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Collaborations

» Euro-Sida
» I.CO.N.A.
» D.A.D.
» HIV & Cancer
» A.R.T.
» CASCADE
» Other

EURO-SIDA

Coordinator: Jens D. Lundgren, Hvidovre Hospital, Copenhagen, Denmark.

EuroSIDA is a prospective observational cohort study of more than 9'700 patients followed in 72 hospitals in 26 European Countries. The main objective of the study is to assess the impact of antiretroviral drugs on the outcome of the general population of HIV-infected patients living in Europe.

The study has enrolled five cohorts of adult patients (cohort I identified in summer of 1994 (n=3.118); cohort II in winter 1995/96 (n=1.367); cohort III in spring of 1997 (n=2.844); cohort IV in spring of 1999 (n=1.227); cohort V in fall of 2001 (n=1.220)). The patients included in the five cohorts are a random selected from all the patients followed in the various clinics. Until now, a total of 32'870 person-years of patient experience have been collected.

Currently, four SHCS centers are participating: Zürich (151 patients); Geneva (140 patients); Lausanne (144 patients); Bern (50 patients). The collaboration is facilitated by the fact that the information gathered for EuroSIDA is very similar to the anonymous data collection of the ongoing Swiss HIV Cohort Study.

A large number of papers has been published or accepted for publication in peer-reviewed journals (http://www.cphiv.dk/EuroSIDA/Publications/2011/tabid/513/Default.aspx). In a number of these publications, investigators of the SHCS are principal authors or co-authors. Both, EuroSIDA and the SHCS are  participating in several other collaborations (DAD, Cascade, ART Cohort Collaboration, PLATO and the "Collaborative Analysis on the Impact of Lamivudine and Tenofovir Use HBV/HIV Co-Infection". Special precautions have to been taken to avoid overlap in the analysis.

I.CO.N.A (Collaboration Analysis on the Impact of Lamivudine and Tenofovir Use HBV/HIV Co-Infection)

Coordinator: Massimo Puoti, I.CO.N.A Study Group, Milan, Italy.

At the time of this writing (Sept. 2003), this collaboration is still in the developing phase with different cohorts considering participating. The work of data-extraction and analysis will start in summer 2003 should estimated numbers of contributed patients and years of follow-up look promising.

The primary objectives of this collaboration will be to compare patients with HIV/HBV co infection starting regimens of HAART including or not including lamivudine and/or tenofovir in terms of time to liver disease related death. Secondary objectives will be to compare, where available, i) trends of liver function tests, ii) time to hospitalizations and hospitalizations due to liver diseases, and iii) time to occurrence of hepatic decompensation (diagnosis of decompensated cirrhosis).

A preliminary check of the SHCS database resulted in 335 patients with a total of 2100 years of follow-up.

D.A.D. study (Data collection on Adverse events of Anti-HIV Drugs)

Coordinator: Jens D. Lundgren, Hvidovre Hospital, Copenhagen, Denmark.

The experience has shown that some patients under treatment with anti-retroviral drugs increase their blood lipid levels, have their body fat redistributed or their glucose tolerance reduced. These metabolic changes are known to increase the risk of atherosclerosis. The DAD project has as a major hypothesis that the risk of cardiovascular disease might be increased in patients under anti-retroviral treatment.

The DAD Study, initiated in 1999, is a prospective multi-cohort study of HIV-infected persons under active follow up. The purpose of the study is to assess the incidence of myocardial infarction among HIV/AIDS patients who are receiving anti-retroviral therapy. This, in turn, will allow investigating whether treatment with anti-retroviral drugs is associated with development of cardio-vascular disease, an evaluation of long-term side effects.

A total of at least 100 incident cases of myocardial infarction (or other "rare" adverse events, respectively) are required to give sufficient power to detect a two-fold increase in risk. Based on preliminary data from the EuroSIDA study, the incidence of myocaridal infarction among HIV-1 infected persons was assumed to be 3.3 per 1'000 person-years, and hence a study has to collect al least 30'000 person-years of follow-up before the primary objective can be examined. Such an observation period can only be obtained by collaboration of many large cohort studies.

