SeerPharma Pty Ltd :: DISCover web-based training :: HIV and AIDS: Clinical Development

HIV and AIDS: Clinical Development

Description: The human immunodeficiency virus, or HIV, is the virus that causes Acquired Immune Deficiency Syndrome (AIDS). HIV is a retrovirus, and is composed of a central core made of proteins and RNA, surrounded by an "envelope" or membrane made of other proteins and fatty acids. This course presents current regulatory guidelines for HIV treatment clinical trails with respect to study design and operational issues.

COURSE OUTLINE

INTRODUCTION
1. Course Information
2. Interface Tour
3. Course Overview

CLINICAL DEVELOPMENT
4. Objectives
5. Subject Selection
6. Study Length
7. Blinding and Study Procedures
8. Plasma HIV RNA Measurements
9. CD44 Cell Counts and Clinical Endpoints
10. Treatment Failure
11. Objective Measures of Failure
12. Treatment Options
13. Study Site and Patient Types
14. Ethical Issues and Follow-Up
15. Progress Check

CONCLUSION
16. Summary

COURSE OBJECTIVES

Students completing this course should be able to:

Describe the subject requirements of an HIV treatment trial
List the required study length times for an accelerated and traditional trial
Describe the most common endpoints for HIV therapy trials

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