Highlights of MACS and WIHS Protocol and Cohorts

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Highlights of MACS and WIHSProtocol and Cohorts

• Lisa Jacobson
• Stephen Gange
• May 25, 2005
• Not for distribution or publication outside the
• Multicenter AIDS Cohort Study or
• Womens Interagency HIV Study

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MACSPrincipal Investigators and Sites
Roger Detels, Los Angeles
Charles Rinaldo, Pittsburgh
November 2004
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WIHSPrincipal Investigators and Sites
Kathryn Anastos, Bronx
Alexandria Levine, Los Angeles
Mardge Cohen, Chicago
Howard Minkoff, Brooklyn
Stephen Gange, WDMAC
Mary Young, District of Columbia
Ruth Greenblatt, San Francisco
November 2004
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MACS http//www.statepi.jhsph.edu/macs/ WIHS http//statepiaps.jhsph.edu/wihs/
Home macs.html index.html
Dossier dossier/MACS_Dossier.pdf wihsdossier/dossier.ppt
Archives archives.html archives.html
Concept Form forms.html wihsconceptsheetsubform.doc
Public Data Tape pdt.html PublicData/index.html
Publication Policy pubpolicy.html
Directory php/dir_main.php http//www.statepi.jhsph.edu/php/ wihsdir/search.php
Working Groups php/dir_main.php
Forms forms.html admin/index.visitforms-moo.html
Password protected
May 2005
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MACS Working Groups - Chairs

• Behavioral - D. Ostrow
• Clinical - F. Palella
• Core Laboratory - C. Rinaldo J. Margolick
• Data - L. Jacobson
• Malignancy/Pathology - O. Martinez-Maza
• Metabolic/Cardiovascular - L. Kingsley
• Neuropsychology - E. Miller
• Viral Hepatitis - C. Thio

November 2004
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WIHS Scientific Working Groups - Chairs

• Aging/Neurocognitive M. Young
• Behavior/Drug Use T. Wilson / D. Vlahov
• Cancer/Pathology N. Hessol
• Cardiovascular R. Kaplan
• Epidemiology A. French
• GYN H. Minkoff
• Hepatitis M. Peters
• HIV Virology - B. Weiser
• HPV H. Strickler
• Immunology - L. Al-Harthi
• Laboratory/Specimen W. Meyer
• Metabolic P. Tien
• Pharmacology - R. Greenblatt
• Statistical/Analytical A. Kalinowski

May 2005
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MACS / WIHS Cohort Summary
MACS WIHS
Study design Prospective cohort Prospective cohort
Follow-up visits Semi-annual Semi-annual
Data collection sites Baltimore/DC, Chicago, Los Angeles, Pittsburgh Bronx, Brooklyn, Chicago, DC, Los Angeles, San Francisco
Data center Johns Hopkins Univ. Johns Hopkins Univ.
Date started 1984 1994
Current visit (4/05 9/05) 43 22
Outcome ascertainment (active and passive) Medically confirmed Medically confirmed
Total enrolled 6,973 3,768
May 2005
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Semiannual Visit

• Medications
• Antivirals, OI-specific, adherence
• Physical Examination / GYN (WIHS)
• Anthropomorphic/ lipodystrophy measures
• Hand grip / timed walk (MACS v43.5 WIHS v22)
• Questionnaire / ACASI (MACS)
• Medical History, Health Services, Behavior
• Demographics / Psychosocial
• Quality of Life
• Neuropsychological Screening
• Specimens and Labs
• Plasma, Serum, Cells, CVL (WIHS), Hair (WIHS
  HIV)
• T-cells, HIV RNA, HBV HCV serology, lipids
• B-cell lines, National Repository

May 2005
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Continuous Outcome Ascertainment

• Seroconversion
• Clinical Outcomes (medical record confirmation)
• AIDS diagnoses
• Non-AIDS diagnoses
• Cardiovascular disease
• Cerebrovascular disease
• Kidney disease (MACS)
• Liver disease
• Lung infection, bacterima, septicemia (MACS), TB
  (WIHS)
• Malignancies
• Neurologic
• Mortality and cause of death

November 2004
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Descriptive Statistics
MACS WIHS
Total enrolled 6,973 3,768
Seropositives - Prevalent - Incident 3,501 2,884 617 2,809 2,793 16
AIDS cases - Prevalent - Incident 1,843 11 1,832 1,364 715 649
Number of deaths 1,897 712
Number of HAART users since 1/95 1,327 1,891
Alive active since 4/03 2,754 2,416
- HIV, AIDS (HAART) - HIV, AIDS-free (HAART) - HIV- 176 (174) 1,096 (893) 1,482 655 (589) 1,071 (858) 690
May 2005
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MACS/WIHS Database
MACS MACS WIHS WIHS
HIV HIV- HIV HIV-
Total Participants 3,501 3,472 2,809 959
Person-years 27,925 40,502 14,932 4,545
Person-visits 44,822 59,911 29,571 9,085
CD4 measurements 41,832 46,295 28,103 6,436
HIV RNA measurements 23,255 1,147 27,992 --
Repository aliquots 842,231 842,231 1,495,589 1,495,589
Available as of 5/9/2005
May 2005
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Demographics of MACS/WIHS Cohorts Baseline
MACS MACS MACS WIHS WIHS WIHS
Pre-2001 2001-3 Overall Pre-2001 2001-2 Overall
Seropositive 40 53 42 78 65 74
Non-white 17 72 28 82 91 85
lt high school 2 16 5 37 38 38
gt college 56 31 51 7 8 7
Median age (IQR) 33 (28 38) 38 (32 43) 34 (29 39) 36 (30 41) 31 (26 37) 34 (29 40)
November 2004
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HIV Disease Markers at Most Recent VisitCurrent
MACS/WIHS Cohorts
Overall MACS (n1316) Overall WIHS (n1652)
CD4 (cells/?l) CD4 (cells/?l) CD4 (cells/?l)
Med (IQR) 488 (332 673) 418 (266 624)
CD8 (cells/?l) CD8 (cells/?l) CD8 (cells/?l)
Med (IQR) 889 (644 1,185) 785 (554 1,078)
HIV RNA HIV RNA HIV RNA
Med (IQR) 65 (lt50 9,242) 475 (lt80 12,000)
November 2004
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Antiretroviral Therapy Use Among Seropositives
NRTI Monotherapy
NRTI Combination Therapy
HAART no PI
HAART with PI
100
MACS
WIHS
80
60
40
20
0
1995
1997
1999
2001
2003
1995
1997
1999
2001
2003
Calendar Time
May 2005
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Age Distribution among Active HIV MACS WIHS
Participants
May 2005
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Age Distribution among Active HIV- MACS WIHS
Participants
May 2005
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HAART Use in the MACS/WIHS Cohorts
MACS Incidence Rate
MACS Cumulative Incidence
100
WIHS Incidence Rate
WIHS Cumulative Incidence
80
60
Incidence of HAART per 100 P-SEM
40
20
0
96-1
97-1
98-1
99-1
00-1
01-1
02-1
03-1
04-1
Calendar (Year-Semester)
May 2005