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

• Status: Completed
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the non-inferiority in the efficacy of DRV/r (900/100 mg) monotherapy at 48 weeks versus LPV/r (400/100 mg) as simplification strategy in subjects with sustained viral suppression on stable PI or NNRTI-antiretroviral regimens.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Germans Trias i Pujol Hospital
• Treatments: Darunavir; Lopinavir; Ritonavir

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.