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Clinical trial

Dolutegravir + Rilpivirine Switch Study (DORISS)

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Last updated:18th Feb 2014

The primary objective of the study is to evaluate the capacity of Dolutegravir + Rilpivirine vs. continued triple combination HAART to maintain plasma HIV RNA ≤ 50 copies/ml throughout 24 weeks in patients with plasma HIV RNA ≤ 50 copies/mL for at least 2 years under conventional HAART (2 NNRTI + 3rd agent).

The main secondary objectives are the following:

- % of virologic success (plasma viral load ≤ 50 copies/mL) at W24 and W48
- % of patients who maintain a plasma viral load ≤ 50 copies / ml from D0 to W48
- % of virological failure defined by two consecutive plasma viral load > 50 copies/mL

Profile of genotypic resistance in case of virological failure.

The trial will be conducted according to the design below, in 3 steps:

- Step 1: enrollment of 80 patients (40 in each arm)
- Step 2: enrollment on hold until W16 data from the 40 patients enrolled in the intervention arm have been analyzed.
- Step 3: resumption and completion of enrollment if conditions for resuming enrollment at the end of step 2 are fulfilled, i.e. if the percentage of patients randomized to the intervention arm who have a plasma viral load ≤ 50 copies/mL from D0 to W16 is significantly > 70%, which translates in a maximum of 6 virologic failures.

Category Value
Study start date 2014-02-18

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