HIV Infection Clinical Trial
Official title:
Dolutegravir + Rilpivirine Switch Study (DORISS): Pilot and Noninferiority Trial Comparing Dolutegravir + Rilpivirine vs. Continued HAART (Highly Active Antiretroviral Therapy) in Patients With Plasma HIV RNA ≤ 50 Copies/mL for at Least 2 Years
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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