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The George Washington University Medical Center

Drug Interaction Research

 

Report of Meeting on Drug Interaction Research in HIV Disease, April 2000

Background

As the number of medications that people with HIV disease continues to expand, the impact of the interactions between these drugs grows significantly. These interactions have tremendous impact on the effectiveness of anti-viral treatment regimens and other medications, can create additional toxicities, but , too often, the interactions are not well researched prior to or after marketing of the drugs. Designing studies and trials to research the interactions is especially challenging given the number of possible combinations.

Outlining a Strategy for Action

In April 2000, the Forum convened European and U.S. regulatory agencies, researchers, the pharmaceutical industry, and the patient advocate community to review the role of drug interaction studies in drug licensing from their four perspectives. The meeting was held on conjunction with the 1st International Workshop on Clinical Pharmacology and HIV Therapy and focused on four specific areas:

  • Role of drug interaction data in HIV drug licensing
  • Need for better exchange of data, drugs, and assays for drug interaction and pharmacology study
  • Methods to improve sharing of data, drugs, and assays
  • Steps necessary to validate therapeutic drug monitoring (TDM) as a clinical tool.

A full meeting report is available.

Creating a Better System for Sharing Investigational Agents

One issue discussed at the meeting was the great difficulty that independent investigators not aligned with a pharmaceutical company have in securing investigational compounds for drug interaction studies. Often the industry is wary of providing such agents to independent investigators because the compound may be studied in ways industry feels are not appropriate or in ways other than those originally proposed by the investigator.

The Forum agreed to seek ways to facilitate the sharing of investigational agents for drug interaction studies by acting as a conduit for requests to industry for the compounds.
The Forum is now in the process of developing an internet-based system to assist investigators seeking to undertake drug interaction studies by linking them with the appropriate contact persons at pharmaceutical companies.

 

Forum for Collaborative HIV Research
Department of Prevention and Community Health
School of Public Health and Health Services

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Washington, DC 20037
Phone: 202 530-2370
Fax: 202 530-3923
info@hivforum.org

The Forum for Collaborative HIV Research