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Multicenter AIDS Cohort Study Dossier May 2006

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Title: Multicenter AIDS Cohort Study Dossier May 2006


1
Multicenter AIDS Cohort StudyDossierMay 2006
  • Prepared by CAMACS
  • Fax 410-955-7587
  • Web site http//statepi.jhsph.edu/macs/macs.html

May 2006
2
MACS Sites andPrincipal Investigators
  • Sites
  • Baltimore, MD (J. Margolick)
  • Chicago, IL (J. Phair)
  • Los Angeles, CA (R. Detels, B. Visscher)
  • Pittsburgh (C. Rinaldo, L. Kingsley)
  • Data Coordinating Center (CAMACS)
  • Baltimore, MD (L. Jacobson, A. Muñoz)

November 2004
3
MACS Working Groups
  • Behavioral (D. Ostrow)
  • Clinical (F. Palella)
  • Core Laboratory (C. Rinaldo J. Margolick)
  • Data (L. Jacobson)
  • Immunology/Virology (J. Margolick)
  • Malignancy/Pathology (O. Martinez-Maza)
  • Metabolic/Cardiovascular (L. Kingsley)
  • Neuropsychology (E. Miller)
  • Renal (F. Palella)
  • Viral Hepatitis (C. Thio)

May 2006
4
Semiannual Visit
  • Medications
  • Antiretrovirals, OI-specific, Adherence
  • Physical Examination / Lipodystrophy / Frailty
  • Specimens and Labs
  • Plasma, Serum, Cells
  • B-cell lines
  • PBMC pellets
  • T-cells, HIV RNA, HBV HCV serology
  • Lipids, liver and kidney function tests
  • Questionnaire / ACASI
  • Medical History, Health Services, Behavior
  • Demographics / Psychosocial
  • Quality of Life
  • Neuropsychological Screening

May 2006
5
Continuous Outcome Ascertainment
  • Seroconversion
  • Clinical Outcomes (medical records confirmation)
  • AIDS diagnoses
  • Non-AIDS diagnoses
  • Cardiovascular disease
  • Cerebrovascular disease
  • Kidney disease
  • Liver disease
  • Lung infection, bacterima, septicemia
  • Malignancies
  • Neurologic
  • Mortality

November 2004
6
Data Collection Forms
  • Drug Form 1 (anti-virals) 2 (non-antivirals)
  • Antiretroviral Medication Adherence
  • Section 2 (demographics, psychosocial)
  • Physical Exam / Lipodystrophy Exam
  • Section 4 (behavior, medical history, health
    services)
  • Quality of Life
  • Neuropsychological
  • PWA
  • Seroconversion
  • Clinical Outcomes

Administered using Audio Computer Assisted
Structured Interview (ACASI)
October 2002
7
Administrative Forms
  • Data Set Transmission
  • Study Investigator Registration for using MACS
    Specimens
  • Restricted Use of MACS Specimens

May 2000
8
CAMACS
  • Planning and design of studies
  • Coordination of data acquisition
  • Form development
  • Codebooks
  • Data transfer
  • Standardization and data management
  • Edits and updates
  • Data security
  • Data analysis, statistical computing and
    methodological research

September 1995
9
MACS Database
Publications
1,000 Participants 6,973 Person-Years
71,530 Variables 7,545 Repository
aliquots 903,247 (plasma, serum, cells)
HIV HIV- Person-Visits 46,409
62,001 CD4 Measurements 44,341 48,252 HIV
RNA Measurements 26,073 926
10
(No Transcript)
11
Composition Size of Cohort
Participants (thousands)
Visit (Calendar year)
1665 (95 of 1758) have been administratively
censored
May 2006
12
Total of CD4 and HIV RNAMeasurements by
Serostatus
May 2006
13
Incidence of Seroconversion in the MACS by Center
Kingsley, Zhou, . . ., Muñoz - AJE 1991
(update)
Baltimore Chicago Pittsburgh Los Angeles
Incidence of seroconverters per 1,000
person-semesters
September 1995
14
Progression of HIV-1 InfectionPrior to Potent
Antiretroviral Therapy
Muñoz, Xu. Stat Med 1996 Enger et al. JAMA
1996 Jacobson et al. AJE 1993 (update)
Proportion
October 1998
15
Proportion Surviving AIDS by Year of
DiagnosisAssumed currently alive at 6/30/99 if
contacted since 6/30/98
Jacobson, Kirby, . . ., Schrager - AJE 1993
(update)
October 1999
16
Likelihood of Developing AIDS in Three Years
Mellors, Muñoz, . . ., Rinaldo - Ann Int Med
1997
June 1997
17
Use of Antiretroviral Therapy by Seropositive
MACS Participants without Clinical AIDS
Detels, Tarwater, . . ., Muñoz - AIDS 2001
(update)
Receiving Therapy
Calendar Year
May 2006
18
Use of Antiretroviral Therapy by Seropositive
MACS Participants with Clinical AIDS
Detels, Tarwater, . . ., Muñoz - AIDS 2001
(update)

Receiving Therapy
Calendar Year
May 2006
19
Use of Antiretroviral Therapy and Effectiveness
at the Population Level
Tarwater, Mellors, . . ., Muñoz - AJE
2001 Detels, Muñoz, . . ., Phair - JAMA 1998
(update)
100
Relative Hazard of AIDS at equal infection
duration
1.52
1
0.91
0.30
Relative Hazard of AIDS at equal CD4 cell count
and HIV RNA
80
1.52
1
1.03
0.31
60
Receiving Therapy
40
20
0
1987
1988
1989
1990
1991
1992
1993
1994
1995
1996
1997
1998
1999

May 2001
20
MACS Subgroups of Particular Interest
  • Long-term seropositive individuals with minimal
    declines in CD4 levels
  • Seropositive individuals with rapid declines in
    CD4 levels
  • Long-term survivors with low CD4 levels
  • Seroconverters
  • High-risk seronegatives

21
Number of Participants withSpecimens Available
in the National RepositoryRelative to the Time
of Seroconversion
2 or more tubes A total of 602 participants
have a known seroconversion date
May 2006
22
Number of Participants withSpecimens Available
in the National RepositoryRelative to the
Development of AIDS
2 or more tubes A total of 1864 participants
have developed AIDS
May 2006
23
Number of Participants withSpecimens Available
in the National RepositoryRelative to HAART Use
2 or more tubes A total of 1353
participants have initiated HAART
May 2006
24
Key Factors in the Success of the MACS
  • The commitment and sacrifice of the participants
  • The staff members of the MACS
  • Strong laboratory support

25
UCLA MACS Staff
  • John Oishi, Study Coordinator
  • Max Hechter
  • Julie Saulny
  • Kevin Barrett

26
MACS Staff
  • Dennis Miles, LA Mens Study Site Manager
  • May Htike, Staff Physician
  • Daniel Cheng
  • Eric Abril, Examiner
  • Alan Ernst, Interviewer
  • Los Angeles Gay Lesbian Center
  • Eduardo Mercado, Coordinator
  • Ray Mercado, Assistant Coordinator
  • Harbor General
  • Carlos Aquino, Coordinator
  • Carlos Ramoz, Assistant coordinator

27
MACS Laboratory Investigators
  • Beth Jamieson
  • John Fahey
  • Anthony Butch
  • Steve Young
  • Najib Aziz
  • Oto Martinez
  • Rita Effros
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