Title: Multicenter AIDS Cohort Study Dossier May 2006
1Multicenter AIDS Cohort StudyDossierMay 2006
- Prepared by CAMACS
- Fax 410-955-7587
- Web site http//statepi.jhsph.edu/macs/macs.html
May 2006
2MACS 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
3MACS 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
4Semiannual 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
5Continuous 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
6Data 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
7Administrative Forms
- Data Set Transmission
- Study Investigator Registration for using MACS
Specimens - Restricted Use of MACS Specimens
May 2000
8CAMACS
- 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
9MACS 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)
11Composition Size of Cohort
Participants (thousands)
Visit (Calendar year)
1665 (95 of 1758) have been administratively
censored
May 2006
12Total of CD4 and HIV RNAMeasurements by
Serostatus
May 2006
13Incidence 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
14Progression 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
15Proportion 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
16Likelihood of Developing AIDS in Three Years
Mellors, Muñoz, . . ., Rinaldo - Ann Int Med
1997
June 1997
17Use of Antiretroviral Therapy by Seropositive
MACS Participants without Clinical AIDS
Detels, Tarwater, . . ., Muñoz - AIDS 2001
(update)
Receiving Therapy
Calendar Year
May 2006
18Use of Antiretroviral Therapy by Seropositive
MACS Participants with Clinical AIDS
Detels, Tarwater, . . ., Muñoz - AIDS 2001
(update)
Receiving Therapy
Calendar Year
May 2006
19Use 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
20MACS 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
21Number 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
22Number 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
23Number 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
24Key Factors in the Success of the MACS
- The commitment and sacrifice of the participants
- The staff members of the MACS
- Strong laboratory support
25UCLA MACS Staff
- John Oishi, Study Coordinator
- Max Hechter
- Julie Saulny
- Kevin Barrett
26MACS 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
27MACS Laboratory Investigators
- Beth Jamieson
- John Fahey
- Anthony Butch
- Steve Young
- Najib Aziz
- Oto Martinez
- Rita Effros