Study Drug Administration. Please refer to Section 9.10.13 for details on study drug administration. Clear instructions will be provided to the patient regarding the number and type of capsules to be ingested at each study drug administration time point listed in Table 4. Patients must be instructed to continue taking study drug once daily up through their Week 48 visit and from Week 52 to Week 100 unless:
(1) the patient has been otherwise instructed by the investigator or (2) the patient has been formally discontinued from study treatment.
Study Drug Administration. 5.1.3.1 NVP: one 200-mg tablet will be administered orally once daily for the first 14 days (lead-in period), then orally twice daily thereafter. In Step 1, NVP must be ingested in the morning during the lead-in period. The site clinician should review the signs and symptoms of NVP-related hypersensitivity and hepatitis with the participant prior to dispensing NVP. Participants should contact the site clinician as soon as possible if they develop rash, or signs and symptoms of hypersensitivity or hepatitis. If rash occurs during the lead-in period, do not escalate the dose until the rash has resolved. After reaching full dose, if NVP dosing is interrupted for >7 days, NVP should be started with the lead-in of 200 mg once daily for 14 days, then 200 mg twice daily. NVP may be taken with or without food. The lead-in period for NVP must never exceed 28 days. If the lead-in dosing period for NVP exceeds 28 daysd, then an alternate treatment must be sought. LPV/RTV: three soft-gel capsules (133.3 mg of LPV and 33.3 mg of RTV per capsule) will be administered orally twice daily with food. LPV/RTV: two fixed-dose combination tablets (each tablet contains 200 mg of lopinavir and 50 mg of ritonavir) orally twice daily with or without food. Tablets should be swallowed whole and not chewed, broken, or crushed. Lopinavir/ritonavir tablets will be available for all subjects who enroll under Version 3.0. Subjects who enrolled prior to Version 3.0 (i.e., before LPV/RTV tablets were available) may elect to switch from LPV/RTV capsules and receive the LPV/RTV tablets through A5208 at the time they consent to Version 3.0. A new prescription for the LPV/RTV tablets must be written in order for the pharmacist to dispense the new formulation.
Study Drug Administration. Patients should self-administer one capsule from each bottle included in the study drug kit orally once a day, preferably in the morning, as indicated in Table 3. On days when PK samples are collected, patients must not self-administer study drug. Study staff will administer study drug at the clinic following collection of the first PK sample. At the Week 24 visit, patients who opt to participate in a sub-study of 24-hr PK must not administer study drug before either day of the Week 24 visit. On the second day of the Week 24 visit, patients must administer study drug after the 24-hr PK blood collection has been performed. A vomited dose must not be replaced. A double dose (e.g., missed dose from previous day and dose for current day) must not be taken.
Study Drug Administration. Prior to starting the injection procedure, RBM-007 should have been prepared as described in Section 7.4 and Section 7.5, and the study eye should have been prepared as described in Section 7.6. • The entry site for injection is 4.0 mm posterior to the corneal limbus. A caliper may be used to identify the needle entry site. • Insert the needle perpendicular to the eye wall at the location specified in Step 2 (Section 7.7) to inject the study solution into the vitreous cavity. Note: If paracentesis is considered necessary, it should be performed prior to injection of the RBM-007 and noted in the source documents. • Very slowly, inject the entire RBM-007 dose volume (50 µL or 100 µL) and slowly withdraw the needle. Do not pull back on the plunger at any time prior to withdrawing the needle. • Briefly apply pressure for approximately 30 seconds to the needle entry site with sterile cotton tipped applicator (may be skipped per Clinical Investigator's discretion). • Remove the eyelid speculum and rinse the eye with sterile eye wash solution. • Patch the study eye at the Clinical Investigator's discretion. • Prescribe fluoroquinolone equivalent antibiotic eye drops three times/day for two days following injection, to be initiated as soon as possible.
Study Drug Administration. The intravitreal injection procedure using the pre-filled syringe should be carried out under controlled aseptic conditions. Adequate anaesthesia and a broad-spectrum microbicide should be given prior to the injection. Using aseptic technique, The study drug will be given by intravitreal injection 3.5 to 4mm posterior to the corneal scleral limbus. Following the intravitreal injection, subjects will be monitored for elevation in IOP and for endophthalmitis up to one-hour post-injection. Subjects should be instructed to report any symptoms suggestive of endophthalmitis without delay.
Study Drug Administration. Patients under the age of 18 should self-administer one capsule from each bottle included in the study drug kit orally every other day for the first week after randomization, and begin dosing once a day on Day 7 through the end of the study, as indicated in Table 4. Adult patients (≥ 18 years of age) should self-administer one capsule from each bottle included in the study drug kit orally once a day beginning on Day 1 through the end of the study, as indicated in Table 4. Each dose of study drug should be administered at approximately the same time each day, preferably in the morning. On days when PK samples are collected, patients must not self- administer study drug. Study staff will administer study drug at the clinic following collection of the first PK sample.
