Transcript Highlights of MACS and WIHS Protocol and Cohorts Lisa Jacobson Stephen Gange May 25, 2005 Not for distribution or publication outside the Multicenter AIDS Cohort Study or Women’s.

Highlights of
MACS and WIHS
Protocol and Cohorts
Lisa Jacobson
Stephen Gange
May 25, 2005
Not for distribution or publication outside the
Multicenter AIDS Cohort Study or
Women’s Interagency HIV Study
MACS
Principal Investigators and Sites
Roger Detels,
Los Angeles
Charles Rinaldo,
Pittsburgh
Lisa Jacobson,
CAMACS
Joe Margolick,
Baltimore
John Phair,
Chicago
November 2004
WIHS
Principal Investigators and Sites
Kathryn Anastos,
Bronx
Alexandria Levine,
Los Angeles
Mardge Cohen,
Chicago
Stephen Gange,
WDMAC
Ruth Greenblatt,
San Francisco
Howard Minkoff,
Brooklyn
Mary Young,
District of Columbia
November 2004
MACS
WIHS
http://www.statepi.jhsph.edu/macs/
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
Working Groups
php/dir_main.php
Forms
forms.html
May 2005
http://www.statepi.jhsph.edu/php/
wihsdir/search.php
admin/index.visitforms-moo.html
Password protected
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
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
MACS / WIHS Cohort: Summary
MACS
WIHS
Prospective cohort
Prospective cohort
Semi-annual
Semi-annual
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
Medically confirmed
Medically confirmed
6,973
3,768
• Study design
• Follow-up visits
• Data collection sites
• Outcome ascertainment
(active and passive)
• Total enrolled
May 2005
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
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
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
MACS/WIHS Database
MACS
WIHS
HIV+
HIV-
HIV+
HIV-
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
27,992
--
Total Participants
Repository aliquots*
*Available as of 5/9/2005
1,147
842,231
1,495,589
May 2005
Demographics of
MACS/WIHS Cohorts: Baseline
MACS
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
% < high school
2
16
5
37
38
38
% > college
56
31
51
7
8
7
Median age
(IQR)
33
38
34
(28; 38) (32; 43) (29; 39)
36
31
34
(30; 41) (26; 37) (29; 40)
November 2004
HIV Disease Markers at Most Recent Visit:
Current MACS/WIHS Cohorts
Overall MACS
Overall WIHS
(n=1316)
(n=1652)
488
(332; 673)
418
(266; 624)
Med
(IQR)
889
(644; 1,185)
785
(554; 1,078)
HIV RNA
Med
(IQR)
65
(<50; 9,242)
475
(<80; 12,000)
CD4 (cells/l)
Med
(IQR)
CD8 (cells/l)
November 2004
Antiretroviral Therapy Use Among Seropositives
NRTI Monotherapy
NRTI Combination Therapy
HAART with PI
HAART no PI
100
MACS
WIHS
1995 1997 1999 2001 2003
1995 1997 1999 2001 2003
80
60
40
20
0
Calendar Time
May 2005
Age Distribution among Active
HIV+ MACS & WIHS Participants
MACS
WIHS
400
350
300
250
200
150
100
50
0
<30
30-35
35-40
40-45
45-50
Age Distribution
50-55
55-65
>65
May 2005
Age Distribution among Active
HIV- MACS & WIHS Participants
MACS
WIHS
400
350
300
250
200
150
100
50
0
<30
30-35
35-40
40-45
45-50
Age Distribution
50-55
55-65
>65
May 2005
HAART Use in the MACS/WIHS Cohorts
Incidence of HAART per 100 P-SEM
100
MACS Cumulative Incidence
WIHS Cumulative Incidence
MACS Incidence Rate
WIHS Incidence Rate
80
60
40
20
0
96-1
97-1
98-1
99-1
00-1
01-1
Calendar (Year-Semester)
02-1
03-1
04-1
May 2005