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NCT01876966 - A Phase I, Partially Randomized, Open Label, Two-way, Two Period Cross-over Study to Investigate the Pharmacokinetic Interaction Between Etravirine or Darunavir/Rtv and Artemether/Lumefantrine at Steady-state in Healthy HIV-negative Subjec

A Phase I, Partially Randomized, Open Label, Two-way, Two Period Cross-over Study to Investigate the Pharmacokinetic Interaction Between Etravirine or Darunavir/Rtv and Artemether/Lumefantrine at Steady-state in Healthy HIV-negative Subjects


Data Specification

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Annotated CRF

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Product Info

Generic Name
Etravirine
Product Name
INTELENCE®
Therapeutic Area
Immune System Diseases
Enrollment
33
Product Class
Antiviral Agent
Sponsor Protocol Number
TMC125VIR1001
Data Holder
Johnson & Johnson
Condition Studied
HIV Infections

Supporting Documentation

Analysis Datasets
Annotated Case Report Form (CRF)
Clinical Study Report
Collected Datasets
Protocol with Amendments
Statistical Analysis Plan
Study Phase 
1

Disclaimer

Clinical study data provided through this site do not replace the official labeling of a given drug product, which presents benefits and risks of the product for approved use(s). Before prescribing any product, health care professionals should consult the current prescribing information approved in their country. Patients seeking information may consult with their health care professional about the product, for which health authority approved written patient information may be available.