Skip to main content

NCT00258557 - Phase III Randomized, Controlled, Open-label Trial to Investigate the Antiviral Activity, Tolerability and Safety of TMC114/r in Treatment- Naive HIV-1 Infected Patients

Phase III Randomized, Controlled, Open-label Trial to Investigate the Antiviral Activity, Tolerability and Safety of TMC114/r in Treatment- Naive HIV-1 Infected Patients


Data Specification

Not Available


Annotated CRF

Not Available

Data Request Dashboard

Operations

No data requests found. Click here to generate a new one.

Product Info

Generic Name
Darunavir
Product Name
PREZISTA®
Therapeutic Area
Immune System Diseases
Enrollment
692
% Female
30.0%
% White
42.0%
Product Class
Antiviral Agent
Sponsor Protocol Number
TMC114-C211
Data Holder
Johnson & Johnson
Condition Studied
HIV Infections
Mean/Median Age (Years)
34.0

Supporting Documentation

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

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.