The Dolutegravir Antiretroviral Mono-Therapy for HIV Trial - DOMONO

Erasmus MC0 个研究点目标入组 134 人开始时间: 2015年2月16日最近更新: 2017年5月22日

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 (unless measured during acute HIV)
•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
•A secondary objective is to test viralogical suppression in patients with a pre-cART CD4 count nadir of below 200
•cells/mm3. For this N=30 pilot study, the same inclusioncriteria as mentioned above will apply, except for the CD4
•count nadir pre-cART =200 cells/mm3 inclusion criterium. The 30 patients for this pilot study will need to have a
•pre-cART CD4 count BELOW 200 cells/mm3 with a CD4 count >350 cells/mm3 at the time of the screening visit.
•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 120
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 14

•Planning to be pregnant
•No use of double barrier contraceptive methods
•Previous virological failure on any ART.
•Patient without documented anti-HBs antibodies prior to vaccination, and unwilling to undergo vaccination against hepatitis B.
•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.
•For the N=30 pilot study, the same exclusion criteria as mentiioned above will apply.

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