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HIV-1 InfectionPhase 3NCT02247687

Management of Participants With Low-level Persistent Viremia (ANRS 161 L-VIR)

A Phase 3 study testing Protease inhibitor, Isentress® (raltegravir) and Counseling arm in people with HIV-1 Infection and Treatment Resistant Disorders, run by ANRS, Emerging Infectious Diseases at 20 sites in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Management of participants with low-level persistent viremia Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Protease inhibitor, Isentress® (raltegravir) and Counseling arm
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4 participants
Where
20 sitesFrance
Study dates
Dec 2014to Sep 2015
Phase
Phase 3
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

  • Age ≥ 18 years
  • HIV-1 infection
  • On combined antiretroviral regimen for at least 18 months
  • Participant with a stable antiretroviral regimen for at least 6 months, including 2 Reverse-transcriptase inhibitor (INTI) + 1 Boosted Protease Inhibitor IP/r ,
  • participant with at least 2 consecutive viral load between 50 and 500 copies/milliliter over the last 9 months (with at least 2 months between the two measurements) quantified with the same commercial kit.
  • 50 <or= VL < 500 copies/milliliter at screening visit quantified with the same commercial kit than previous one.
Show all 15Show fewer
  • Participant naïve to raltegravir (RAL)
  • failure of amplification or successful realization of genotypic resistance test without evidence for resistance mutations against current treatment (3TC/FTC accepted with M184V mutation)
  • creatinin < 3 Upper Limit normal (ULN)
  • Aspartate Amino Transférase (ASAT), Alanine Amino Transférase (ALAT) < 5 Upper Limit normal (ULN)
  • hemoglobin > 8 g/dL
  • platelets > 50 000/mm3
  • In women, lack of current pregnancy verified by Beta Human Chorionic Gonadotropin (βHCG) at week -4 visit and use of a mechanical contraceptive method
  • Informed consent
  • Participants with an active health insurance coverage (article L1121-11 du Code de la Santé Publique)

Who cannot join

  • HIV-2 infection,
  • severe medical condition in the last month (inclusion is possible for a stable condition at screening)
  • breastfeeding women, current pregnancy or planned pregnancy within 12 months.
  • participant currently receiving Prezista® (darunavir)/ Norvir® (ritonavir) (600/100 mg) two times a day (BID) (of note, participants receiving Prezista® (darunavir)/ Norvir® (ritonavir) one time a day (QD) can be included)
  • Hypersensitivity Prezista® (darunavir)/ Norvir® (ritonavir) or to any of the excipients of the study treatment
  • participant under judicial protection (judicial protection due to temporarily and slightly diminished mental or physical faculties), or under legal guardianship
  • planned absence that could prevent the patient from participating in the trial (travel abroad, moving, pending work transfer ...)

Trial locations and contacts

20 sites in 1 country.

20 sites in 1 country

France20 sites

  • Hôpital Avicenne

    Bobigny, 93000

  • Hôpital Jean Verdier

    Bondy, 93143

  • Hôpital Saint André

    Bordeaux, 33075

  • Hôpital Pellegrin

    Bordeaux, 33076

  • Hôpital de la côte de Nacre

    Caen, 14033

  • Hôpital Henry Mondor

    Créteil, 94010

  • Hôpital Européen Georges Pompidou

    France, 75674

  • Hôpital de Bicêtre

    Le Kremlin-Bicêtre, 94275

  • Hôpital de l'Hôtel Dieu

    Nantes, 44093

  • Hôpital Necker

    Paris, 75015

  • Hôpital Tenon

    Paris, 75020

  • Hôpital Hôtel Dieu

    Paris, 75181

  • Hôpital Lariboisière

    Paris, 75475

  • Hôpital Saint Louis

    Paris, 75475

  • Hôpital pitié Salpetrière

    Paris, 75651

  • Hôpital Cochin

    Paris, 75674

  • Hôpital Bichat

    Paris, 75877

  • Hôpital Pontchaillou

    Rennes, 35033

  • Hôpital Charles Nicoll

    Rouen, 76031

  • Hôpital Purpan

    Toulouse, 31059

Other trials in France

About this study

Management of participants with low-level persistent viremia

Read the detailed description

ANRS 161 L-Vir is a phase III prospective, randomized, multicenter, open-label, superiority trial for participants with low-level persistent viremia.

Participants will be randomized with a 1:1:1 ratio to the following three arms,

  • Reference arm : counseling without antiretroviral treatment modification
  • Switch arm : switch of current PI/r for Prezista® (darunavir)/ Norvir® (ritonavir) (switch for a drug with a higher genetic barrier) 600/100 mg two times a day (BID) with counseling.
  • Addition of Isentress® (raltégravir) arm : Isentress® (raltegravir) 400 mg two times a day (BID) added to current antiretroviral treatment with counseling
Being tested
Protease inhibitor, Isentress® (raltegravir), Counseling arm
Keywords
HIV-1, antiretroviral treatment, viral load
Medical subject headings
Viremia

What participants receive

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

  • Protease inhibitorDrug

    Also called Prezista® / Norvir®

    Modification in the antiretroviral treatment

    •Switch arm for protease inhibitor : intervention switch of current boosted protease inhibitor for Prezista® (darunavir)/ Norvir® (ritonavir) (switch for a drug with a higher genetic barrier) 600/100 mg two times a day (BID) with counseling.

