Impact of Raltegravir Intensification on HIV-1-infected Subjects with Complete Viral Suppression under Monotherapy with Protease Inhibitors. A 24-week controlled, open-label, proof-of-concept pilot clinical trial.

Institut de Recerca e la SIDA - IrsiCaixa-0 个研究点开始时间: 2011年10月5日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•1. HIV-1 infected adults (?18 years old).
•2. Absence of prior virological failure with PIs.
•3. No mono or dual protease inhibitor therapy previous to HAART initiation.
•4. Patients had to be on monotherapy with ritonavir-boosted lopinavir (LPV/r 200/50 mg BID) or darunavir (DRV/r 800/100 mg QD) for ? 12 months. Switching from standard HAART to protease inhibitor monotherapy had to happen with undetectable plasma viremia.
•5. Complete virological suppression (<50 copies/mL) for ?12 months, including at least 3 times during the last year.
•6. CD4 cell count ?500 cells/µL.
•7. Availability (if possible, not mandatory) of a genotype prior to the start of HAART, with absence of any drug-related mutations and specifically of any polymorphism or mutation associated to Raltegravir resistance.
•8. Voluntary written informed consent.
•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 40
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1. Lactating, Pregnancy, or fertile women willing to be pregnant.
•2. Active substance abuse or major psychiatric disease.
•3. Presence of any polymorphism or mutation associated to RAL resistance at baseline (prior to first HAART).

发起方

Institut de Recerca e la SIDA - IrsiCaixa-