Clinical Study to Evaluate the Efficacy and Safety of Lopinavir/Ritonavir Monotherapy Versus Darunavir/Ritonavir Monotherapies as Simplification Switching Strategies of PI/NNRTI-Triple Therapy Based-Regimens
HIV Infections
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Darunavir, Lopinavir, Monotherapy, Antiretroviral simplification strategy, HIV, Treatment experienced
Eligibility Criteria
Inclusion Criteria:
- HIV-1 infected adults (=/+18 years old).
Patients having a diagnosis of HIV infection, on stable HAART including:
2 NRTI/NtRTIs plus one of the following : 1 PI/ritonavir (lopinavir/ritonavir, atazanavir/ritonavir, fosamprenavir /ritonavir, tipranavir/ritonavir, darunavir/ritonavir) or ATV/unboosted (in a regimen without tenofovir) 1 NNRTI (nevirapine or efavirenz), raltegravir or maraviroc
- Undetectable plasma HIV-1 RNA (VL < 50 copies/mL) while on HAART during at least 3 month prior to switching.
- Nadir CD4 cell count > 100 cells/mm3.
- Absence of major PI-resistance mutations in HIV-protease (IAS 2008).20 Good treatment adherence.
- Voluntary written informed consent.
- Patients and physician's preference to change the current HAART regimen for reasons of simplification and/or toxicity.
Exclusion Criteria:
- History of virological failure to a previous antiretroviral protease-containing regimens.
- History of virological failure defined as two consecutive plasma HIV-1 RNA > 50 copies/mL while on current antiretroviral therapy
- Acute infections or uncontrolled chronic infection in the 2 months previous to the inclusion or physical examination that, in the investigator's opinion, would compromise the patient's safety or outcome of the study
- Breastfeeding, pregnancy or fertile women willing to be pregnant.
- Patients co-infected with hepatitis B.
- Concomitant use of any drug with potential drug-drug interaction with DRV/r or LPV/r at study entry.
- Therapies including interferon, interleukin-2, cytotoxic chemotherapy or immunosuppressors at study entry.
Sites / Locations
- Germans Trias i Pujol Hospital
- Hospital Universitario de Canarias
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Darunavir/ritonavir
Lopinavir/ritonavir
to switch from the triple therapy based regimens to Darunavir/ritonavir
to switch from the triple therapy based regimens to Lopinavir/ritonavir