Switching From Protease Inhibitor (PI) to Etravirine in HIV-1 Infected Subjects With Viremia Suppression
HIV
About this trial
This is an interventional treatment trial for HIV focused on measuring Active Comparator, Placebo Comparator, Sham Comparator, No intervention, Other, Treatment Experienced
Eligibility Criteria
Inclusion Criteria:
- Adult patient having a diagnosis of HIV-1 infection.
- Antiretroviral therapy started at least 12 months before, always with a HAART combination including 2 NRTIs plus a PI.
- Maintained undetectable plasma HIV-1 RNA (VL < 50 copies/mL) since the beginning of antiretroviral therapy, for at least 6 months.
- Absence of suspected or documented resistance mutations in the RT associated to NNRTIs or to any NRTI.
Patient having at least one of the following conditions:
- Dyslipemia (LDL cholesterol >130 mg/dL or triglycerides > 350 mg/dL) derived from their current PI regimen or current use of lipid-lowering agents due to dyslipemia,
- Antiretroviral-related gastrointestinal disturbances, or
- Low patient's satisfaction associated with the current regimen posology (BID regimen, ritonavir use, ritonavir intolerance…).
- Good treatment adherence.
- Voluntary written informed consent.
Exclusion Criteria:
- Previous therapy with mono or dual antiretroviral therapies after initial of HAART era.
- Previous antiretroviral treatment failures, treatment interruptions (A) or blips (B) in viral load (VL > 50 copies/mL).
- Acute infections or uncontrolled chronic infection in the 2 months previous to the inclusion.
- Pregnancy or fertile women willing to be pregnant.
- Clinically significant malabsorption syndrome within 30 days prior to randomization.
(A) Patients who in the past made any interruption of treatment (provide that it has not been in the last year) may be considered candidates for the study, if they meet other criteria for inclusion, since the break in the treatment should not assume the emergence of mutations.
(B) Small blips that are preceded or forwarded by 2 undetectable viral loads will not be taken in care.
Sites / Locations
- Germans Trias i Pujol University Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Etravirine group
Control group
To switch from the PI to Etravirine 400 mg dissolved in water every 24 hours
Continue with the same antiretroviral regimen