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UMTATA

UMTATA. UMTATA PHIDISA SITE UMTATA HEALTH CENTRE AREA MILITARY HEALTH UNIT-EASTERN CAPE DR SK CHIKWAVA UMTATA PRINCIPAL INVESTIGATOR 26.07.04. LOCATION. EASTERN CAPE PROVINCE- FORMER TRANSKEI (REGION D) UMTATA- 215KM FROM EAST LONDON, 465KM FROM DURBAN 14 SAI BATALLION

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UMTATA

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  1. UMTATA UMTATA PHIDISA SITE UMTATA HEALTH CENTRE AREA MILITARY HEALTH UNIT-EASTERN CAPE DR SK CHIKWAVA UMTATA PRINCIPAL INVESTIGATOR 26.07.04

  2. LOCATION • EASTERN CAPE PROVINCE-FORMER TRANSKEI (REGION D) • UMTATA-215KM FROM EAST LONDON, 465KM FROM DURBAN • 14 SAI BATALLION • ADMINISTERED BY AREA MILITARY HEALTH - EC

  3. SERVICE AREA • EASTERN CAPE- MAINLY UMTATA (RADIUS OF 300KM) • MALUTI DEPLOYMENT BASE • BARKLEY EAST DEPLOYMENT BASE

  4. INFRASTRUCTURE

  5. 2 %

  6. SITE PREPARATION • Target date - 04.10.04 • Stage one of four - completed on • 23.10.04 • Main hurdles - Human resources • - communication

  7. HUMAN RESOURCES PRINCIPAL INVESTIGATOR STUDY CO-ORDINATOR PATIENT ADMINISTRATOR MEDICAL PHARMACIST DIETICIANSOCIALPSYCHOLOGIST CASE LABAROTORY CHAPLIN OFFICER WORKER MANAGER ASSISTANT PHARMACIST ASSISTANTCOMMUNITY NURSE HEALTH WORKERS

  8. SCOPE OF STUDY • 277 REACTIVE PATIENTS AWAITING STUDY • 7 ALREADY ON ARVS – 1 MIL HOSPITAL PHIDISA • 15 ON PHIDISA ONE AWAITING P2

  9. PHIDISA II A Randomised, Open-Label 2x2 Factorial Study to Compare the Safety and Efficacy of Different Combination Antiretroviral Therapy Regimens in Treatment Naïve Patients with Advanced HIV Disease and/or CD4+ Cell Counts <200 cells/µL

  10. PHIDISA IITarget Population • Patients with advanced HIV disease:CD4+ < 200 cells/mm3 or symptomatic HIV disease • No prior antiretroviral treatment

  11. PHIDISA II Study Design 2,800 HIV-infected participants withCD4+ < 200 cells/mm3 or AIDS AZT + ddI + EFV AZT + ddI + r/LPV d4T + 3TC + EFV d4T + 3TC + r/LPV

  12. PHIDISA II: A 2 x 2 Factorial Design Factor 1 (NNRTI vs PI) Factor 2 (NRTIs) r/LPV EFV 700 1,400 700 AZT+ddI 700 700 1,400 d4T+3TC 1,400 1,400 2,800 2 factors, each at 2 levels

  13. PHIDISA II Sample Size • Target number of events – 635 • 2,800 participants followed for a median of 5 years (range 4-6 years) • 80% power to detect a 20% difference between main effects: • EFV versus rLPV • AZT + ddI versus d4T + 3TC

  14. PHIDISA II Enrollment by Month No. Patients Month

  15. PHIDISA IIEnrollment by Month and Site Percent Month

  16. PHIDISA II Enrollment Summary Targeted Enrollment Total number enrolled

  17. PHIDISA II Baseline Characteristics All Patients Age (mean years) 34.4 Female (%) 33.9 Location of home (% rural) 39.2 Home language (%) Isi-Zulu 34.3 Isi-Xhosa 16.5 Setswana 14.1 Sesotho 14.1 Other 21.0 Marital status (% married) 60.7 Customary marriage (%) 6.5 Education (% high school or tertiary) 94.3

  18. PHIDISA II Baseline Characteristics (cont.) All Patients Median CD4 cell count (cells/mm3) 95.0 Median HIV viral load (copies/mL) 170,000 HIV viral load (% > 100,000 copies/mL) 72.3 Hepatitis B co-infection (%) 7.7 Hepatitis C co-infection (%) 1.7 Weight (kg) Women 61.0 Men 64.1 WHO Stage IV (%) 5.0

  19. PHIDISA II Baseline CD4 Cell Count Distribution 25 Median: 95 cells/mm3 IQR: xx-xx cells/mm3 20 15 % of Participants 10 5 0 <25 25-49 50-74 75-99 >=200 100-124 125-149 150-174 175-199 Cells/mm3

  20. PHIDISA IIBaseline Viral Load Distribution Median: 170,000 copies/mL IQR: xx-xx copies/mL % of Participants Copies/mL

  21. PHIDISA IIWHO Clinical Stage % of Participants WHO Clinical Stage

  22. PHIDISA IIBaseline Hemoglobin by Gender Percent Hemoglobin

  23. PHIDISA IIOverall Health Rating Average rating = xxx % of Participants Overall Health Rating (0=worst possible health, 1=best possible health)

  24. PHIDISA IIBaseline Characteristics by Site Age (mean years) 34.5 34.1 Women (%) 37.9 12.5 CD4+ (median cells/mm3) 93 107 HIV RNA (log10 copies/mL) 5.26 5.13 WHO Stage IV (%) 4.2 10.0 Overall health (mean score) xxx xxx 1 Mil Mtubatuba

  25. PHIDISA IIMedian CD4+ Cell Count Over Follow-up CD4+ Cell Count (cells/mm3) Follow-up Visit (months) * Screening visit ** Randomization

  26. PHIDISA IIMedian HIV Viral Load Over Follow-up Log10 Viral Load (copies/mL) Follow-up Visit (months) * Screening visit ** Randomization

  27. PHIDISA IIPercent HIV Viral Load < 50 Copies/mL Percent Follow-up Visit (months) * Screening visit ** Randomization

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