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NCT00543725 - A Phase III, Randomized, Double-blind Trial of TMC278 25mg q.d. Versus Efavirenz 600mg q.d. in Combination With a Background Regimen Containing 2 Nucleoside/Nucleotide Reverse Transcriptase Inhibitors in Antiretroviral-naive HIV-1 Infected

A Phase III, Randomized, Double-blind Trial of TMC278 25mg q.d. Versus Efavirenz 600mg q.d. in Combination With a Background Regimen Containing 2 Nucleoside/Nucleotide Reverse Transcriptase Inhibitors in Antiretroviral-naive HIV-1 Infected Subjects.


Data Specification

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Annotated CRF

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Product Info

Generic Name
Rilpivirine
Product Name
EDURANT®
Therapeutic Area
Immune System Diseases
Enrollment
680
% Female
27.1%
% White
61.0%
Product Class
Antiviral Agent
Sponsor Protocol Number
TMC278-TIDP6-C215
Data Holder
Johnson & Johnson
Condition Studied
HIV Infections
Mean/Median Age (Years)
36.0

Supporting Documentation

Data Definition Specification Available
Annotated Case Report Form Available
Clinical Study Report
Collected Datasets
Data Definition Specification
Protocol with Amendments
Statistical Analysis Plan
Study Phase 
3

Disclaimer

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