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NCT00355524 - A Phase II, Open-label Trial, to Investigate Pharmacokinetics, Safety, Tolerability and Antiviral Activity of TMC114/Rtv b.i.d in Treatment-Experienced HIV-1 Infected Children and Adolescents

A Phase II, Open-label Trial, to Investigate Pharmacokinetics, Safety, Tolerability and Antiviral Activity of TMC114/Rtv b.i.d in Treatment-Experienced HIV-1 Infected Children and Adolescents


CSR Summary

Not Yet Available


Data Specification

Not Available


Annotated CRF

Available upon data request approval

Product Info

Generic Name
Darunavir
Product Name
PREZISTA®
Therapeutic Area
Immune System Diseases
Enrollment
80
% Female
29.0%
% White
63.0%
Product Class
Antiviral Agent
Sponsor Protocol Number
TMC114-C212
Data Partner
Johnson & Johnson
Condition Studied
HIV Infections
Mean/Median Age (Years)
14.0

Supporting Documentation

Clinical Study Report
Collected Datasets
Annotated Case Report Form
Protocol with Amendments
Statistical Analysis Plan
Study Phase 
2

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.