Study Stopped
One of the both Funder partners decided to stop the study before the initiation : thus no product provided and no funding to realize the study
Dolutegravir + Rilpivirine Switch Study (DORISS)
DORISS
2 other identifiers
interventional
N/A
1 country
25
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started May 2014
Typical duration for phase_2
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 18, 2014
CompletedFirst Posted
Study publicly available on registry
February 24, 2014
CompletedStudy Start
First participant enrolled
May 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2017
CompletedAugust 28, 2015
August 1, 2015
3.4 years
February 18, 2014
August 27, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Pilot phase: Percentage of patients with plasma viral load ≤ 50 copies HIV-RNA/ml from D0 (Day 0) to W16 (Week 16)
Week 16
Non-inferiority phase: Percentage of patients with plasma HIV RNA maintained ≤ 50 copies/mL throughout 24 weeks
Week 24
Secondary Outcomes (24)
Percentage of patients with plasma viral load ≤50 HIV RNA copies/mL at Week 24 and Week 48
Week 48
Percentage of patients with plasma viral load ≤50 HIV RNA copies/mL from Day 0 to Week 48
Week 48
Percentage of virologic failure, defined as 2 consecutive plasma HIV RNA > 50 copies/mL
Week 48
Measure of the profile of genotypic resistance in plasma in case of virologic failure
Week 48
Percentage of patients who discontinued or changed the strategy of the study
Week 48
- +19 more secondary outcomes
Study Arms (2)
Arm 1 (intervention)
EXPERIMENTALDolutegravir 50 mg/d + Rilpivirine 25 mg/d qd orally (intake during a meal)
Arm 2 (control)
ACTIVE COMPARATORContinuation of existing HAART at the time of randomization
Interventions
Dolutegravir 50 mg/j + Rilpivirine 25 mg/j qd orally (intake during meal)
Eligibility Criteria
You may qualify if:
- Age ≥ 18 years
- HIV-1 infection
- Treatment with suppressive triple HAART (2 NRTI + either 1 PI/r, or 1 NNRTI, or INI), unchanged for \> 6 months, Intra-class substitution within past 6 months is not considered as a treatment change.
- Plasma HIV-RNA ≤ 50 copies/mL for \> 2 years
- CD4 cell count \> 350/mm3 for \> 6 months
- No prior virologic failure under an NNRTI-containing or an INSTI-containing ART regimen
- No NNRTI mutation on pre-ART genotype (if no pre-ART genotype available: no NNRTI mutation on DNA genotype at screening) among the following: K101E/P, E138A/G/K/Q/R/S, V179L, Y181C/I/V, Y188L, H221Y, M230I/L/V, L100I + K103N/S, L100I +K103R +V179D.
- No mutation (either on pre-ART genotype or on DNA genotype at screening) among the following: T66K, G118R, V151L, S153F/Y, R263K, T66K + L74M, E92Q + N155H, Q148R +N155H, Q148H/K/R with at least one mutation of L74I or E138A/K/T or G140A/C/S
- Negative HBs Ag
- Informed consent form signed by patient and investigator
- A specific consent for the pharmacokinetic substudy will be signed by the 10 patients of the pilot phase of the trial who will be randomized to the Dolutegravir + Rilpivirine arm and will volunteer for this PK study
- Patient covered with health insurance
- Effective contraception
You may not qualify if:
- HIV-2 infection
- Dialysis or severe renal failure (creatinine clearance \< 30 ml/min)
- History of decompensated liver disease
- History of HIV-associated neurocognitive disorders
- AST or ALT \> 5 x ULN
- Positive HBc Ac and negative HBs Ac
- Patient receiving a proton pump inhibitor that cannot be switched to another anti-secretory drug
- Current pregnancy or breastfeeding
- Patient involved in another research that precludes enrolment in another trial
- Patient under guardianship, or deprived of liberty by a court or administrative decision.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
CHU Guadeloupe
Point-a-pitre, Guadeloupe, 97159, France
CHU de Fort de France
Fort de France, Martinique, 87261, France
Chu Jean Minjoz
Besançon, 25030, France
Hôpital Avicenne
Bobigny, 93000, France
Hôpital Jean Verdier
Bondy, 93140, France
CHU de Bordeaux
Bordeaux, 33076, France
CHU de DIJON
Dijon, 21079, France
CHD La Roche sur Yon
La Roche-sur-Yon, 85925, France
CHU Kremlin Bicêtre
Le Kremlin-Bicêtre, 94275, France
Hôpital Perpetuel Secours
Levallois-Perret, 92300, France
CHU de Nantes
Nantes, 44093, France
CHU Hôtel Dieu Paris
Paris, 75004, France
Hôpital La Pitié Salpêtrière
Paris, 75013, France
Hôpital Necker - enfants Malades
Paris, 75015, France
Hôpital Saint Louis
Paris, 75475, France
CHU BICHAT - Claude Bernard
Paris, 75877, France
Hôpital Européen Georges Pompidou
Paris, 75908, France
CHU de Rennes - Hôpital Pontchaillou
Rennes, 35000, France
CH Delafontaine
Saint-Denis, 93200, France
CHU Saint Etienne
Saint-Etienne, 42055, France
CHU de Strasbourg
Strasbourg, 67091, France
Hôpital FOCH
Suresnes, 92150, France
CHU Toulouse
Toulouse, 31059, France
CHRU de Tours
Tours, 37044, France
CHU de Nancy
Vandœuvre-lès-Nancy, 54511, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 18, 2014
First Posted
February 24, 2014
Study Start
May 1, 2014
Primary Completion
October 1, 2017
Study Completion
October 1, 2017
Last Updated
August 28, 2015
Record last verified: 2015-08