ClinSurv-HIV Dr. Osamah Hamouda, MPH Department for Infectious - - PowerPoint PPT Presentation

• Dr. Osamah Hamouda, MPH

Department for Infectious Disease Epidemiology HIV/AIDS and STI Unit

Clinical Surveillance of HIV-Disease

ClinSurv-HIV

AREVIR-Meeting und Arbeitstreffen des Verbundprojektes „Monitoring von resistenten HIV in Deutschland“ Bonn, 20. April 2007

Primary objectives

• assess the demographic structure of treated HIV patients

and monitor over time

• monitor changes in occurrence of HIV related diseases
• evaluate the different ART regimen and their effects
• utside controlled clinical trials
• ascertain potential risk factors for disease progression

Secondary objectives

• estimate the total number of HIV patients receiving care
• provide a database for future research projects

ClinSurv-HIV - Objectives

ClinSurv-HIV - Study Design

• Prospective multicentre observational study
• Start: 01.01.1999
• Inclusion of all HIV patients irrespective of stage of

disease treated at major HIV treatment centres in Germany

• Local data collection in established databases of the

centres

• No informed consent necessary (limited amount of data)
• Approval obtained by the Federal Data Protection

Commissioner

ClinSurv-HIV – Participating Centres

currently 15 active centres

Berlin Hamburg

Auguste-Viktoria-Klinikum IFI Charité Campus Virchow Universitätsklinikum Eppendorf

Bochum

IPM–Studycenter Ruhr Universität Bochum

Kiel Bonn

Städt. Krankenhaus Kiel Universitätsklinik Bonn

Köln Düsseldorf

Klinik I der Universität Köln Universitätsklinikum Düsseldorf

München Essen

Universitätsklinik München Universitätsklinikum Essen

Regensburg Hannover

Universitätsklinikum Regensburg

• Med. Hochschule Hannover

Rostock

Universitätsklinikum Rostock

ClinSurv-HIV - Study Design

Regional distribution of 15 active centres

• <0,001

0,001

• <0,01

0,01

• <0,1

0,1

• <1

1

• <10

10

• <100

Incidence of newly diagnosed HIV infections per 100.000 pop. in 2006

Berlin 2 Bochum 1 Bonn 1 D'dorf 1 Essen 1 Hamburg 3 Hannover 1 Kiel 1 Köln 1 München 1 Regensburg 1 Rostock 1

ClinSurv-HIV – Methods

General Data Management

• Transfer of anonymous data bi-annually in a

predefined specific format

• Use of an alphanumeric identifier (RKI-Code), to

identify duplicates and supplement data

• Databases of four RKI projects have been combined

into unified HIV/AIDS database – AIDS-case registry (1982) – HIV-Seroconverter Study (1997) – HIV-Documentation Nordrhein (1999) – ClinSurv HIV (1999)

HIV/AIDS Databases at RKI

Dataflow

• Clinics with electronic DB
• Clinics without electronic DB
• Private practice networks (MVZ)
• Other private practices

RKI ClinSurv AIDS- Fall- register HIV-Doku- mentation Nordrhein HIV- Serokon- verter Studie RKI HIV/AIDS Datenbank

ClinSurv-HIV – Methods

Data

• Demographic data

RKI-Code, sex, date of birth (mm/yyyy), PLZ, country of origin, date of first visit

• HIV Infection

Transmission group, date of first positive AB-test

• Clinical data

HIV-associated and AIDS-defining diagnoses,

• Lab data

CD4- und CD8- cell count, viral load

• Antiretroviral Therapy

ART-drugs, start and stop dates, reason for drug/regime change

ClinSurv-HIV – Methods

Data structure for data submission (schematic)

Fully compatible with HICDEP format

ClinSurv-HIV – Methods

Data quality assurance

• Definition of minimal standard for remuneration
• Specific criteria for plausibility and completeness for

all variables

• Inconsistent or incomplete data are not included into

database

• Regular standardised feedback to the centres
• Querry lists and request to correct data within six

weeks

ClinSurv-HIV – Methods

ClinSurv case definition

• Confirmed positive HIV-antibody test
• Information on RKI-code, sex, date of birth

(mm/yyyy), zipcode (3 digits), country of origin and

• At least one documented event in Lab-, Diagnosis-,
• r Medication tables after 01.01.1999

ClinSurv- HIV – Results

Study patients (01.01.1999 bis 30.06.2006)

17,619 cases (60,455 PYF)

6,403 Patients with first visit before 1999

11,216

Patients with first visit since 1999

• 1999

1614

• 2000

1638

• 2001

1487

• 2002

1518

• 2003

1483

• 2004

1548

• 2005

1414

• 2006

504 (up to 30.06.2006)

