A randomised controlled trial in HIV positive patients comparing the efficacy of lopinavir/ritonavir monotherapy versus conventional triple therapy.

VU Medical CenterandUniversity Medical Center Utrecht0 个研究点目标入组 240 人开始时间: 待定最近更新: 2024年2月28日

适应症

试验速览

•1. Subject is HIV-1-infected;
•2. Subject is on a first or second line antiretroviral therapy consisting of either 1 PI or 1 NNRTI and at least 2 NRTI;
•3. Subject has a HIV-1 RNA load < 50 copies/ml for at least 3 months;
•4. 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 2 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 an HCG test performed less than 3 weeks before the first dose) or breast-feeding female;
•8. HBsAg positive hepatitis B infection;
•9. Abnormal serum liver enzymes or creatinine, determined as levels being > 3 times upper limit of normal;
•10. Fasting plasma triglyceride level > 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 > 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

VU Medical CenterandUniversity Medical Center Utrecht