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U.S. Department of Health and Human Services

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Final Guidance: The Role of HIV Resistance Testing in Antiretroviral Drug Development

The Food and Drug Administration is publishing final Guidance for Industry on the Role of HIV Resistance Testing in Antiretroviral Drug Development. This final guidance discusses the nonclinical studies (mechanism of action; antiviral activity in vitro; cytotoxicity/therapeutic index; and the effects of serum protein binding on antiviral activity) the agency recommends be completed prior to the initiation of phase 1 clinical studies in HIV-infected patients. In addition, the guidance addresses the use of resistance testing in the clinical phases of drug development and recommends the type of information that should be collected and the types of analyses that should be conducted to characterize an antiretroviral's resistance profile.

The guidance also discusses the role of resistance testing in initial activity and dose-finding, for study enrollment criteria, for background regimen selection, and to establish an indication.

The guidance represents the agency's current thinking on the role of HIV resistance testing in antiretroviral drug development. As with all FDA guidance for industry, it does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations.

You can find this Guidance for Industry on the FDA web site.

Richard Klein
Office of Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration