The Dolutegravir Antiretroviral Mono-Therapy for HIV Trial - DOMONO

Erasmus MC, Universitair Medisch Centrum Rotterdam0 个研究点目标入组 104 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

暂无简介。

•18 years or older;On cART and HIV-RNA <50 for last >24 weeks;pre-cART: baseline HIVRNA <100.000;pre-cART: CD4 nadir >200;Not on co-medication inducing UGT1A1/CYP3A4 as stated in DTG SPC;General medical condition does not interfere with trial procedures

•Planning to be pregnant;No use of double barrier contraceptive methods;Previous virological failure on any ART.;Patient without documented anti-HBs antibodies.;Subjects positive for hepatitis B at screening (HBsAg+).;Any documented genotypic HIV-1 resistance with at least low-level resistance according to stanford HIV drug resistance database ;No record of the historical baseline plasma viral load available;Subjects with concomitant CDC-C opportunistic infections within 90 days of screening.;Subjects with history of allergy to INI.;Subjects with creatinine clearance <50mL/min according to CKD-EPI.;Subjects with hepatic impairment of at least Child-Pugh B.;Exposure to experimental drug or experimental HIV-1 vaccine within 90 days of start of DTG.;Screening ALT >5x ULN or ALT>3xULN and bilirubin >2 ULN.;Patient (man or woman) planning or hoping to conceive a child/become pregnant during the study;Patients who cannot take DTG 2 hours before or 6 hours after antacids, calciumcarbonate or iron supplements.

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