Study Medications Clause Samples

Study Medications. All study medications are for investigational use only and are to be used only within the context of this study. The Sponsor will supply all study medications. BA058 80 µg, Placebo and teriparatide will be supplied by the Sponsor. Pen devices and needles for administration of study medications also will be supplied to the study sites. BA058 80 µg for Injection: Each multi-dose cartridge contains 2 mg/mL BA058 (free base) in 5 mg/mL tri-hydrate sodium acetate and 5 mg/mL of phenol (preservative) adjusted at pH 5.1 with acetic acid. BA058 80 µg is supplied as a liquid in a 1.5 mL Type 1 glass cartridge and is stored refrigerated at 5 ± 3ºC. The multi-dose cartridge is designed to deliver a dose of 80 µg of BA058 in 40 µL of fluid when inserted into the Pen Injector device. The pen is also capable of delivering a half dose of BA058, or 40 µg of BA058 in 20 µL of fluid, with appropriate manual adjustment. When in use, multi-dose cartridges of BA058 80 µg can be stored for up to 30 days at room temperature. When used with the supplied pen and needles, each cartridge may be used to deliver study medication at the required daily dose for 30 days. Patients will be provided with a sufficient number of cartridges to continue on treatment until the next scheduled return to the study site.

Study Medications. The Step 1 initial treatment regimens in A5208/OCTANE will consist of TDF and FTC, combined with either LPV/RTV or NVP. The TDF/FTC backbone was chosen for several reasons: 1) Combinations of TDF, FTC, and an NNRTI or PI are extremely potent and have been associated with substantial virologic response rates in several studies in treatment-naïve patient populations. 2) TDF and FTC can be taken QD, which is likely to enhance adherence. 3) TDF should be well-tolerated; it is less likely to be associated with anemia than ZDV-based regimens and less likely to be associated with facial wasting and/or lipid metabolism dysregulation than d4T-based regimens. Although ZDV- and d4T-based regimens are currently more widely available in settings in which this study will be undertaken, it is anticipated that TDF will be readily available in the near future and experience with it in settings where ZDV- and d4T-associated resistance mutations are being selected will be critical. Gilead announced in April 2003 the Gilead Access Program, which will provide access to TDF at no profit in every country in Africa and in 15 additional countries in other parts of the world classified as "least developed" by the United Nations (UN). It will be important to gain clinical experience with TDF as this drug becomes more available in the developing world. WHO guidelines acknowledge that PIs are an accepted standard of care as part of first-line ART regimens, and that “advantages of PI-based regimens …are proven clinical efficacy and well described toxicities” [WHO, 2003]. Disadvantages include cost, heat instability (with certain PIs), and drug interactions with medications such as rifampin, which is used in tuberculosis (TB) treatment regimens. If, however, a PI-based regimen is shown to be of significantly superior efficacy than an NNRTI-based regimen, particularly among women who previously took SD NVP, then PIs may replace NNRTIs in first-line regimens for at least a subset of persons requiring ART in developing nations. Since late 2002, as significant strides have been made in price reductions for several PIs, these agents are becoming more readily available. LPV/RTV has recently been chosen by the government national ART programs of both Botswana and South Africa to become the PI of choice on their formularies. With increasing documentation of NNRTI resistance in the HIV-infected population in the United States [Little, 2002], which is likely to follow elsewhere with increasing us...