Multicenter AIDS Cohort Study Dossier May 2006

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Multicenter AIDS Cohort StudyDossierMay 2006

• Prepared by CAMACS
• Fax [phone]
• Web site http//statepi.jhsph.edu/macs/macs.html

May 2006
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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
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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
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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
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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
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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
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Administrative Forms

• Data Set Transmission
• Study Investigator Registration for using MACS
  Specimens
• Restricted Use of MACS Specimens

May 2000
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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
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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
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(No Transcript)
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Composition Size of Cohort
Participants (thousands)
Visit (Calendar year)
1665 (95 of 1758) have been administratively
censored
May 2006
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Total of CD4 and HIV RNAMeasurements by
Serostatus
May 2006
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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
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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
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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
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Likelihood of Developing AIDS in Three Years
Mellors, Muñoz, . . ., Rinaldo - Ann Int Med
1997
June 1997
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Use of Antiretroviral Therapy by Seropositive
MACS Participants without Clinical AIDS
Detels, Tarwater, . . ., Muñoz - AIDS 2001
(update)
Receiving Therapy
Calendar Year
May 2006
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Use of Antiretroviral Therapy by Seropositive
MACS Participants with Clinical AIDS
Detels, Tarwater, . . ., Muñoz - AIDS 2001
(update)

Receiving Therapy
Calendar Year
May 2006
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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
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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

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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
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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
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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
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Key Factors in the Success of the MACS

• The commitment and sacrifice of the participants
• The staff members of the MACS
• Strong laboratory support

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UCLA MACS Staff

• John Oishi, Study Coordinator
• Max Hechter
• Julie Saulny
• Kevin Barrett

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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

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MACS Laboratory Investigators

• Beth Jamieson
• John Fahey
• Anthony Butch
• Steve Young
• Najib Aziz
• Oto Martinez
• Rita Effros