Regulatory issues in developing new HIV protease inhibitors: risks and benefits.
OBJECTIVE
To provide a regulatory perspective on developing new HIV protease inhibitors. The present review highlights the risks and benefits of certain design aspects for studies in treatment-naïve and treatment-experienced patients, including timing of studies, study design options, choice of control arms, and duration of treatment.


RESULTS
The present review highlights published studies to illustrate the need for new therapies and highlights potential historical data to help design future HIV clinical trials better.


CONCLUSIONS
New antiretroviral agents for patients with multidrug resistance, including safer, more convenient therapies without significant drug-drug interactions, are still needed for all patients. The goals of therapy have evolved and the expectation for treatment regimens is that the majority of patients, including treatment-experienced patients, will achieve undetectable HIV RNA. New study designs, particularly for treatment-experienced patients, are needed to help identify potential risks and benefits of new treatments.
Struble
Kimberly A
KA
Office of New Drugs, Office of Antimicrobial Products, Division of Antiviral Products, US Food and Drug Administration, USA. Kimberly.struble@fda.hhs.gov
Chan-Tack
Kirk M
KM
Soon
Guoxing Greg
GG