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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02247687
Recruitment Status : Terminated (Low recruitment of participants for the study)
First Posted : September 25, 2014
Last Update Posted : October 12, 2015
Sponsor:
Collaborator:
Janssen-Cilag Ltd.
Information provided by (Responsible Party):
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)

Brief Summary:
Management of participants with low-level persistent viremia

Condition or disease Intervention/treatment Phase
HIV-1 Infection Treatment Resistant Disorders Viremia Drug: Protease inhibitor Drug: Isentress® (raltegravir) Other: Counseling arm Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Management of Participants With Low-level Persistent Viremia (ANRS 161 L-VIR)
Study Start Date : December 2014
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Raltegravir

Arm Intervention/treatment
Counseling arm
Counseling without antiretroviral treatment modification
Other: Counseling arm
No change of antiretroviral treatment but only counseling

Active Comparator: Switch arm for protease inhibitor
Switch 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.
Drug: Protease inhibitor

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.

Other Name: Prezista® / Norvir®

Active Comparator: Addition of Isentress® (raltegravir)

Drug: 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

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




Primary Outcome Measures :
  1. Proportion of patients in Virologic success by week 12 [ Time Frame: week 12 ]
    A virologic success is defined by a patient having plasma HIV-1 RNA levels <50 copies/ml at weeks 8 and 12.


Secondary Outcome Measures :
  1. Proportion of participants with HIV-1 RNA < 50 copies/ml [ Time Frame: week 4, week 8, week 12, week 24, week 36, week 48 ]
  2. Proportion of participants with HIV-1 RNA < 20 copies/ml [ Time Frame: week 4, week 8, week 12, week 24, week 36, week 48 ]
  3. Proportion of participants with HIV-1 RNA <1copy/ml [ Time Frame: week 8, week 12, week 24, week 36, week 48 ]
  4. Change in CD4 cells count from baseline [ Time Frame: week 12, week 24, week 48 and end visit ]
    •Change was calculated as the CD4 count at the corresponding week minus the baseline CD4 count

  5. Number of Participants With Virologic Failure and Emergence of Resistance [ Time Frame: day 0 and visit at failure time ]
    •resistance patterns at failure time compared with day 0, in HIV-DNA and in HIV-RNA

  6. Quantification of HIV DNA in peripheral blood mononucleated cell (PBMC) [ Time Frame: day 0 ]
    Quantification of HIV DNA in PBMC at day 0 and its association with the proportion of success in each arm

  7. Levels of antiretroviral drugs in plasma [ Time Frame: day 0 and end visit ]
    •plasma concentrations of antiretroviral drugs and correlation with success or failure of the strategy

  8. Levels of antiretroviral drugs in hair [ Time Frame: day 0, week 12, week 24and end visit ]
    •measurement of concentrations of antiretroviral drugs treatments in hair

  9. Levels of HIV-1 RNA in seminal plasma [ Time Frame: day 0, week 12, week 48 and end visit ]
    quantification of HIV RNA in seminal plasma

  10. Incidence of Study interruption [ Time Frame: From day 0 to week 24 ]
    •proportion of participants who discontinued the strategy assigned by randomization at day 0 because of failure

  11. Incidence of clinical and biological adverse events [ Time Frame: from day 0 to week 48 ]
    • proportions of participants experiencing a clinical or biological adverse events (ANRS scale)

  12. Self-reported adherence [ Time Frame: day 0, week 4, week 8, week 12, week 24, week 36, week 48 and end visit ]
    •self-reported percentage of antiretroviral treatment participant had taken during the last 4 weeks



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.
  • 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)

Exclusion Criteria:

  • 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 ...)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02247687


Locations
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Sponsors and Collaborators
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Janssen-Cilag Ltd.
Investigators
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Principal Investigator: Jade Ghosn, MD, PhD APHP

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Responsible Party: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
ClinicalTrials.gov Identifier: NCT02247687    
Other Study ID Numbers: ANRS 161 L-Vir
2014‐001663‐13 ( EudraCT Number )
First Posted: September 25, 2014    Key Record Dates
Last Update Posted: October 12, 2015
Last Verified: October 2015
Keywords provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):
HIV-1
antiretroviral treatment
viral load
Additional relevant MeSH terms:
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Viremia
Virus Diseases
Sepsis
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Anti-Retroviral Agents
Raltegravir Potassium
Ritonavir
Darunavir
HIV Protease Inhibitors
Protease Inhibitors
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents
HIV Integrase Inhibitors
Integrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors