About Case Studies

Clinical Pharmacology Quality Assurance Program

The Clinical Pharmacology Quality Assurance (CPQA) Program provides a multifaceted approach to ensure that National Institute of Allergy and Infectious Diseases (NIAID) Division of Acquired Immunodeficiency Syndrome (DAIDS)-supported networks conduct the highest quality of clinical pharmacology research. The CPQA includes quality management initiatives that incorporate: Cross Network Laboratory Groups: Clinical Pharmacology Initiatives, Quality Management and Proficiency Testing, Development and Validation of Pharmacology Assays, Domestic/International Pharmacology Lab Participation, Analytical Reference Powders, Laboratory Staff Training, Site Inspections and Audits and Dissemination of Technical and Scientific Data.

Additional information can found at cpqaprogram.org.

Investigational Agents

ACTG research protocols may involve FDA approved medications and investigational agents. Research in several common comorbid infections as well as HIV reservoirs has grown rapidly. PPMD expands with these areas of investigation to facilitate protocol development.

ACTG Pharmacology Specialty Laboratories

The ACTG Laboratory Network includes domestic and international Pharmacology Specialty Laboratories. The international laboratories are located at the University of Cape Town and the University of Zimbabwe.

Pharmacogenomics

Pharmacogenomics is a rapidly growing field of research that is likely to have a considerable impact on our understanding of the mechanisms that underlie drug interactions. As the number of pharmacogenomics abstracts at scientific conferences increases, the drug interactions database will expand to include important new data that provide an understanding of how single nucleotide polymorphisms, epigenetics and protein expression may influence protocol design and planning.

Regional use of Traditional Medicines

As the scope of research conducted through the ACTG and other HIV research networks expands to include international research centers, the regional use of traditional medicines will become an important factor in the design and conduct of these studies and the enrollment of local populations. The pharmacologic characteristics of traditional medicines as well as emerging clinical data regarding these phytomedicinals will be important for protocol design and the conduct of research studies in multiple geographic regions. The drug interactions database will expand to include this evidence for clinical investigators as new data arise.