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Virus-HIVPhase 2QDISSNCT03195452

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

A Phase 2 study testing Raltegravir and 2 Nucleoside/Nucleotide reverse transcriptase inhibitor (NRTI) in people with Virus-HIV, run by Nantes University Hospital at 17 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Virus-HIV
What is being tested?
Raltegravir and 2 Nucleoside/Nucleotide reverse transcriptase inhibitor (NRTI)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
17 sitesFrance
Study dates
8 Nov 2017to 6 May 2020
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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
  • 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.

Who cannot join

  • 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.
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  • 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)

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

France17 sites

  • CHU De Bordeaux

    Bordeaux

  • CH de la Roche Sur Yon

    La Roche-sur-Yon

  • CH du Mans

    Le Mans

  • CHU de Lyon

    Lyon

  • CHRU de Montpellier

    Montpellier

  • CHU of NANTES

    Nantes

  • CHU de Nice

    Nice

  • CHR orléans

    Orléans

  • CHU de Bichat

    Paris

  • CHu hotel dieu

    Paris

  • CHU la pitié

    Paris

  • Hopital Avicenne

    Paris

  • Hopital Necker

    Paris

  • Hopital St Louis

    Paris

  • CHU de Reims

    Reims

  • CH de Tourcoing

    Tourcoing

  • CHRU de Tours

    Tours

Other trials in France

About this study

Official title: 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.

Conditions
Virus-HIV
Being tested
Raltegravir and 2 Nucleoside/Nucleotide reverse transcriptase inhibitor (NRTI)
Keywords
HIV, Antiretrovirals, Raltegravir
Medical subject headings
Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    All virologically suppressed

Study groups in NCT03195452
Study groupRoleWhat they receive
RaltegravirExperimentalantiretroviral tritherapy: Raltegravir 600 mg tablet orally (2 tablets QD) and 2 Nucleoside/Nucleotide reverse transcriptase inhibitor (NRTI)
Receives: Drug: Raltegravir and 2 Nucleoside/Nucleotide reverse transcriptase inhibitor (NRTI)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of copie/ml plasma HIV - RNA

    Measured: 48 weeks

Secondary outcomes (8)

  1. Score evaluation of patient satisfaction

    Measured: 48 weeks

  2. Score evaluation of patient quality of life with PROQOL-HIV questionnaires

    Measured: 48 weeks

  3. Score evaluation of adherence

    Measured: 48 weeks

  4. Number of incidence of Treatment-Emergent Adverse Events

    Measured: 48 weeks

  5. Number of patient who have a viral load < 50 copies/ml

    Measured: 48 weeks

  6. number of discontinuation of Raltegravir

    Measured: 48 weeks

  7. number of treatment failure

    Measured: 48 weeks

  8. number of genotype resistance mutations

    Measured: 48 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jun 2017
  2. Study start8 Nov 2017
  3. Primary completion30 Oct 2019
  4. Study completion6 May 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03195452
Sponsor's protocol ID
RC16_0317
Acronym
QDISS
Status last verified
May 2020
First submitted
29 May 2017
Last updated
14 Sep 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 35033092

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Raltegravir and 2 Nucleoside/Nucleotide reverse transcriptase inhibitor (NRTI) in people with Virus-HIV, run by Nantes University Hospital at 17 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of copie/ml plasma HIV - RNA (time frame: 48 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03195452, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.

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