Evaluation of the efficacy and safety of a switch from cART to dolutegravir monotherapy in HIV
Conditions
Interventions
Trade Name: Tivicay
Pharmaceutical Form: Tablet
Sponsors
Erasmus MC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 18 years or older On cART and HIV-RNA 24 weeks pre-cART: baseline HIVRNA 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
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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy and safety of a switch from cART to dolutegravir monotherapy;Secondary Objective: To evaluate the effect on biochemical markers (renal/liver/lipids), HIV reservoir, BMD, and cost effectiveness. ;Primary end point(s): Difference in percentage of patients who switch to DTG monotherapy as compared to controls on conventional continued cART with HIV-RNA <200 c/mL at week 24 by OT analysis.;Timepoint(s) of evaluation of this end point: Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The time to loss of virological response (TLOVR) defined as the first of two confirmed HIV-RNA >50 c/mL at least 1 week apart. Percentage of patients with virological suppression with HIV-RNA 200 c/mL at any time-point. Difference in change in CD4 cell count at week 48. Changes from baseline to week 24 and 48 in blood-pressure, weight, BMI, fasting serum lipids, Framingham risk score, ATP-III treatment goals, inflammatory markers, renal function, urinalysis, bone mineral density at hip and spine. Cost-effectiveness of DTG monotherapy Viral suppression in HIV-patients on DTG monotherapy with pre-cART CD4 nadir below 200 cells/mm3.;Timepoint(s) of evaluation of this end point: Week 12, week 24 and week 48. | — |
Countries
Netherlands
Contacts
Public ContactCasper Rokx
Erasmus MC
Outcome results
None listed