Ocular syphilis in HIV-positive patients receiving highly active antiretroviral therapy.

Background: From October 2001 to October 2002, we have observed a surprisingly high incidence of ocular syphilis in human immunodeficiency virus-positive (HIV+) patients receiving highly active antiretroviral therapy at our clinic.

Methods: We conducted a retrospective chart and patient database review.

Results: From 1997 to 2002, 455 patients in our clinic were screened for syphilis; 320 were screened from 2001 to 2002; 7.

Reporting of deaths during pre-approval clinical trials for advanced HIV-infected populations.

The Division of Antiviral Drug Products of the US FDA has regulatory authority over the investigational new drugs under development by various sponsors to treat HIV-infected populations. The FDA and the sponsors of investigational new drugs use the Code of Federal Regulations to guide the entire drug development process, in order to ensure that safe and efficacious drugs are brought to market. To achieve this goal, diligent monitoring for safety during the pre-approval phase of new drug development is particularly crucial.