QDISS Stud: QD Isentress as Switch Strategy in Virologically Suppressed HIV-1 Infected-Patient
QDISS
QD Isentress as Switch Strategy in Virologically Suppressed HIV-1 Infected-Patient
1 other identifier
interventional
100
1 country
17
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Nov 2017
17 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
May 29, 2017
CompletedFirst Posted
Study publicly available on registry
June 22, 2017
CompletedStudy Start
First participant enrolled
November 8, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 6, 2020
CompletedMay 19, 2020
May 1, 2020
2 years
May 29, 2017
May 15, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of copie/ml plasma HIV - RNA
48 weeks
Secondary Outcomes (8)
Score evaluation of patient satisfaction
48 weeks
Score evaluation of patient quality of life with PROQOL-HIV questionnaires
48 weeks
Score evaluation of adherence
48 weeks
Number of incidence of Treatment-Emergent Adverse Events
48 weeks
Number of patient who have a viral load < 50 copies/ml
48 weeks
- +3 more secondary outcomes
Study Arms (1)
Raltegravir
EXPERIMENTALantiretroviral tritherapy: Raltegravir 600 mg tablet orally (2 tablets QD) and 2 Nucleoside/Nucleotide reverse transcriptase inhibitor (NRTI)
Interventions
All virologically suppressed
Eligibility Criteria
You may qualify if:
- 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 :
- Intolerance or prevention of toxicity
- Presence of a comorbid condition justifying change of the 3rd agent
- Management of drug-drug-interaction
- 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
- +5 more criteria
You may not qualify if:
- 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
- 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
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
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
Related Publications (1)
Hall N, Allavena C, Katlama C, Jobert A, Molina JM, Cua E, Bani-Sadr F, Hocqueloux L, Duvivier C, Merrien D, Hikombo H, Andre-Garnier E, Gaultier A, Raffi F; QDISS Study Group. Raltegravir 1200 mg once daily as maintenance therapy in virologically suppressed HIV-1 infected adults: QDISS open-label trial. AIDS Res Ther. 2022 Jan 15;19(1):4. doi: 10.1186/s12981-022-00428-5.
PMID: 35033092DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Masking Details
- Open label
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 29, 2017
First Posted
June 22, 2017
Study Start
November 8, 2017
Primary Completion
October 30, 2019
Study Completion
May 6, 2020
Last Updated
May 19, 2020
Record last verified: 2020-05