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Dolutegravir + Rilpivirine Switch Study (DORISS) (DORISS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02069834
Recruitment Status : Withdrawn (One of the both Funder partners decided to stop the study before the initiation : thus no product provided and no funding to realize the study)
First Posted : February 24, 2014
Last Update Posted : August 28, 2015
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
HIV Infection HAART-treated Virologically Controlled Drug: Arm 1 (intervention) Drug: Arm 2 (control) Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : May 2014
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : October 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm 1 (intervention)
Dolutegravir 50 mg/d + Rilpivirine 25 mg/d qd orally (intake during a meal)
 Drug: Arm 1 (intervention)
Dolutegravir 50 mg/j + Rilpivirine 25 mg/j qd orally (intake during meal)
Active Comparator: Arm 2 (control)
Continuation of existing HAART at the time of randomization
 Drug: Arm 2 (control)
Continuation of existing HAART at the time of randomization


Outcome Measures
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Primary Outcome Measures :
  1. Pilot phase: Percentage of patients with plasma viral load ≤ 50 copies HIV-RNA/ml from D0 (Day 0) to W16 (Week 16) [ Time Frame: Week 16 ]
  2. Non-inferiority phase: Percentage of patients with plasma HIV RNA maintained ≤ 50 copies/mL throughout 24 weeks [ Time Frame: Week 24 ]

Secondary Outcome Measures :
  1. Percentage of patients with plasma viral load ≤50 HIV RNA copies/mL at Week 24 and Week 48 [ Time Frame: Week 48 ]
  2. Percentage of patients with plasma viral load ≤50 HIV RNA copies/mL from Day 0 to Week 48 [ Time Frame: Week 48 ]
  3. Percentage of virologic failure, defined as 2 consecutive plasma HIV RNA > 50 copies/mL [ Time Frame: Week 48 ]
  4. Measure of the profile of genotypic resistance in plasma in case of virologic failure [ Time Frame: Week 48 ]
  5. Percentage of patients who discontinued or changed the strategy of the study [ Time Frame: Week 48 ]
  6. Measure of the HIV-DNA between day 0 and week 48 [ Time Frame: W48 ]
    Evolution of the HIV-DNA between Day 0 and week 48

  7. Measure of CD4 lymphocytes at week 24 compared to day 0 [ Time Frame: Week 24 ]
    Evolution of CD4 lymphocytes (average) at Week 24 compared to Day 0

  8. Measure of CD4 lymphocytes at Week 48 compared to Day 0 [ Time Frame: Week 48 ]
    Evolution of CD4 lymphocytes (average) at Week 48 compared to Day0

  9. Number of patients with adverse events of grade 2 to 4 [ Time Frame: Week 48 ]
    Adverse events : incidence, grade and relation to study medication of all adverse events, of grade 2 to 4 events

  10. Measure of changes in serum plasma lipid parameters at week 24 compared to Day 0 [ Time Frame: Week 24 ]
    Mean changes in serum plasma lipid parameters at Week 24 compared to Day 0

  11. Measure of changes in serum lipid parameters at week 48 to Day 0 [ Time Frame: Week 48 ]
    Mean changes in serum plasma lipid parameters at Week 48 compared to Day 0

  12. Measure of changes in fat mass distribution at week 24 compared to Day 0 [ Time Frame: Week 24 ]
    Changes in fat mass distribution at Week 24 compared to Day 0

  13. Measure of changes in fat mass distribution at Week 48 compared to Day 0 [ Time Frame: Week 48 ]
    Changes in fat mass distribution at Week 48 compared to Day 0

  14. Measure of adherence to treatment at Week 24 compared to Day 0 [ Time Frame: Week 24 ]
    Evolution of adherence to treatment at Week 24 compared to Day 0 assessed by a validated questionnaire

  15. Measure of adherence to treatment at Week 48 compared to Day 0 [ Time Frame: Week 48 ]
    Evolution of adherence to treatment at Week 48 compared to Day 0 assessed by a validated questionnaire

  16. Measure of patient satisfaction for their treatment at Day 0 [ Time Frame: Day 0 ]
    Assessment of patient satisfaction for their treatment at D0 by questionnaire

  17. Measure of patient satisfaction for their treatment at Week 24 [ Time Frame: Week 24 ]
    Assessment of patient satisfaction for their treatment at Week 24 by questionnaire

  18. Measure of patient satisfaction for their treatment at Week 48 [ Time Frame: Week 48 ]
    Assessment of patient satisfaction for their treatment at Week 48 by questionnaire

  19. Measure of changes in plasma biomarkers of inflammation (hs-CRP and IL-6) and immune activation (sCD14 , MCP -1, IP10 ) at Week 24 compared to Day 0 . [ Time Frame: Week 24 ]
    Changes in plasma biomarkers of inflammation (hs-CRP and IL-6) and immune activation (sCD14 , MCP -1, IP10 ) at Week 24 compared to Day 0 .

  20. Measure of changes in plasma biomarkers of inflammation (hs-CRP and IL-6) and immune activation (sCD14 , MCP -1, IP10 ) at Week 48 compared to Day 0 . [ Time Frame: Week 48 ]
    Changes in plasma biomarkers of inflammation (hs-CRP and IL-6) and immune activation (sCD14 , MCP -1, IP10 ) at Week 48 compared to Day 0 .

  21. Measure of plasma concentrations of Dolutegravir and Rilpivirine measured at Week 4 [ Time Frame: Week 4 ]
    Analysis PK (PharmacoKinetic) / PD (Pharmaodynamic) of plasma concentrations of Dolutegravir and Rilpivirine measured at Week 4

  22. Measure of plasma concentrations of Dolutegravir and Rilpivirine measured at Week 24 [ Time Frame: Week 24 ]
    Analysis PK / PD of plasma concentrations of Dolutegravir and Rilpivirine measured at Week 24

  23. Measure of the profile of genotypic resistance in plasma in case of virologic failure [ Time Frame: Week 24 ]
  24. Percentage of virologic failure, defined as 2 consecutive plasma HIV RNA > 50 copies/mL [ Time Frame: Week 24 ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02069834


Locations
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Sponsors and Collaborators
Nantes University Hospital
More Information
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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT02069834    
Other Study ID Numbers: RC13_0322
2013-003344-23 ( EudraCT Number )
First Posted: February 24, 2014    Key Record Dates
Last Update Posted: August 28, 2015
Last Verified: August 2015
Keywords provided by Nantes University Hospital:
Dolutegravir
Rilpivirine
PI- and NRTI- sparing ART regimen
switch study
Additional relevant MeSH terms:
Layout table for MeSH terms
HIV Infections
Blood-Borne Infections
Communicable Diseases
Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
 Retroviridae Infections
RNA Virus Infections
Virus Diseases
Genital Diseases
Urogenital Diseases
Immunologic Deficiency Syndromes
Immune System Diseases