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Drug Development
Emerging Issues in Clinical Trials for New ARV Development

SEP-30-10 The present success in treating HIV and availability of a number of therapeutic alternatives on the market poses a dilemma for the clinical development of new ARVs: how to evaluate the contribution of an investigational agent in HIV clinical trials in the presence of a fully suppressive ARV regimen.

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2009 Update on Rethinking Approaches to Expanded Access Programs
NOV-18-09  The Forum reconvened key stakeholders to continue discussions on HIV Expanded Access Programs following the release of the revised FDA regulations on "Expanded Access to Investigational Drugs for Treatment Use."
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Re-Thinking the Design of Clinical Trials for the Development of New ARVs
JAN-10-08  While the palette of drugs from which to construct a regimen is significantly more expansive than it was in the past, the HIV community remains in need of additional new drugs to treat drug resistant virus as well to ensure safety and tolerability for all populations.
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Rethinking the Approach to Expanded Access Programs
FEB-16-07  Expanded access programs have been a critical component of HIV drug development that ensures people at late stage HIV disease have early access to new therapies. Most HIV drugs have been made available through expanded access programs while the drug is in phase III clinical studies.
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Accessing Drugs for Clinical Research in Resource Limited Settings
SEP-19-05  This project focuses on the challenges and issues in accessing drugs for clinical research in the resource limited setting.
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Salvage Therapy II

APR-16-04  There is a growing population of treatment-experienced “salvage” patients for whom there are limited or no viable treatment options left to combat HIV.

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Anti-viral Therapy and Salvage Therapy
Treatment failure can occur for multiple reasons - poor adherence, poor absorption, sub-optimal anti-viral therapy, etc. To address these issues, the Forum has focused on how and why therapy fails people, the design of clinical studies to develop salvage therapy regimens, and the need for studies to understand the long-term clinical effectiveness of anti-viral therapies.
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