  • Isentress® (raltegravir)Drug

    • Addition of Isentress® (raltegravir) arm :Isentress® (raltegravir) 400 mg two times a day (BID) added to current antiretroviral treatment with counseling

  • Counseling armOther

    No change of antiretroviral treatment but only counseling

Study groups in NCT02247687
Study groupRoleWhat they receive
Counseling armOtherCounseling without antiretroviral treatment modification
Receives: Other: Counseling arm
Switch arm for protease inhibitorActive comparatorSwitch arm for protease inhibitor : intervention is the switch of current boosted protease inhibitor for Prezista® (darunavir)/ Norvir® (ritonavir) (switch for a drug with a higher genetic barrier) 600/100 mg two times a day (BID) with counseling.
Receives: Drug: Protease inhibitor
Addition of Isentress® (raltegravir)Active comparatorDrug: Addition of Isentress® (raltegravir) arm • Addition of Isentress® (raltegravir) arm :Isentress® (raltegravir) 400 mg two times a day (BID) added to current antiretroviral treatment with counseling
Receives: Drug: Isentress® (raltegravir)

What is being measured

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

  1. Proportion of patients in Virologic success by week 12

    A virologic success is defined by a patient having plasma HIV-1 RNA levels <50 copies/ml at weeks 8 and 12.

    Measured: week 12

Secondary outcomes (12)

  1. Proportion of participants with HIV-1 RNA < 50 copies/ml

    Measured: week 4, week 8, week 12, week 24, week 36, week 48

  2. Proportion of participants with HIV-1 RNA < 20 copies/ml

    Measured: week 4, week 8, week 12, week 24, week 36, week 48

  3. Proportion of participants with HIV-1 RNA <1copy/ml

    Measured: week 8, week 12, week 24, week 36, week 48

  4. Change in CD4 cells count from baseline

    •Change was calculated as the CD4 count at the corresponding week minus the baseline CD4 count

    Measured: week 12, week 24, week 48 and end visit

  5. Number of Participants With Virologic Failure and Emergence of Resistance

    •resistance patterns at failure time compared with day 0, in HIV-DNA and in HIV-RNA

    Measured: day 0 and visit at failure time

  6. Quantification of HIV DNA in peripheral blood mononucleated cell (PBMC)

    Quantification of HIV DNA in PBMC at day 0 and its association with the proportion of success in each arm

    Measured: day 0

  7. Levels of antiretroviral drugs in plasma

    •plasma concentrations of antiretroviral drugs and correlation with success or failure of the strategy

    Measured: day 0 and end visit

  8. Levels of antiretroviral drugs in hair

    •measurement of concentrations of antiretroviral drugs treatments in hair

    Measured: day 0, week 12, week 24and end visit

  9. Levels of HIV-1 RNA in seminal plasma

    quantification of HIV RNA in seminal plasma

    Measured: day 0, week 12, week 48 and end visit

  10. Incidence of Study interruption

    •proportion of participants who discontinued the strategy assigned by randomization at day 0 because of failure

    Measured: From day 0 to week 24

  11. Incidence of clinical and biological adverse events

    • proportions of participants experiencing a clinical or biological adverse events (ANRS scale)

    Measured: from day 0 to week 48

  12. Self-reported adherence

    •self-reported percentage of antiretroviral treatment participant had taken during the last 4 weeks

    Measured: day 0, week 4, week 8, week 12, week 24, week 36, week 48 and end visit

Timeline

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

  1. First posted25 Sep 2014 (estimated)
  2. Study startDec 2014
  3. Primary completionSep 2015
  4. Study completionSep 2015

Why it stopped: Low recruitment of participants for the study

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02247687
Sponsor's protocol ID
ANRS 161 L-Vir
Other IDs
2014-001663-13, 2014
Status last verified
Oct 2015
First submitted
9 Sep 2014
Last updated
12 Oct 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Protease inhibitor, Isentress® (raltegravir) and Counseling arm in people with HIV-1 Infection and Treatment Resistant Disorders, run by ANRS, Emerging Infectious Diseases at 20 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 15 inclusion and 7 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: stopped early, as of the sponsor's last update on 12 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 was stopped early (reason given: Low recruitment of participants for the study). Results are not available in the source record.

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?

Proportion of patients in Virologic success by week 12 (time frame: week 12). 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 NCT02247687.

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 12 Oct 2015.

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