Viral suppression in Cerebrospinal Fluid in HIV-1 infected patients receiving Ritonavir-boosted Atazanavir plus lamivudine dual theraphy. SCALA study

Dr. Daniel Podzamczer Palter. Hospital Univesitari de Bellvitge. Unidad de VIH.0 个研究点目标入组 10 人开始时间: 2014年3月3日最近更新: 2019年2月28日

适应症

试验速览

暂无简介。

•1. HIV-1 infected men = 18 years of age.
•2. Chronic HIV-1 infection
•3. Be on a stable ART consisting of tenofovir/emtricitabine plus ritonavir-boosted atazanavir, continously for at least 1 month before the screening visit.
•4. HIV-1 RNA <40 c/mL for at least 6 months before the Screening visit.
•5. Signed and dated written informed consent prior to inclusion.
•6. Subjects must agree to utilize a highly effective method of contraception during heterosexual intercourse from the screening visit throught the duration of the study.
•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 10
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1. Severe hepatic insufficiency (Child-Pugh Class C)
•2. Chronic infection with hepatitis B virus (HBV)
•2. Ongoing malignancy
•3. Active opportunistic infection
•.4. Primary resistance to any of the ARV included in the study (genotypes without evidence of lamivudine resistance (mutation M184V/I) and mutations protease inhibitors resistance-associated mutations (IAS USA list) or history of virologic failure with risk of resistance selection to any of the study drugs.
•5. Any verified Grade 4 laboratory abnormality.
•6. ALT or AST = 3xULN and/or bilirubin = 1.5xULN.

发起方

Dr. Daniel Podzamczer Palter. Hospital Univesitari de Bellvitge. Unidad de VIH.