QDISS Stud: QD Isentress as Switch Strategy in Virologically Suppressed HIV-1 Infected-Patient (QDISS)

May 15, 2020 updated by: Nantes University Hospital

QD Isentress as Switch Strategy in Virologically Suppressed HIV-1 Infected-Patient

Raltegravir (RAL) is a very effective antiretroviral drug with a favorable long term tolerability. RAL offers many advantages such as lack of drug-drug interactions, a good safety profile particularly on lipids, inflammation and bone parameters. Ral can be an very interesting for patient with comorbidities and comedications, intolerance or toxicities with their current ARV treatment. However its current formulation of one tablet of 400mg twice a day coul not suit many patients.

A new once-a-day formulation of RAL has been developed, with two tablets of 600 mg QD. Pharmacokinetic study in healthy volunteers has shown that this dosing provides increased RAL exposure compared to the standard formulation of 400 mg given twice a day.

The objective of this study is to evaluate the maintain of virologic suppression with raltegravir 600mg 2 tablets qd as part of a triple antiretroviral regimen in virologically controlled patients.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France
        • CHU de Bordeaux
      • Le Mans, France
        • CH du Mans
      • Lyon, France
        • CHU de Lyon
      • Montpellier, France
        • CHRU de Montpellier
      • Nantes, France
        • CHU of Nantes
      • Nice, France
        • Chu de Nice
      • Orléans, France
        • CHR Orléans
      • Paris, France
        • Hopital Necker
      • Paris, France
        • CHU de Bichat
      • Paris, France
        • Chu Hotel Dieu
      • Paris, France
        • CHU La Pitié
      • Paris, France
        • Hôpital Avicenne
      • Paris, France
        • Hôpital St Louis
      • Reims, France
        • CHU de Reims
      • Tourcoing, France
        • CH de Tourcoing
      • Tours, France
        • CHRU de Tours
      • la Roche Sur Yon, France
        • CH de LA ROCHE sur YON

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adults of both gender ≥ 18 years
  • Signed informed consent form
  • Documented HIV-1 infection
  • Stable antiretroviral therapy for ≥ 6 months consisting of 2 NRTIs (TDF/FTC or ABC/3TC )+ a 3rd agent either as a once or twice daily regimen, unless there is intolerance requiring change of therapy. In this situation of intolerance, patient with less than 6 months of current antiretroviral therapy will be allowed in the study.

As soon as TAF/FTC will be available in France, patients receiving TAF/FTC + 3rd agent could be enrolled.

Switch of TDF/FTC to TAF/FTC will be authorized as long as the change has occurred for more than 3 months prior to the screening visit. Such switch will be also allowed during the study, and, unless urgently needed, after the W24 visit.

Patients on stable raltegravir 400 mg 1 tablet twice daily plus 2 NRTI can be enrolled; number of these patients will be limited to 33% of the total cohort.

  • Indication to current change antiretroviral therapy for at least one of the following reasons :

    1. Intolerance or prevention of toxicity
    2. Presence of a comorbid condition justifying change of the 3rd agent
    3. Management of drug-drug-interaction
    4. Patient's request, including switch to simplify or to improve convenience
  • No prior virological failure on integrase-containing antiretroviral therapy or NNRTI-containing antiretroviral therapy or NRTI only-therapy
  • HIV-1 RNA < 50 c/mL for ≥ 6 months. However, a single HIV-1 RNA ≥ 50 copies/mL and < 200 copies/mL with a subsequent HIV-1 RNA < 50 c/mL in the past 6 months is allowed.
  • AST and ALT < 5 times the upper limit of normal
  • Estimated glomerular filtration rate by MDRD equation >= 50 mL/min
  • Hemoglobin > 8 g/dL
  • Platelet count > 50 0000/mm3
  • For women of childbearing potential: negative serum test for pregnancy and acceptance to use contraceptive methods
  • Affiliation to a French Social Security program.

Exclusion Criteria:

  • HIV-2 co-infection
  • Concomitant treatments contra-indicated with raltegravir
  • Patients receiving raltegravir 400mg, 2 tablets in one daily intake
  • Patients with prior virological failure on NRTI+PI/r based regimen can be enrolled as long as historical plasma genotype and/or screening DNA genotype demonstrate absence of resistance or possible resistance to any drug. Subjects with previous failure to any other antiretroviral regimen cannot be enrolled.
  • Presence of possible resistance or resistance to any nucleoside reverse transcriptase inhibitor or integrase inhibitor on a historical plasma genotype.
  • Presence of possible resistance or resistance to any non- nucleoside reverse transcriptase inhibitor on a historical plasma genotype, with the exception of polymorphic mutations E138A/G/K/Q/R/S and V179D in patients naïve to NNRTI.
  • Presence of resistance to any PI on a historical plasma genotype

In case were historical plasma genotype being not available or incomplete, resistance genotype will be performed on DNA at screening visit. Full treatment and cumulative resistance genotype history will have to be provided, at screening, to the principal investigator to approve any inclusion.

  • For HCV co-infected patients, if specific treatment for hepatitis is required during the trial duration, such HCV therapy should be compatible with the ARV combination and only started after the W24 visit.
  • HBV infection, in the absence of treatment with TDF or TAF
  • Severe associated diseases requiring specific treatment, such as curative treatment of acute opportunistic infection
  • Treatment with interferon, interleukin or any immunotherapeutic agent or chemotherapy
  • Cancer diagnosis in the past 3 years with the exception of Kaposi sarcoma
  • Subjects participating in another clinical trial evaluating therapies and having an exclusion period that is still ongoing during the screening phase
  • Any condition which might compromise the safety of treatment and/or patient's adherence to trial procedures
  • Person under guardianship, trusteeship or deprived of freedom by a judicial or administrative decision
  • Difficulty in terms of follow-up (vacation, job transfer, geographical distance, lack of motivation)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Raltegravir
antiretroviral tritherapy: Raltegravir 600 mg tablet orally (2 tablets QD) and 2 Nucleoside/Nucleotide reverse transcriptase inhibitor (NRTI)
Drug: Raltegravir and 2 Nucleoside/Nucleotide reverse transcriptase inhibitor (NRTI)
All virologically suppressed

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Number of copie/ml plasma HIV - RNA
Time Frame: 48 weeks
48 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Score evaluation of patient satisfaction
Time Frame: 48 weeks
48 weeks
Score evaluation of patient quality of life with PROQOL-HIV questionnaires
Time Frame: 48 weeks
48 weeks
Score evaluation of adherence
Time Frame: 48 weeks
48 weeks
Number of incidence of Treatment-Emergent Adverse Events
Time Frame: 48 weeks
48 weeks
Number of patient who have a viral load < 50 copies/ml
Time Frame: 48 weeks
48 weeks
number of discontinuation of Raltegravir
Time Frame: 48 weeks
48 weeks
number of treatment failure
Time Frame: 48 weeks
48 weeks
number of genotype resistance mutations
Time Frame: 48 weeks
48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nantes University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 8, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 30, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 6, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 29, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 19, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 22, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 19, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 15, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RC16_0317

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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