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Structured Treatment Interruptions Workshop Summary

January 31, 2001

Progress in STI Research:
The Outlook for Immune Response

The State of the Hypotheses for STI

Primary Infection

Hypothesis Evidence Next Step
Treat briefly to lower the viral setpoint and allow people to live longer with less drug exposure. We have anecdotal evidence that this is possible. Determine long-term benefit and safety.

Chronic Infection, Suppressed Virus

Hypothesis Evidence Next Step
Attain remission through HIV-1-specific immune control. There is evidence that this occurs in some patients. Identify responders and increase the proportion that responds.
Get acceptable clinical results with less drug exposure and prevent death and disease. There is evidence that abnormal lab values can recover during interruption; there is little evidence that drug-related symptoms recover, at least during the short interruption periods studied so far. Identify patients for whom this is safe.

Chronic Infection, Unsuppressed Virus

Hypothesis Evidence Next Step
Reduce toxicity by periodically stopping drug treatments. There is evidence that abnormal lab values can recover during interruption; there is evidence that fat redistribution does not improve. Practice careful medical management to minimize the risk of clinical events in patients with low and declining CD4+ cell counts.
Re-sensitize the virus to antiretroviral drugs so patients can avoid death and disease by returning to therapy and suppressing virus. The goal should be to maintain CD4+ cell counts and preserve immune repertoire. There is evidence that shift to WT virus can occur -- but drug susceptibility is eventually lost when therapy is reintroduced. Time required for shift to WT usually results in significant CD4+ cell count declines. These declines are greatest in those with higher CD4+ counts.

Identify patients for whom this is safe.

Identify patients for whom this can be predicted.

Outstanding Immunology Issues

There is a crucial need to standardize:

Correlate new assays with standard assays

Expand the use of animal models


Outstanding Virology Issues

What are the virologic determinants for HIV-1-specific immune stimulation?

Virus rebound -- Immunogenic stimulus

Virus rebound -- Antigenic stimulus

Drug exposed virus -- Drug pressure

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