11 cohorts worldwide are participating in DAD, with a total current enrolment of 23,468 patients who have, so far, contributed more than 36,000 person-years of follow-up. The SHCS contributed, so far, 6'059 person-years of follow-up, which is 16.7% of DAD. The study is projected to continue at least until 2005, and provide almost 90,000 person-years of data. The increased number of follow-up years will allow analyzing the impact of individual drug regimens on the risk for cardiovascular disease.

The data collection for DAD takes place at least every 8 months. Each cohort gathers and computerizes its data; subsequently it is merged in a database in Copenhagen. The core data in the study is information on incident cases of cardiovascular disease, which are reported immediately to the local cohort coordinating office by fax, using the event reporting forms. The data collection also includes information on risk factors for cardiovascular disease, such as previous myocardial infarction or stroke, hereditary tendency, smoking status, diabetes mellitus, dyslipidemia and hypertension.

"The Oversight Committee for The Evaluation of Metabolic Complications of HAART" gives support for the study, and a number of pharmaceutical companies producing anti-retroviral drugs contribute financially. The study is supervised by a Steering Committee with representation from each cohort, EMEA, patient community and industry.

The Cohorts involved are the following : ATHENA (AIDS Therapy Evaluation Project Netherlands), Aquitaine (France), AHOD (Australian HIV Observational Database, Australia), BASS (Spain), The Brussels St Pierre Cohort (Belgium), CPCRA (Community Programs for Clinical Research on AIDS, USA), EuroSIDA Study Group (Multinational), HivBivus (Sweden), ICONA (Italy), Nice Cohort (France), SHCS (The Swiss HIV Cohort Study, Switzerland). The list of publications is on www.cphiv.dk

HIV & CANCER

Coordinator : Dr. Silvia Franceschi, International Agency for Research on Cancer (IARC), Lyon, France

In the proposed study, individuals will be matched across the SHCS centers and corresponding Cancer registries to identify all cancers occurring in SHCS participants living in the covered regions of Switzerland. A specifically developed software is used to match individuals and ensures confidentiality.

Cancers of primary interest will include AIDS-defining cancers Kaposi's sarcoma, non-Hodgkin's lymphoma and invasive cervical cancer, as well as non-AIDS-defining cancers Hodgkin's Disease, hepatocellular carcinoma, skin, and other anogenital cancers. Cancers identified through linkage will be classified by the International Classification of Disease for Oncology and incidence rates will be estimated. Sex-, age- and period-standardized rations of observed-to-expected cancers will be used to measure excess cancer risk for HIV infected persons in comparison to the general population.

ART (AntiRetroviral Therapy Cohort Collaboration)

Coordinator: Matthias Egger, Department of Social & Preventive Medicine, University of Bern, Switzerland

The ART Cohort Collaboration is a collaboration between the investigators of currently 13 cohort studies from Europe and North America, which was established in 2001 to estimate the prognosis of treatment-naïve HIV-infected patients initiating highly active antiretroviral therapy (HAART).

The widespread use since 1996 of HAART has substantially improved the prognosis of HIV-infected patients. However, accurate estimates of the probability of clinical progression over several years according to different levels of immunodeficiency, viral replication and other prognostic factors are not available. Information on prognosis is of obvious importance to patients and is also required to gain a better understanding of the treated history of HIV infection, to develop treatment guidelines, monitor and predict the progress of the HIV/AIDS epidemic, and to plan health services in the era of HAART. The objectives of ART are :

• To monitor long-term prognosis in drug-naïve patients initiating HAART
• To develop appropriate prognostic models
• To examine whether progression rates will converge in patients starting HAART at different levels of CD4 cell count
• To investigate the prognostic significance of biomarkers such as liver enzymes and haemoglobin
• To examine cause-specific mortality patterns

The first report from this collaboration was based on 12,574 patients 1,094 of whom developed AIDS or died. (Egger M. Lancet 2002). Prognosis up to three years after starting HAART could be defined for 80 risk strata based on CD4 cell count, viral load, clinical stage, age and transmission category. More recently, a further analysis looked at the prognostic importance of the initial response to HAART (Chêne G, Lancet 2003). With 1268 patients (10%), the SHCS made an important contribution to the collaborative data set – it contributed the third largest number of patients after the French Hospital Database on HIV and the Italian ICONA cohort.

