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Example sentences for: reinitiation
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Forty-two eligible patients from the Jonathan Lax Immune Disorder Clinic in Philadelphia, Pennsylvania, were randomized via sealed envelopes in a 1:1 fashion to a first phase (phase I) of either (1) three successive TIs of 2, 4, and 6 wk, respectively, or (2) maintenance of ART for 40 wk before a final interruption of therapy in both arms (phase II) subject to therapy reinitiation criteria as described below.
Following reinitiation of therapy after phase II, patients suppressed viral replication to less than 50 copies/ml by a median time of 10 (6–12) wk in both arms, excluding for two patients in the continuous therapy/single interruption arm who elected to stay off ART indefinitely and one patient from the repeated interruptions arm who reported nonadherence following regimen reinitiation yet reached 52 copies/ml before withdrawing from additional follow-up.
It is of interest to note that despite the large amount of research activity on TIs in patients with suppressed chronic infection and the hundreds of monitored interruptions studied to date, only limited cases of development of clinical resistance (as evidenced by a lack of viral resuppression following therapy reinitiation) have emerged, in contrast to the multiple reports of detection of viral sequences off ART associated with resistance as shown in this study and others [11,19,29,30,39,40].
Phase II procedures for both arms included the following: (1) monitoring for patient study withdrawal criteria as described in phase I, (2) determining time to primary end point of a viral load greater than 5,000 copies/ml, (3) monitoring until the time of therapy reinitiation at a viral load greater than 30,000 copies/ml for three consecutive time points, and (4) after reinitiation of therapy, follow-up on therapy to confirm resuppression to less than 50 copies/ml at 6, 10, and 14 wk on therapy.
Using these criteria for reinitiation of therapy and to define failure, 11 of 14 patients (79%) were able to achieve virologic control to less than 5,000 RNA copies/ml plasma for at least 90 d after one, two, or three treatment interruptions (Table 2).
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