This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This is an observational study to assess the outcome when patients who have been on highly active antiretroviral therapy (ART) discontinue therapy. While ART may well lead to significant reductions in viral load and recovery of CD4+ cell counts, it is often associated with morbidities that impact patient quality of life. For these reasons and the overall difficulty of adhering to the medication regimen, patients may wish to discontinue therapy. Aside from these issues, however, there have been positive aspects to treatment interruptions theorized, including passing virologic control to the patient's own immune system and an observation that the virus may revert to wild-type. Although this has not been seen to lead to successful long-term management of the disease, in could reduce costs and improve quality of life. In this study, an attempt is made to understand what will happen if patients discontinue treatment. It is assumed that all patients will eventually fail to maintain an acceptable CD4+ count and will resume ART. Retrospective studies indicate that predictors of the outcome of a treatment discontinuation include host factors and CD4+ levels prior to ART cessation. Accordingly, the major hypothesis of this study is that factors such as the CD4+ nadir and CD4+ gain on ART will be predictive of more rapid progression and some HLA class I loci will predict slower progression. Secondary hypotheses include the increase of quality of life, reduced costs until ART is resumed and that the early virologic response after ART resumption will predict subsequent virologic response. Subjects with > 6 months of ART and have CD4 >350 will stop ART. ART will be reinitiated if CD4 drops to <250 RNA and CD4, to be measured every 4 weeks for just 4 months and then every 8 weeks until 48 weeks, and and then every 12 weeks until 96 weeks. This is, in effect, a natural history study. It assumes that 40% of subjects will restart ART. This study will try to consolidate and clarify the consequences of ART cessation. Options for the management of the HIV+ patient may be improved as a result. This study is continuing to recruit and enroll subjects. No findings have been reported.
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