Status:
TERMINATED
Management of Participants With Low-level Persistent Viremia (ANRS 161 L-VIR)
Lead Sponsor:
ANRS, Emerging Infectious Diseases
Collaborating Sponsors:
Janssen-Cilag Ltd.
Conditions:
HIV-1 Infection
Treatment Resistant Disorders
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Management of participants with low-level persistent viremia
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 rati...
Eligibility Criteria
Inclusion
- 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
- 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 ...)
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT02247687
Start Date
December 1 2014
End Date
September 1 2015
Last Update
October 12 2015
Active Locations (20)
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1
Hôpital Avicenne
Bobigny, France, 93000
2
Hôpital Jean Verdier
Bondy, France, 93143
3
Hôpital Saint André
Bordeaux, France, 33075
4
Hôpital Pellegrin
Bordeaux, France, 33076