Pediatric Randomized of Early vs Deferred Initiation in Cambodia and Thailand

Transcription

1 Pediatric Randomized of Early vs Deferred Initiation in Cambodia and Thailand (PREDICT STUDY) Present by Dr. KEA CHETTRA, Study Coordinator December 16th, 2008

2 What is PREDICT STUDY? An open - label, randomized, phase III study. Antiretroviral (ARV)-naïve children ages 1 to 12 years with CDC pediatric clinical classification category A or B and CD4 between 15 to 24 percent are randomized 1:1 to starting HAART immediately (immediate arm). Non- IND Protocol

3 Sponsoring Agency Sponsored by The National Institute of Allergy and Infectious Diseases

4 Objective Primary objective: To compare AIDS-free survival distributions up to wee 144 between the two arms. Secondary objective: To compare the following endpoint between two arms Average cost of treatment per patient including direct cost and indirect cost Number and duration of hospitalization ARV-related toxicity Number of changes of antiretroviral regimens Number of HIV-related clinical events Number of minor infectious episodes and antibiotic use.

5 Objective Number of children with virological failure Chang of growth in Z score from baseline and week 144 Change in CD4 percent from baseline to week 144, and time weighted average change from baseline over 144 weeks Proportion of children with CD4 < 10 percent at wee 144 Quality of life Adherence to ARV Iron status in relationship to the immunologic effects of HIV T cell subsets Cytotoxic T lymphocyte activity HIV viral sequence HIV viral replication

6 Chiang Rai Hospital PI: Rawiwan hansudewechakul,, MD. Khon Kaen Hospital PI: Pope Kosalaraksa, MD. Nakornping Hospital PI: Suparat Kanjanavanit, MD. National Pediatric Hospital PI: Saphonn Vonthanak, MD.,Ph.D. Social Health Clinic PI: Saphonn Vonthanak, MD.,Ph.D Bamrasnaradura Institute PI: Jurai Wongsawat,, MD. HIV-NAT PI: Kiat Ruxrungtham, MD Queen Sawangwattana Memorial Hospital PI: Wicharn Luesomboon,, MD. Chonburi Hospital PI: Suchat Hongsiriwan,, MD.

7 Study Participants First enrollment on October 3rd, 2006 Last enrollment on June 12th, 2008 Enrolled 120 for both sites: NPH enrolled 83 participants SHC enrolled 37 participants 03 participants withdrew from the study as of mid-december 2008

8 Process to start screening patient Site Assessment by sponsor Establish study team Training Infrastructure Site Assessment by independence company Complete pending issues Assessment by independence company Approval to start screening patient by sponsor

9 Site Assessment Pharmacy Storage laboratory Facility Phlebotomy space Study Site Emergency equipment Counseling Room/Informed Consent

10 Study Team PI Investigator and back up SN and back up Counselor and back up Pharmacist and back up Lab technician and back up Coordinator

11 Training Protocol Informed consent Toxicity SOP MOP GCP GCLP HSP Data Management

12 Infrastructure Computer Internet Telephone Fax scan machine Refrigerator Pharmacy room s thermometer Refrigerator s thermometer Thermometer alarm system Humidifier Generator

13 Challenges International regulation FWA IRB Local regulation NEC Laboratory Capacity building PLHA community Orphan children

14 Challenges after 1st enrollment Informed Consent Screening Enrollment Time line for recruitment Data management Toxicity management Protocol deviation Protocol violation Managing patients after hour

15 Challenges after start screening patient Follow up Patient retention Staff retention Safety report and package insert Study medication Drug adherence QA/QC QM End of study

16 Challenges during the study Coordinate the sites Site support Regulatory Sites Site monitoring Sponsor

17 Result/Outcome Able to set up the quality research trial Staff received training within 3 months and able to perform according to the Good Clinical Practice (GCP) Highest recruitment (120 patients) compare to other sites Good adherence and withdraw <3% Competency is in place for all staff involved

18 Lesson Learn Build up capacity for Standard Clinical Research Local/international regulatory requirement To have and maintain infrastructure Recognized by internationally research sponsor QA/QC QM

19 THANK YOU