Management of Participants With Low-level Persistent Viremia (ANRS 161 L-VIR)
NCT ID: NCT02247687
Last Updated: 2015-10-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
4 participants
INTERVENTIONAL
2014-12-31
2015-09-30
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Counseling arm
Counseling without antiretroviral treatment modification
Counseling arm
No change of antiretroviral treatment but only counseling
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.
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.
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
Isentress® (raltegravir)
• Addition of Isentress® (raltegravir) arm :Isentress® (raltegravir) 400 mg two times a day (BID) added to current antiretroviral treatment with counseling
Interventions
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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.
Isentress® (raltegravir)
• Addition of Isentress® (raltegravir) arm :Isentress® (raltegravir) 400 mg two times a day (BID) added to current antiretroviral treatment with counseling
Counseling arm
No change of antiretroviral treatment but only counseling
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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 ...)
18 Years
ALL
No
Sponsors
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Janssen-Cilag Ltd.
INDUSTRY
ANRS, Emerging Infectious Diseases
OTHER_GOV
Responsible Party
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Principal Investigators
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Jade Ghosn, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
APHP
Locations
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Hôpital Avicenne
Bobigny, , France
Hôpital Jean Verdier
Bondy, , France
Hôpital Saint André
Bordeaux, , France
Hôpital Pellegrin
Bordeaux, , France
Hôpital de la côte de Nacre
Caen, , France
Hôpital Henry Mondor
Créteil, , France
Hôpital Européen Georges Pompidou
France, , France
Hôpital de Bicêtre
Le Kremlin-Bicêtre, , France
Hôpital de l'Hôtel Dieu
Nantes, , France
Hôpital Necker
Paris, , France
Hôpital Tenon
Paris, , France
Hôpital Hôtel Dieu
Paris, , France
Hôpital Lariboisière
Paris, , France
Hôpital Saint Louis
Paris, , France
Hôpital pitié Salpetrière
Paris, , France
Hôpital Cochin
Paris, , France
Hôpital Bichat
Paris, , France
Hôpital Pontchaillou
Rennes, , France
Hôpital Charles Nicoll
Rouen, , France
Hôpital Purpan
Toulouse, , France
Countries
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Other Identifiers
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2014-001663-13
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ANRS 161 L-Vir
Identifier Type: -
Identifier Source: org_study_id
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