IMPAACT MOCHA More Options for Children and Adolescents

Transcription

1 IMPAACT 2017 Phase I/II Study of the Safety, Acceptability, Tolerability, and Pharmacokinetics of Oral and Long-Acting Injectable Cabotegravir and Long-Acting Injectable Rilpivirine in Virologically Suppressed HIV-Infected Children and Adolescents MOCHA More Options for Children and Adolescents

2 Welcome to the webinar! The session will begin shortly. Please mute your phone line (*6) to improve sound quality during the session. Do not place your phone line on hold during the session. Reminder: Document this training!

3 MOCHA STUDY-SPECIFIC TRAINING WEBINAR: IMPAACT 2017 PHARMACY STAFF TRAINING 25 and 26 June

4 MOCHA: More Options for Children and Adolescents Phase I/II Study of the Safety, Acceptability, Tolerability, and Pharmacokinetics of Oral and Long-Acting Injectable Cabotegravir and Long-Acting Injectable Rilpivirine in Virologically Suppressed HIV-Infected Children and Adolescents Irene Rwakazina, PharmD, CCRP, RPh Protocol Pharmacist DAIDS Pharmaceutical Affairs Branch

5 Agenda Introduction to PAB & DAIDS Pharmacy Guidelines Study design Study products Storage & temperature monitoring of study products Ordering, shipment & receipt of study products Study product accountability & reconciliation Prescription requirements Study product preparation Study product labeling Wasted doses Study product return 5

6 PAB & Pharmacy Guidelines PAB: Pharmaceutical Affairs Branch within DAIDS/NIAID Protocol pharmacist/protocol team Study product section (section 5) Pharmacy Guidelines & Instructions for DAIDS Clinical Trials Networks (DAIDS Pharmacy Guidelines): standard pharmacy operations 6

7 IMPAACT 2017 Study Design Phase I/II, multi-center, open-label, non-comparative study Purpose To confirm the dose and evaluate the safety, tolerability, acceptability, and pharmacokinetics of oral CAB, CAB LA, and RPV LA in virologically suppressed HIV 1 infected children and adolescents aged 12 to <18 years Participants Up to 155 adolescents aged 12 to <18 years Recruited in 2 consecutive cohorts (Cohort 1, followed by Cohort 2) 7

8 IMPAACT 2017 Participants in Cohort 1 will continue their pre-study cart Participants in Cohort 2 will discontinue their prestudy cart For both cohorts: oral lead-in period (4-6 weeks), followed by injectable dosing 8

9 Cohort 1 Cohort Step Study Product Regimen and Administration (with non-study provided cart regimen) 1 Oral CAB 30 mg once daily for 4-6 weeks 1C 2 CAB LA 600 mg/3 ml IM at Entry CAB LA 400 mg/2 ml IM at Week 8 and at Week 12 1 Oral RPV 25 mg once daily for 4-6 weeks 1R 2 RPV LA 900 mg/3 ml IM at Entry RPV LA 600 mg/2 ml IM at Week 8 and at Week 12 9

10 Cohort 2 Cohort Step Study Product Regimen and Administration (without cart regimen) 3 Oral CAB 30 mg once daily for 4-6 weeks AND Oral RPV 25 mg once daily for 4-6 weeks 2 4 First injection: CAB LA 600 mg/3 ml IM AND RPV LA 900 mg/3 ml IM Subsequent injections: CAB LA 400 mg/2 ml IM every four weeks through Week 96 AND RPV LA 600 mg/2 ml IM every four weeks through Week 96 10

11 Study-provided Products Oral CAB 30 mg tablets CAB LA 2mL vial (400mg) CAB LA 3mL vial (600mg)* Oral RPV 25 mg tablets RPV LA 2mL vial (600mg) RPV LA 3mL vial (900mg)* * 3mL vials will not be available initially 11

12 Oral CAB 30 mg oral tablets Provided in bottles containing 30 tablets Storage: up to 30 C, protect from moisture 12

13 Injectable CAB Long-acting (LA) formulation White to slightly pink suspension Supplied as 2mL (400 mg) and 3mL (600 mg) vials Storage: up to 30 C, do not freeze 13

14 Oral RPV 25 mg oral tablets Provided in bottles containing 30 tablets Storage: at 25 C, excursions permitted to C Keep tablets in original bottles to protect from light 14

15 Injectable RPV Long-acting formulation (LA) Sterile white suspension Supplied as 2mL (600 mg) and 3mL vials (900 mg) Storage: refrigerated at 2-8 C; protect from light, do not freeze 15

16 Light-Protection Sleeves To be placed on prepared RPV LA syringes to protect from light 16

17 Study Product Storage All study products should be stored in the investigational pharmacy at all times Pharmacy should be accessible only to authorized pharmacy staff, as specified in the site pharmacy SOP and Pharmacy Establishment Plan Study product storage conditions as per the protocol 17

18 Temperature Monitoring DAIDS Pharmacy Guidelines require TWO independent temperature monitoring devices for each storage area: primary (continuous) & back-up (min/max) - Data from back-up device to be used only if no data from primary device is available due to malfunction or other reasons Also required: alert system to notify the site pharmacist of out of range temperatures, especially after hours The pharmacist must be able to respond to alert quickly 18

19 Temperature Excursions Report temperature excursions to CRPMC using Temperature Excursion Reporting Form Instructions and address are on form Quarantine affected study products and wait for adjudication from the CRPMC: Return to inventory (separate from non-affected products) OR Quarantine for destruction 19

