The purpose of the proposed study is to use a polymer based sustained release antiviral drug delivery system that can be implanted in patients for anti-HIV therapy. Such a device has been developed for treatment of CMV retinitis and was approved by the FDA. The long term goal is to prevent vertical transmission using a device similar to Norplant that could be implemented in the developing world.
Four specific aims were proposed in the phase I study. they are: (1) Produce a range of subcutaneous implants containing AZT and ddC; (2) measure and modify the in vitro release rates of the implants; (3) to test the effect of gamma sterilization on these implants; (4) to initiate stability studies. the device will then be tested in the FIV model in the phase II study.
Potential commercial application not available.
