PERINATAL CORE PROTOCOL: P1025 IMPAACT Meeting December 45, 2006

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PERINATAL CORE PROTOCOL P1025 IMPAACT
MeetingDecember 4-5, 2006
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PROTOCOL P1025 VERSION 3.0

• Prospective cohort of HIV-infected pregnant women
  and their infants at university affiliated
  clinical sites across the US
• Women can enroll if 14 weeks gestation, within
  14 days of delivery, or identified HIV-infected
  within 14 days of delivery
• Data primarily abstracted from medical records of
  routine clinical care supplemented by patient
  interviews and laboratory assessments
• Women and infants followed to 1-year post-partum
• Target cohort size 1,600 mother/infant pairs

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P1025 GOALS

• To assess the effectiveness and safety of ARV and
  other interventions for pregnant women and their
  infants
• To provide a valuable data base for evaluation of
  emerging issues e.g. drug toxicities, ARV
  resistance
• To provide data to develop and conduct the
  perinatal and maternal health research agendas
• To provide referrals and source data for long
  term follow-up protocols e.g. 219C, PHACS
• To serve as a framework for efficient conduct of
  sub-studies e.g. 1026s
• To provide specimen repository to further define
  the pathophysiology of MTCT

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WOMEN INFANTS ENROLLED AND FOLLOWED AS OF
SEPTEMBER 30, 2006
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DIFFERENCES IN CHARACTERISTICS OF WOMEN ENROLLED
VS. NOT ENROLLED IN P1025
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DIFFERENCES IN CHARACTERISTICS CONTD
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REASONS FOR NON-ENROLLMENT

• Clinic-related reasons included
• Staffing or site resources (26.7 of women)
• Clinician refusal because of the womans
  non-adherence to prenatal care and/or poor
  research candidacy (10.8)
• Patient-related reasons included
• Unavailability of women for enrollment (20.3)
• Refusal because of mistrust (10.1)
• Refusal because of time requirements (8.3)
• Refusal because of distance to the clinic (4.7)
• Spontaneous abortion (4.7)

Brogly S, Read J, Shapiro D, Stek A, Tuomala R.
Participation of HIV-infected pregnant women in
research in the US. AIDS Research Human
Retroviruses, in press
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CHARACTERISTICS OF WOMEN ENROLLED IN P1025
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CHARACTERISTICS CONTD
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ARV REGIMENS USE OF WOMEN BY YEAR
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NRTI USE DURING PREGNANCY
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PI FI USE DURING PREGNANCY
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NNRTI USE DURING PREGNANCY
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ARV USE AT P1025 CONCEPTION

• 220 women on ARV at conception
• 23 missing data
• 777 women not on ARV at conception
• 462 ARV naïve
• 244 1st antenatal CD4 gt350 and RNA lt100,000
• 315 ARV experienced
• 158 1st antenatal CD4 gt350 and RNA lt100,000

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INFANT CHARACTERISTICS (N955)
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INFANT INFECTION STATUS (N955)

• 679 (72.3) uninfected
• 256 (27.3) pending
• 4 (0.5) HIV-infected
• Two women initiated ARV in the last three weeks
  of pregnancy HIV infection identified late
  cesarean sections infants infected in utero
• One woman received no ARV HIV infection
  identified at LD vaginal delivery timing of
  infant infection being queried
• One woman on ARV throughout pregnancy HIV
  infection identified in 1990 1st prenatal visit
  in third trimester viral load at delivery 5,012
  copies/mL cesarean section infant infected in
  utero

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P1025 WORK IN PROCESS

• Adherence to antiretroviral therapy of women
  enrolled in P1025 (presented at CROI 2006,
  manuscript in preparation)
• DACS 618 Participation in research of pregnant
  HIV-infected women in the US (in press, AIDS
  Research Human Retroviruses)
• DACS 622 Hepatic toxicity in HIV-infected
  pregnant and non-pregnant women receiving NVP (in
  collaboration with WITS and WIHS)
• DACS 626 In utero NRTI exposure and
  mitochondrial dysfunction in HIV-uninfected
  infants
• In Development
• Health of infants born to HIV-infected women
• Maternal HIV genotypic resistance
• Safety and antiviral activity of trizivir (in
  collaboration with P1039)

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P1025 TEAM

• Arlene Bardeguez
• Susan Brogly
• Yvonne Bryson
• Sandy Burchett
• Charmane Callilap-Bernardo
• Emily Demske
• Carol Elgie
• Elizabeth Livingston

• Jennifer Read
• Gwen Scott
• Maureen Shannon
• David Shapiro
• Elizabeth Smith
• Alice Stek
• Ruth Tuomala

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ARV REGIMENS BY YEAR
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INITIAL ARV OF WOMEN NOT ON ARV AT CONCEPTION
AND WITH CD4 gt350, AND RNA lt100,000
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INFANT AND FETAL DEATHS
Infant death rate 0.3, Fetal death rate 0.8
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ENROLLMENT AND REFUSAL October 2002 to September
2006