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

ANRS, Emerging Infectious Diseases

Status and phase: Terminated; Phase 3

Conditions: Treatment Resistant Disorders; HIV-1 Infection; Viremia

Treatments: Drug: Isentress® (raltegravir); Drug: Protease inhibitor; Other: Counseling arm

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02247687

ANRS 161 L-Vir

2014-001663-13 (EudraCT Number)

Details and patient eligibility

About

Management of participants with low-level persistent viremia

Full 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

Enrollment: 4 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 ...)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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4 participants in 3 patient groups

Counseling arm

Other group

Description:

Counseling without antiretroviral treatment modification

Treatment:

Other: Counseling arm

Switch arm for protease inhibitor

Active Comparator group

Description:

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.

Treatment:

Drug: Protease inhibitor

Addition of Isentress® (raltegravir)

Active Comparator group

Description:

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

Treatment:

Drug: Isentress® (raltegravir)