20 Drug Supply Statement (DSS) CRPMC receives notification of protocol registration (~24 hours later) CRPMC forwards DSS to the site pharmacist by Site pharmacist signs, dates, and returns DSS coversheet to the CRPMC as instructed Keep a copy of the DSS in your pharmacy files 20

21 Drug Supply Statement The following supplies are available from the Clinical Research Products Management Center (CRPMC). Note: We have been notified that your site has received protocol registration approval for this version of the protocol. You may now send an order. Once all required documents have been received, you will be notified when the shipment of study products will be made. DRUG SUPPLY STATEMENT IMPAACT 2017 Version 1.0 dated 1 March 2018 Recommended NSC Number Description (name, strength, formulation) Packaging Initial Order

22 Initial Study Product Order Place orders through CIOS - CRPMC Internet Ordering System US sites: Orders received before 4pm EST will be processed and shipped overnight the same day Initial Order: As shown on the DSS

23 Subsequent Orders All subsequent orders will be made in the same fashion as the initial order Evaluate and adjust based on enrollments & subsequent visits Site pharmacist is responsible to ensure sufficient study product on hand Don t overorder, in case of temperature excursions COMMUNICATION with clinic is KEY

24 Shipment & Receipt The CRPMC will ship study products at their appropriate recommended storage temperature Site pharmacists may receive multiple packages or shipments, based on temperature requirements Open the boxes immediately and follow the instructions that are provided Update accountability records accordingly Copy the protocol pharmacist on all communications with the CRPMC

25 Accountability In accordance with the DAIDS Pharmacy Guidelines, responsibilities of the site pharmacist include: Maintaining detailed records related to study product receipt, storage, dispensing, and final disposition Maintaining all study product-related documents in the pharmacy file Accountability Record forms are provided in the DAIDS Pharmacy Guidelines 25

26 Accountability Log in study products upon receipt from the CRPMC Log out study products prior to preparation and dispensing Double check entries, and if possible, have 2- person QC check in place Expiration dates for study products may NOT be available (as they might be under a continuous stability program) 26

27 Accountability 27

28 Prescription Requirements 28

29 Prescription Requirements Any information required by the jurisdiction in which you reside (e.g., name or initials) Authorized prescriber name, signature, and date signed Network name and protocol number (IMPAACT 2017) Participant identifier (PID) Study product to dispense (e.g. injectable CAB LA ) Quantity to dispense (e.g., 400 mg) Directions for use (e.g., IM in the gluteus medius) Visit number (e.g., Week 8) 29

30 Dispensing Oral Products Entry Visit (Cohorts 1 & 2): Dispense 30-day supply: Cohort 1: one bottle of CAB OR RPV (per study participant s assigned arm) Cohort 2: one bottle of CAB AND one bottle of RPV Week 2 or Week 4a (Cohorts 1 & 2): May dispense an additional 30-day supply to ensure sufficient coverage through the participant s scheduled Week 4b visit and first injection Short-term Oral Bridging (Cohort 2 Step 4 only): May dispense oral CAB and oral RPV, following consultation with the CMC 30

31 Injectable Study Product Preparation The site pharmacist must be proficient in the preparation of products requiring aseptic technique under a pharmacy biological safety cabinet or isolator Follow local regulations for individual protection measures (e.g., safety glasses, gloves, gowns, etc.) Refer to the MOP for detailed preparation information Monitors MUST be able to verify that the study product was prepared as directed in the protocol/mop 31

32 Study Product Labeling All study products will be labeled with a participant-specific label prior to dispensing Label must be in accordance with local regulations and the DAIDS Pharmacy Guidelines Key elements to include are listed in the DAIDS Pharmacy Guidelines Additional information as required by CRS jurisdiction 32

33 Study Product Administration CRITICAL - Clocks in Pharmacy and Clinic must be regularly synchronized to show the same time in both areas. This will avoid: Administration time appearing later than expiration time Study product being wasted even though it is still good 33

34 Study Product not ADMINISTERED??? 34

35 Unused syringe containing study product (i.e., Wasted Doses) In the event that a dose is prepared but not administered, the unused syringe(s) should be returned to the pharmacy for accountability, with a reason If a replacement dose is required, request a new prescription for this replacement dose Refer to the DSS for disposal instructions 35

36 Study Product Return All unused study products must be returned to the CRPMC after the study is completed or terminated, unless otherwise instructed by the study sponsor Study products may also be returned to the CRPMC prior to the completion or termination of the protocol for other reasons Forms and instructions will be provided by the CRPMC 36

37 Do you have everything in order? DAIDS PAB Approved Pharmacy Establishment Plan with approved modules: Bio-Safety Cabinet (Class II or better) Room temperature storage Refrigerated storage (2-8 C) Ancillary supplies (syringes, needles, light protection sleeves, etc.) Access to CIOS (study product order) Study-specific Communication/Chain of Custody SOP 37

38 Questions? If you have any questions, please feel free to contact me: TEL:

39 Documentation of Training Each pharmacy staff member who will provide any assistance for this study must complete the Certificate of Additional Training on the next slide Certificate of Additional Training must be kept by the site pharmacist in the pharmacy files 39

40 Certificate of Training IMPAACT 2017 V1.0 This signature page indicates that I have reviewed this Power Point presentation in its entirety. Furthermore, this signature page indicates that I have read the IMPAACT 2017 protocol and the DAIDS PAB Pharmacy Guidelines and Instructions for DAIDS Clinical Trial Networks manual and I understand the pharmacy requirements for this protocol. Date Signature Printed Name 40

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