Overview

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

Status:
Terminated
Trial end date:
2015-09-01
Target enrollment:
0
Participant gender:
All
Summary
Management of participants with low-level persistent viremia
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
ANRS, Emerging Infectious Diseases
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Collaborator:
Janssen-Cilag Ltd.
Treatments:
Darunavir
HIV Protease Inhibitors
Protease Inhibitors
Raltegravir Potassium
Ritonavir
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 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 ...)