Materials and Links

Background:

HIV disease and its therapies are associated with increased risk for cardiovascular (CV) disease. Teasing out the risk attributable to HIV itself vs. the risk potentially attributable to specific antiretrovirals is a difficult task. A better understanding of the increased risk and its etiology is important for clinical management, treatment guideline generation and regulatory policies.

Observational cohort studies provide most of the data for signal generation and pharmacoepidemiologic studies. Several large databases are available, including the D:A:D study, the  French Hospital Database, the US Veteran's Administration cohort, the MACS and the WHIS, as well as meta-analysis of industry and network sponsored randomized clinical trials. The databases differ with respect to nature of data being collected, availability of control populations within the cohort itself, outcome definitions as well as demographics of the populations being followed. Lack of standardization and the structural differences among these datasets impede cross-study comparisons. Yet clinical guidelines committees and regulatory agencies are increasingly dependent on observational studies and their analyses for formulating guidance and policies. Clinicians and patients are faced with an array of information, sometimes conflicting, making decisions on best treatment strategy difficult.

The Forum for Collaborative HIV Research launched a new project addressing the research gap in cardiovascular risk. The project consists of a series of focused roundtables (see below), a public dialogue and a satellite symposium associated with the XVIII International AIDS Conference in Vienna. Participants include representatives from the community, US and European regulatory agencies, preventive and clinical cardiologists, HIV clinicians and academic researchers, experts in inflammatory and immunological biology, pharmaceutical industry, and the HAART Oversight Committee.

Objectives:

Roundtable #1: Review of Statistical and Epidemiological Approaches for Assessing CVD Risk Using Data from Observational Cohort Studies, Randomized Clinical Trials and Meta-Analyses

Review statistical analyses that have been performed, discuss potential gaps that exist and whether (and how) these gaps could be addressed with additional data analyses and collaborative efforts

Roundtable #2: Mechanism and Pharmacodynamics Explaining Increased Cardiovascular Disease

Discuss potential explanations, drawing on information from basic science, animal studies, clinical and population level data

Develop a research agenda

Roundtable #3: What is the clinical impact of the observed increased cardiovascular risk and how do we translate the research information into guidelines?

Develop a better understanding of the clinical impact of increased CV disease risk in HIV disease and treatment from the clinical guidelines and regulatory perspective

Discuss mechanisms to increase the robustness of findings, such as confirmatory studies and independent evaluation

Public Dialogue:

Review the findings from previous and invite public input

Review of previous Forum roundtables on the statistical, biological and clinical implications of CVD risk in patients with HIV infection

• Review and discuss current knowledge of the pathophysiology of CVD in patients with HIV
• Understand how to best use observational cohorts in assessing CVD risk
• Understand the clinical implications as regards practice, guidelines and regulatory issues

Satellite Symposium:

Review and disseminate the findings from the previous meetings

Please click here to view the agenda.

Status:

Roundtables #1 and #2 were held May 11^th and 12^th, respectively, at the Artemis Hotel in Amsterdam, The Netherlands.

Roundtable #3 and an open public meeting were held June 22^nd and 23^rd, respectively, at the Doubletree Hotel in Washington, D.C.

Satellite Symposium: Sunday, July 18^th, 1:30-3:30 PM, Session Hall 4; Reed Messe Conference Center, Vienna

Steering Committee Members: