From the Executive Summary
From 30 July to 1 August 1999, a diverse, internation al group of biomedical researchers, statisticians, clinicians, research administrators and community treatment advocates met to discuss and develop plans for research on structured treatment interruptions (STIs) in the context of highly active antiretroviral therapy (HAART). Participants reviewed observations to date, currently available virologic, immunologic and clinical hypotheses, and reviewed studies now underway or in the planning stages. They evaluated STI research in the context of fully-virally suppressed patients with primary or chronic HIV infection, and multi-drug resistant (MDR) patients who are failing to achieve full viral suppression. In a series of intradisciplinary and in terdisciplinary breakout-groups, participants identified gaps in current STI research and developed several proposals and mechanisms to address these gaps, and to coordinate and expedite the overall STI research effort. Among the conclusions and follow-up steps to emerge by consensus from the STI Workshop were the following:
- The need to establish a prospective observational STI cohort study to pool observations regarding patients who elect to undergo an STI and to assess its safety, efficacy, and virologic, immunologic and clinical impact;
- The need to establish an STI Laboratory Working Group to pool resources and improve the ability of researchers to take advantage of new virologic, immunologic and pathologic assays;
- The need to develop and promulgate a carefully-worded and thought-out clinical practice guideline outlining the potential risks & benefits, and the knowns and (far more) the unknowns about undertaking an STI at various stages of HIV disease;
- The need to address pharmacologic and quality-of-life considerations in STI research; and
- The need to coordinate STI research, particularly vis-à-vis studies of STIs in heavily pretreated patients with few treatment options and (possibly) low CD4 T cell counts, or those at risk for a CD4 T cell plunge or clinical progression during an STI.
Workshop participants discussed these and other objectives. The following report summarizes the workshop proceedings and the discussions that led to the workshop conclusions and follow-up recommendations. The STI Steering Committee will undertake to facilitate their implementation.