June 10, 2013
The Food and Drug Administration recently published new Guidance for Industry: Human Immunodeficiency Virus-1 Infection: Developing Antiretroviral Drugs for Treatment
The new guidance provides recommendations for the development of antiretroviral drugs regulated within the FDA's Center for Drug Evaluation and Research (CDER) for the treatment of human immunodeficiency virus-1 (HIV-1 or HIV) infection. Specifically, this guidance addresses the overall development program and clinical trial designs for antiretroviral drugs to support an indication for the treatment of HIV-1 infection.
This guidance revises the October 2002 guidance for industry Antiretroviral Drugs Using Plasma HIV-RNA Measurements -- Clinical Considerations for Accelerated and Traditional Approval.
Significant changes from the 2002 version include:
This guidance does not address the use of antiviral drugs for preventing the transmission of HIV-1 infection, development of therapeutics (without antiviral mechanisms) intended to mitigate or reverse clinical or pathophysiological outcomes of immunologic suppression of HIV-1 infection, and general issues of clinical trial design or statistical analyses for HIV antiretroviral trials.
No comments have been made.