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ACTG 5164 Published: Early HAART Reduces
AIDS/Death in Individuals with Acute OIs
  Early Antiretroviral Therapy Reduces AIDS Progression/Death in Individuals with Acute Opportunistic Infections: A Multicenter Randomized Strategy Trial
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"we recommend that ART be started early in the setting of acute AIDS-related OIs if there are no major contraindications to doing so. Waiting to complete OI treatment before initiating ART appears to be associated with a higher risk of AIDS-related disease progression and/or death without any significant benefit in terms of safety or virological response."
"There was a significant difference favoring the early treatment group in the secondary outcome of AIDS progression/death. The impact is seen primarily on morbidity and mortality events in the first 6 months (see Figure 3), suggesting that early improvement in immune responsiveness is critical to prevent clinical progression. Subjects in the early ART arm spent less time with CD4 counts <50 or <100 and therefore the "window of vulnerability" to additional AIDS-related complications was shortened by early use of ART. The idea that ART seems to have an early effect on the clinical course following an OI is supported by our finding that early ART was beneficial even though the difference in the time to initiation of ART following the OI was only about 1 month. The difference in outcomes could not be explained by differences in ART regimens used, adherence, adverse events or number of hospitalizations (which were similar in the two arms).
Because AIDS progression/death was not the primary outcome of our study, we recognize that our results should be interpreted cautiously. On the other hand, AIDS progression/death is an important (it could be argued the most important) outcome for ART trials, and our results are consistent with the biologic effects of ART treatment."
"Our study can be viewed as demonstrating the efficacy of early ART since there was selection by treating clinicians for patients that were likely to be "good" clinical trial candidates. We have no way to know how much "pre-screening" of patients occurred but treating clinicians were instructed to use "best clinical judgment" in selecting patients for the study. Although there was likely some "pre-selection" of patients, this is no different than any other randomized clinical trial and since there were 40 participating sites across a wide spectrum of clinical settings in the US (and South Africa) we feel the study results are fairly generalizable."
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