Management of Participants With Low-level Persistent Viremia (ANRS 161 L-VIR)
HIV-1 Infection, Treatment Resistant Disorders, Viremia
About this trial
This is an interventional treatment trial for HIV-1 Infection focused on measuring HIV-1, antiretroviral treatment, viral load
Eligibility 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 <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 ...)
Sites / Locations
- Hôpital Avicenne
- Hôpital Jean Verdier
- Hôpital Saint André
- Hôpital Pellegrin
- Hôpital de la côte de Nacre
- Hôpital Henry Mondor
- Hôpital Européen Georges Pompidou
- Hôpital de Bicêtre
- Hôpital de l'Hôtel Dieu
- Hôpital Necker
- Hôpital Tenon
- Hôpital Hôtel Dieu
- Hôpital Lariboisière
- Hôpital Saint Louis
- Hôpital pitié Salpetrière
- Hôpital Cochin
- Hôpital Bichat
- Hôpital Pontchaillou
- Hôpital Charles Nicoll
- Hôpital Purpan
Arms of the Study
Arm 1
Arm 2
Arm 3
Other
Active Comparator
Active Comparator
Counseling arm
Switch arm for protease inhibitor
Addition of Isentress® (raltegravir)
Counseling without antiretroviral treatment modification
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: 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