NCT02069834

Dolutegravir + Rilpivirine Switch Study (DORISS)

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

• Status: Withdrawn
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Nantes University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HIV Infection
• HAART-treated
• Virologically Controlled

Interventions

Type	Name	Description
DRUG	Arm 1 (intervention)	Dolutegravir 50 mg/j + Rilpivirine 25 mg/j qd orally (intake during meal)
DRUG	Arm 2 (control)	Continuation of existing HAART at the time of randomization

Timeline

• Start date: 2014-05-01
• Primary completion: 2017-10-01
• Completion: 2017-10-01
• First posted: 2014-02-24
• Last updated: 2015-08-28

Locations

25 sites across 1 country: France