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

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Presentation 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 Interagency HIV Study

MACS Principal Investigators and Sites November 2004 Lisa Jacobson, CAMACS John Phair, Chicago Charles Rinaldo, Pittsburgh Roger Detels, Los Angeles Joe Margolick, Baltimore

WIHS Principal Investigators and Sites Alexandria Levine, Los Angeles Mary Young, District of Columbia Stephen Gange, WDMAC Ruth Greenblatt, San Francisco Mardge Cohen, Chicago Kathryn Anastos, Bronx Howard Minkoff, Brooklyn November 2004

Password protected MACS WIHS Homemacs.htmlindex.html Dossierdossier/MACS_Dossier.pdfwihsdossier/dossier.ppt Archivesarchives.html Concept Formforms.htmlwihsconceptsheetsubform.doc Public Data Tapepdt.htmlPublicData/index.html Publication Policypubpolicy.html Directoryphp/dir_main.php wihsdir/search.php Working Groupsphp/dir_main.php Formsforms.htmladmin/index.visitforms-moo.html May 2005

► 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 MACS Working Groups - Chairs 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 MACSWIHS Study designProspective cohort Follow-up visitsSemi-annual Data collection sitesBaltimore/DC, Chicago, Los Angeles, Pittsburgh Bronx, Brooklyn, Chicago, DC, Los Angeles, San Francisco Data centerJohns Hopkins Univ. Date started Current visit (4/05 – 9/05) 4322 Outcome ascertainment (active and passive) Medically confirmed Total enrolled6,9733,768 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

MACSWIHS Total enrolled6,9733,768 Seropositives - Prevalent - Incident 3,501 2, ,809 2, AIDS cases - Prevalent - Incident 1, ,832 1, Number of deaths1, Number of HAART users since 1/951,3271,891 Alive & active since 4/032,7542,416 - HIV+, AIDS (HAART) - HIV+, AIDS-free (HAART) - HIV- 176 (174) 1,096 (893) 1, (589) 1,071 (858) 690 Descriptive Statistics May 2005

MACSWIHS HIV+HIV-HIV+HIV- Total Participants3,5013,4722, Person-years27,92540,50214,9324,545 Person-visits44,82259,91129,5719,085 CD4 measurements41,83246,29528,1036,436 HIV RNA measurements23,2551,14727, Repository aliquots*842,2311,495,589 MACS/WIHS Database May 2005 *Available as of 5/9/2005

MACSWIHS Pre OverallPre Overall % Seropositive % Non-white % < high school % > college Median age (IQR) 33 (28; 38) 38 (32; 43) 34 (29; 39) 36 (30; 41) 31 (26; 37) 34 (29; 40) Demographics of MACS/WIHS Cohorts: Baseline November 2004

Overall MACS (n=1316) Overall WIHS (n=1652) CD4 (cells/  l) Med (IQR) 488 (332; 673) 418 (266; 624) CD8 (cells/  l) Med (IQR) 889 (644; 1,185) 785 (554; 1,078) HIV RNA Med (IQR) 65 (<50; 9,242) 475 (<80; 12,000) HIV Disease Markers at Most Recent Visit: Current MACS/WIHS Cohorts November 2004

Antiretroviral Therapy Use Among Seropositives Calendar Time May 2005 NRTI MonotherapyNRTI Combination Therapy HAART no PI HAART with PI MACS WIHS

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 May Calendar (Year-Semester) Incidence of HAART per 100 P-SEM MACS Incidence RateMACS Cumulative Incidence WIHS Incidence RateWIHS Cumulative Incidence