ClinSurv-HIV – Results

Duplicates (reports from different ClinSurv centres) 17.619 patients 1451 pts. multiples (8,2%)

• f those

1354 duplicates 89 triplicates 5 four-fold 3 five-fold

ClinSurv inclusion criteria (1.1.1999)

ClinSurv-HIV – Results

Study patients: Demographics Total number 17.619 age at FV Male 14.222 (80,7%) 37 yr Female 3.395 (19,3%) 32 yr Origin Germany 12.818 (72,8%) Western Europe 619 ( 3,5%) Central Europe 504 ( 2,9%) Eastern Europe, Asia 475 ( 2,7%) Africa, Middle East 1.542 ( 8,8%) America, Oceania 285 ( 1,6%) Unknown 1.376 ( 7,8%)

ClinSurv-HIV – Results

Transmission group by half year of first visit (n= 17.619)

0% 20% 40% 60% 80% 100%

< 1 9 9 9 1 9 9 9

• 1

1 9 9 9

• 2

2

• 1

2

• 2

2 1

• 1

2 1

• 2

2 2

• 1

2 2

• 2

2 3

• 1

2 3

• 2

2 4

• 1

2 4

• 2

2 5

• 1

2 5

• 2

2 6

• 1

Unkn./NRI MTC HPL

• prob. Hetero

Hetero Hemo/Transf IDU MSM

30 32 34 36 38 40 42 44 1 9 9 9

• 1

1 9 9 9

• 2

2

• 1

2

• 2

2 1

• 1

2 1

• 2

2 2

• 1

2 2

• 2

2 3

• 1

2 3

• 2

2 4

• 1

2 4

• 2

2 5

• 1

2 5

• 2

2 6

• 1

half year of FV Age Men Women

ClinSurv-HIV – Results

Mean age by sex and half year of FV (N=11.216)

ClinSurv-HIV – Results

CD4-cell count/µl by half year of FV (N = 8.126 / 11.216)

0% 20% 40% 60% 80% 100% 1 9 9 9

• 1

2

• 1

2 1

• 1

2 2

• 1

2 3

• 1

2 4

• 1

2 5

• 1

2 6

• 1

half year of first visit

>= 500 350-499 200-349 < 200

(Wert mit kleinstem Abstand im Range -90/+30Tage von Erstvorstellung; MW = 2,75 Tage, Median = 0 Tage)

ClinSurv-HIV – Results

Viral load (N=6958) and CD4 cell count (N=8126) Median at first visit by CDC stage

100 200 300 400 500 600 700 1 9 9 9

• 1

2

• 1

2 1

• 1

2 2

• 1

2 3

• 1

2 4

• 1

2 5

• 1

2 6

• 1

CD4 N/µl

1 2 3 4 5 6

VL log10/ml

CD4 - non B,C CD4 - B CD4 - C VL - non B,C VL - B VL - C

Wert mit kleinstem Abstand im Range -90/+30Tage von Erstvorstellung CD4, MW = 2,75 Tage, Median = 0 Tage; VL, MW = 3,0 Tage, Median = 0 Tage

ClinSurv-HIV – Results

CDC - stage at first visit (N=11.216)

0% 20% 40% 60% 80% 100% 1 9 9 9

• 1

2

• 1

2 1

• 1

2 2

• 1

2 3

• 1

2 4

• 1

2 5

• 1

2 6

• 1

half year of first visit

C B non BC unk.

neu aufgenommene Patienten seit dem 01.01.1999, Erkrankungen bis Erstvorstellung + 30 Tage

ClinSurv-HIV – Results

Incidence rates of AIDS-defining diagnoses/100 PYF

2 4 6 8 10 12 14 16 18 20 1 9 9 9

• 1

1 9 9 9

• 2

2

• 1

2

• 2

2 1

• 1

2 1

• 2

2 2

• 1

2 2

• 2

2 3

• 1

2 3

• 2

2 4

• 1

2 4

• 2

2 5

• 1

2 5

• 2

2 6

• 1

Half year of follow up Diagnoses/100 PYF Cervix-Ca HIV-Enc. Wasting NHL KS OI

Acknowledgements

RKI HIV/AIDS and STI Unit

Christian Kollan Andrea Kühne

ClinSurv Steering group

• Prof. Dr. Brockmeyer
• Prof. Dr. Rockstroh
• Prof. Dr. Bogner
• Prof. Dr. Stoll

funded by

• BMG 1999; since 2000 RKI bundget
• BMBF, KompetenzNetz HIV/AIDS 2003 - 2005