Guidance for Industry on Antiretroviral Drugs Using Plasma Human Immunodeficiency Virus Ribonucleic Acid Measurements-Clinical Considerations for Accelerated and Traditional Approval; Availability

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The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Antiretroviral Drugs Using Plasma HIV RNA Measurements--Clinical Considerations for Accelerated and Traditional Approval." This guidance is intended to assist sponsors in the clinical development of drugs for the treatment of human immunodeficiency virus (HIV) infection. Specifically, this guidance addresses the agency's current thinking regarding designs of clinical trials that use HIV ribonucleic acid (RNA) measurements to support accelerated and traditional approvals of antiretroviral drug products.