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Dolutegravir + Rilpivirine Switch Study (DORISS)

NCT02069834 · Status: WITHDRAWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL

Last updated 2015-08-28

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Nantes University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2017-10-31
Completion
2017-10-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02069834 on ClinicalTrials.gov