Dolutegravir + Rilpivirine Switch Study (DORISS)

Summary

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.

Timeline

Start

2014-05

Primary completion

2017-10

Completion

2017-10

Drugs

Indications