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 个研究点目标入组 73 人开始时间: 2009年7月14日最近更新: 2022年1月4日

适应症

试验速览

暂无简介。

•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:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 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.

发起方

Fundació Lluita contra la SIDA