RANDOMISED AND PROSPECTIVE CLINICAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF LOPINAVIR/RITONAVIR MONOTHERAPY VS DARUNAVIR/RITONAVIR MONOTHERAPIES AS SIMPLIFICATION SWITCHING STRATEGIES OF PI/NNRTI-TRIPLE THERAPY BASED-REGIMENS.

Fundació Lluita contra la SIDA0 sites73 target enrollmentJuly 14, 2009

Overview

No summary available.

Registry

who.int

Start Date

July 14, 2009

End Date

October 25, 2012

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Fundació Lluita contra la SIDA

•1\.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) or 1 NNRTI (nevirapine or efavirenz.)
•2\.Undetectable plasma HIV\-1 RNA (VL \< 50 copies/mL) while on HAART during at least 3 month prior to switching.
•3\.Nadir CD4 cell count \> 100 cells/mm3\.
•4\.Absence of major PI\-resistance mutations in HIV\-protease (IAS 2008\).20
•5\.Good treatment adherence.
•6\.Voluntary written informed consent.
•7\.Patients and physician's preference to change the current HAART regimen for reasons of simplification and/or toxicity.
•Are the trial subjects under 18? no
•Number of subjects for this age range:

•1\.History of virological failure to a previous antiretroviral protease\-containing regimens.
•2\.History of virological failure defined as two consecutive plasma HIV\-1 RNA \> 50 copies/mL while on current antiretroviral therapy
•3\.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
•4\.Pregnancy or fertile women willing to be pregnant.
•5\.Patients co\-infected with hepatitis B.
•6\.Concomitant use of any drug with potential drug\-drug interaction with DRV/r or LPV/r at study entry.
•7\.Therapies including interferon, interleukin\-2, cytotoxic chemotherapy or immunosuppressors at study entry.