Antiviral Product Development–Conducting and Submitting Virology Studies to the Agency: Guidance for Submitting HIV Resistance Data

Issue Date: June 2, 2006
Issued by: Center for Drug Evaluation and Research
Topic(s): Clinical – Antimicrobial
Status: Final

Antiviral Product Development–Conducting and Submitting Virology Studies to the Agency: Guidance for Submitting HIV Resistance Data

Sponsors are encouraged to use the following sample format for submitting HIV resistance data. One dataset combines patient data, endpoint data, genotypic data, and phenotypic data. There are a number of ways datasets can be subdivided (i.e., by clinical study, baseline isolates, or virologic failure isolates) and this should be discussed with the division before submission.

Download the Guidance Document