The database of the 13 cohorts is currently being updated which will result in a combined cohort of over 20,000 patients. Furthermore, cohorts from less developed countries in Africa, Asia and Latin America will be joining the collaboration in the months to come.

The ART Cohort Collaboration is supported by a grant from the UK Medical Research Council and GlaxoSmithKline. Funding for the extension to less developed countries has been granted by the French Agence National de Rechreches sur le SIDA (ANRS) and the US National Institutes of Health (NIH).

CASCADE (Concerted Action on Seroconversion to AIDS and Death in Europe)

Coordinator: Kholoud Porter, MRC Clinical Trials Unit, London, UK

CASCADE is a collaboration between the investigators of 22 cohorts in 10 European countries, Australia and Canada, which was set up in 1997.

Only data on persons with a known date of HIV seroconversion (seroconverters) are eligible for inclusion. The date of seroconversion is estimated by various means, typically as the mid-point between the negative and positive HIV antibody test dates for persons with a maximum interval of 3 years between these dates. The study's main aim is to examine and describe the changes in the clinical course of HIV infection in individuals who are treated as well as changes in the natural history of those who are untreated. The objectives of CASCADE are :

• To describe temporal changes in the time to AIDS and of overall survival;
• To investigate the trends in CD4 cell count and plasma viral burden from the time of HIV infection during the whole infection period;
• To examine factors which determine disease progression from the time of infection to the development of AIDS, and changes in the spectrum of AIDS-defining events over time;
• To monitor disease progression both in persons treated and those untreated at the time of primary infection;
• To monitor the time of initiation of therapy and prophylaxis for opportunistic infections in relation to the time since HIV infection.

Seroconverters are enrolled into the individual cohorts locally and nationally and are typically followed up life-long. Data collected on demographic characteristics and on anti-HIV therapies prescribed, laboratory measurements undertaken and clinical status are then standardised and pooled. The collaboration has made major contributions, for example by defining the incubation time of AIDS and survival before the widespread use of potent antiretroviral therapy (Collaborative group on AIDS incubation, Lancet 2000), and the determinants of survival following HIV seroconversion after the introduction of HAART (CASCADE collaboration, Lancet 2003). The list of publications is available
http://www.ctu.mrc.ac.uk/cascade/publications_and_presentations.asp. The SCHS contributed 591 patients (7%) to the collaborative data set.

Future analyses will examine the long-term effects and toxicities of therapy used to reduce the risk of disease progression in acute HIV infection, measure the impact on long-term outcomes of persons infected with drug resistant HIV, assess the long-term impact of HCV and HBV and their treatments on the long-term outcome of HIV infected persons and describe temporal and geographical differences in the pattern of HIV-related morbidity, mortality, incidence, and prevalence in middle-income countries and resource-poor settings

Other Collaborations

The SHCS has collaborated to many other more punctual projects. Among these collaborative studies is an important evaluation of a new simple scoring system for the prognostic evaluation of patients starting treatment (Lundgren, 2002, JID). We further participated in a number of collaborative studies investigating the effect of antiviral treatment (first line as well as second line) on CD4 recovery, viral load, and mortality (Mocroft, 2002, AntivirTher; Mocroft, 2002 AIDS; Miller 2002 JID; Mocroft 2001 AIDS; Philips 2001 AIDS) as well as the epidemiological study of disease in the pre-HAART era (Blaxhult 2002 Epidemiology and Infect).

Another international collaboration was conducted with the European Study of the Natural History of HIV Infection in Women. In this study, natural history of cervical dysplasia and cancer in HIV infected women and the effect of HAART was studied (van Benthem AIDS 2002).

Collaboration has also been a hallmark of the MoCHiV project, which resulted in several publications in prestigious journals