Clinical Trials

MainTitle

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

This study has been completed
Sponsor
Nantes University Hospital


Information provided by (Responsible Party)
Nantes University Hospital
ClinicalTrials.gov Identifier
NCT03195452

First received: May 29, 2017
Last updated: May 15, 2020
Last Verified: May 2020
History of Changes
Purpose

Purpose

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.

Condition Intervention Phase
Virus-HIV

Drug : Raltegravir and 2 Nucleoside/Nucleotide reverse transcriptase inhibitor (NRTI)
Phase 2

Study Type: Interventional
Study Design: Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: QD Isentress as Switch Strategy in Virologically Suppressed HIV-1 Infected-Patient

Further study details as provided by Nantes University Hospital:

Primary Outcome Measures

  • Number of copie/ml plasma HIV - RNA [ Time Frame: 48 weeks ]
Secondary Outcome Measures:
  • Score evaluation of patient satisfaction [ Time Frame: 48 weeks ]
  • Score evaluation of patient quality of life with PROQOL-HIV questionnaires [ Time Frame: 48 weeks ]
  • Score evaluation of adherence [ Time Frame: 48 weeks ]
  • Number of incidence of Treatment-Emergent Adverse Events [ Time Frame: 48 weeks ]
  • Number of patient who have a viral load < 50 copies/ml [ Time Frame: 48 weeks ]
  • number of discontinuation of Raltegravir [ Time Frame: 48 weeks ]
  • number of treatment failure [ Time Frame: 48 weeks ]
  • number of genotype resistance mutations [ Time Frame: 48 weeks ]

Enrollment: 100
Study Start Date: November 8, 2017
Study Completion Date: May 6, 2020
Primary Completion Date: October 30, 2019 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
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

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

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)

contacts and locations

Contacts and Locations

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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03195452

Locations

France
CHU De Bordeaux
Bordeaux, France
CH de la Roche Sur Yon
la Roche Sur Yon, France
CH du Mans
Le Mans, France
CHU de Lyon
Lyon, France
CHRU de Montpellier
Montpellier, France
CHU of NANTES
Nantes, France
CHU de Nice
Nice, France
CHR orléans
Orléans, France
CHU de Bichat
Paris, France
CHu hotel dieu
Paris, France
CHU la pitié
Paris, France
Hopital Avicenne
Paris, France
Hopital Necker
Paris, France
Hopital St Louis
Paris, France
CHU de Reims
Reims, France
CH de Tourcoing
Tourcoing, France
CHRU de Tours
Tours, France

Sponsors and Collaborators

Nantes University Hospital
More Information

More Information


Responsible Party: Nantes University Hospital  
ClinicalTrials.gov Identifier: NCT03195452   History of Changes  
Other Study ID Numbers: RC16_0317  
Study First Received: May 29, 2017  
Last Updated: May 15, 2020  

Studies a U.S. FDA-regulated Drug Product: No  
Studies a U.S. FDA-regulated Device Product: No  

Keywords provided by Nantes University Hospital:

HIV
Antiretrovirals
Raltegravir

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Raltegravir Potassium
Reverse Transcriptase Inhibitors

ClinicalTrials.gov processed this data on May 28, 2020
This information is provided by ClinicalTrials.gov.