A randomised controlled trial in human immunodeficiency virus (HIV) positive patients comparing the efficacy of lopinavir/ritonavir monotherapy versus conventional triple therapy

Vrije University Medical Centre (VUMC) (The Netherlands)0 个研究点目标入组 240 人开始时间: 2006年1月27日最近更新: 2015年1月13日

试验速览

暂无简介。

•1. Subject is HIV-1-infected
•2. Subject is on a first or second line antiretroviral therapy consisting of either one protease inhibitor (PI) or one non-nucleoside reverse transcriptase inhibitors (NNRTI) and at least two nucleoside reverse transcriptase inhibitors (NRTIs)
•3. Subject has a HIV-1 ribonucleic acid (RNA) load less than 50 copies/ml for at least three months
•4. Ethylenediaminetetraacetic acid (EDTA) plasma from before initiation of first or second line antiretroviral therapy is available for genotyping
•5. Subject is at least 18 and not older than 65 years of age
•6. Subject is able and willing to sign the informed consent form prior to screening evaluations

•1. Any mutation in the protease at codon 32, 46, 47, 48, 50, 54, 82, 84 or 90 or more than two mutations in the protease at codon 10, 20, 24, 33, 53, 63, 71, 73
•2. Any protease inhibitor regimen failure
•3. Any of the following mutations in the reverse transcriptase: M41L, D67N, K70R, L210W, T215Y or T215F, K219Q, K219E, or K65R
•4. History of sensitivity/idiosyncrasy to lopinavir/ritonavir
•5. Relevant history or current condition that might interfere with drug absorption, distribution, metabolism or excretion
•6. Inability to understand the nature and extent of the trial and the procedures required
•7. Pregnant female (as confirmed by a human chorionic gonadotropin [HCG] test performed less than three weeks before the first dose) or breast-feeding female
•8. Hepatitis B surface antigen (HBsAg) positive hepatitis B infection
•9. Abnormal serum liver enzymes or creatinine, determined as levels being greater than three times upper limit of normal
•10. Fasting plasma triglyceride level greater than 3.0 mmol/l (= 265.8 mg/dl) in non-Kaletra containing regimens despite the use of lipid lowering drugs
•11. Fasting plasma total cholesterol level greater than 6.2 mmol/l (= 239.9 mg/dl) in non-Kaletra containing regimens despite the use of lipid lowering drugs
•12. Concomitant use of medications that interfere with lopinavir pharmacokinetics

发起方

Vrije University Medical Centre (VUMC) (The Netherlands)