De Dolutegravir Antiretroviral Mono-Therapy for HIV Trial

Phase 1

• Conditions: Evaluation of the efficacy and safety of a switch from cART to dolutegravir monotherapy in HIV; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2014-005454-19-NL
• Lead Sponsor: Erasmus MC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02-16
• Last Update Posted: 22 May 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 134

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified