Highlights of MACS and WIHS Protocol and Cohorts

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 Concept Form forms. html wihsconceptsheetsubform. doc Public Data Tape pdt. html Public. Data/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 Semi-annual Baltimore/DC, Chicago, Los Angeles, Pittsburgh Bronx, Brooklyn, Chicago, DC, Los Angeles, San Francisco • Data center Johns Hopkins Univ. • Date started 1984 1994 • Current visit (4/05 – 9/05) 43 22 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 v 43. 5; WIHS v 22) ► 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- 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 CD 4 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 -3 Overall Pre-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) CD 4 (cells/ l) Med (IQR) CD 8 (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 80 60 40 20 0 Calendar Time May 2005

Age Distribution among Active HIV+ MACS & WIHS Participants May 2005

Age Distribution among Active HIV- MACS & WIHS Participants 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