

Is Tenofovir DF the same as Kaletra?

Tenofovir DF is not the same as Kaletra. In the clinical trial NCT00234910, Tenofovir DF was part of a regimen that included Kaletra, but they are distinct drugs used in combination for the treatment of HIV Infection.