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Liver Cancer

WIHS Viral Rebound and Resistance Study

The WIHS Viral Rebound and Resistance Study (VRS) has two components: a retrospective study that takes advantage of the extensive WIHS specimen and data repository to define the basic epidemiology of HAART failure as defined by rebound in plasma HIV RNA levels during treatment, and a prospective study that uses additional specimen and data collection to compare and contrast immunologic failure and virologic rebound with both resistant viral genotypes and wild-type virus. The specific aims of the retrospective research component include the following:

  1. To determine the incidence of virologic rebound during HAART therapy and the relative proportion of rebound from wild-type virus versus virus containing resistance mutations.

  2. To determine the outcomes associated with virologic rebound, with specific emphasis on distinguishing the effects of wild-type versus resistant genotype viral rebound over six months to six years HAART.

  3. To identify factors associated with virologic rebound, wild-type rebound, and rebound with resistance genotype. We specifically propose investigating the role of pre-HAART antiretroviral treatment exposure, pre-HAART HIV RNA level, pre-HAART CD4 cell count, pre-HAART stage of illness, risk behaviors and self-reported adherence to antiretroviral therapeutic (ART) regimens.

    The prospective research component is a nested substudy of WIHS participants at five clinical sites who have received HAART and have a documented CD4 cell response to this therapy for at least six months. The prospective study will be conducted over a 24 month period and provide a comprehensive model of factors that predict the outcome of HAART. This component will include data and specimen collection visits every three months (a visit frequency that will enable data collection proximate to key events such as virologic rebound and regimen switching). The specific aims of this component are:

  4. To determine if the viruses present in women exhibiting sustained immunological stability in presence of persistent viral rebound on HAART are intrinsically less biologically fit and, if so, to determine the molecular basis for this loss of fitness.

  5. To identify predictors and outcomes of immunologic failure, virologic rebound and clinical events, including those listed in aim three. Additional predictors include antiretroviral drug levels, (compared with pharmacokinetic data developed for each subject), reporting of acute illnesses and switches in antiretroviral regimen.

This projects is funded by the National Institutes of Allergy and Infectious Diseases.

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This page was last updated on
May 2001.