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

NCT02247687 | Terminated Phase 3 DMC

• 2 other identifiers: ANRS 161 L-Vir2014-001663-13
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 20

Brief Summary

Management of participants with low-level persistent viremia

Conditions

HIV-1 Infection; Treatment Resistant Disorders; Viremia

Keywords

HIV-1; antiretroviral treatment; viral load

Outcome Measures

Primary Outcomes (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.

  week 12

Secondary Outcomes (12)

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

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

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

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

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

  week 8, week 12, week 24, week 36, week 48

• Change in CD4 cells count from baseline

  week 12, week 24, week 48 and end visit

• Number of Participants With Virologic Failure and Emergence of Resistance

  day 0 and visit at failure time

Study Arms (3)

Counseling arm

OTHER

Counseling without antiretroviral treatment modification

Other: Counseling arm

Switch arm for protease inhibitor

ACTIVE COMPARATOR

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

Addition of Isentress® (raltegravir)

ACTIVE COMPARATOR

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)

Interventions

Protease inhibitor DRUG

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.

Also known as: Prezista® / Norvir®

Switch arm for protease inhibitor

Isentress® (raltegravir) DRUG

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

Addition of Isentress® (raltegravir)

Counseling arm OTHER

No change of antiretroviral treatment but only counseling

Counseling arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• \<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)

You may not qualify if:

• HIV-2 infection,
• 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 ...)

Sponsors & Collaborators

• ANRS, Emerging Infectious Diseases: lead
• Janssen-Cilag Ltd.: collaborator

Study Sites (20)

Hôpital Avicenne

Bobigny, 93000, France

Location

Hôpital Jean Verdier

Bondy, 93143, France

Location

Hôpital Saint André

Bordeaux, 33075, France

Location

Hôpital Pellegrin

Bordeaux, 33076, France

Location

Hôpital de la côte de Nacre

Caen, 14033, France

Location

Hôpital Henry Mondor

Créteil, 94010, France

Location

Hôpital Européen Georges Pompidou

France, 75674, France

Location

Hôpital de Bicêtre

Le Kremlin-Bicêtre, 94275, France

Location

Hôpital de l'Hôtel Dieu

Nantes, 44093, France

Location

Hôpital Necker

Paris, 75015, France

Location

Hôpital Tenon

Paris, 75020, France

Location

Hôpital Hôtel Dieu

Paris, 75181, France

Location

Hôpital Lariboisière

Paris, 75475, France

Location

Hôpital Saint Louis

Paris, 75475, France

Location

Hôpital pitié Salpetrière

Paris, 75651, France

Location

Hôpital Cochin

Paris, 75674, France

Location

Hôpital Bichat

Paris, 75877, France

Location

Hôpital Pontchaillou

Rennes, 35033, France

Location

Hôpital Charles Nicoll

Rouen, 76031, France

Location

Hôpital Purpan

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Viremia

Interventions

Protease Inhibitors; Darunavir; Ritonavir; Raltegravir Potassium

Condition Hierarchy (Ancestors)

Virus Diseases; Infections; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Sulfonamides; Amides; Organic Chemicals; Carbamates; Acids, Acyclic; Carboxylic Acids; Sulfones; Sulfur Compounds; Furans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Thiazoles; Azoles; Pyrrolidinones; Pyrrolidines

Study Officials

• Jade Ghosn, MD, PhD

  APHP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2014
• First Posted: September 25, 2014
• Study Start: December 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: October 12, 2015

Record last verified: 2015-10

Locations

FR (20)