HIV MedDRA version: 17.1 Level: LLT Classification code 10068341 Term: HIV-1 infection System Organ Class: 100000004862
Conditions
Interventions
Trade Name: Tivicay
Pharmaceutical Form: Tablet
Trade Name: Reyataz
Pharmaceutical Form: Capsule
Trade Name: lamivudine
Pharmaceutical Form: Tablet
Sponsors
Radboud University Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. HIV-infected as documented by positive HIV antibody test and confirmed by Western Blot. 2. Subject is in need for a switch in maintenance regimen due to adverse effects, toxicities, simplification and/or resistance. 3. Subject is at least 18 years of age at the day of screening. 4. Subject is able and willing to sign the Informed Consent Form prior to screening evaluations. 5. HIV-1 RNA =65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: 1. Documented history of sensitivity/idiosyncrasy to medicinal products or excipients. 2. Relevant history or current condition that might interfere with drug absorption, distribution, me-tabolism or excretion. 3. Inability to understand the nature and extent of the trial and the procedures required. 4. Pregnant female (as confirmed by an HCG test performed less than 3 weeks before the first dose) or breast-feeding female. 5. Abnormal serum transaminases determined as levels being > 5 times upper limit of normal (see Appendix A for normal ranges of clinical laboratory values). 6. Renal failure determined as an estimated Glomerular Filtration Rate (eGFR) < 50 ml/min (MDRD-based). 7. Concomitant use of medications that interfere with atazanavir, dolutegravir or lamivudine pharma-cokinetics: oxcarbamazepine, phenytoin, phenobarbital, carbamazepine, St. John’s wort, rifam-picin, clarithromycin, H2 receptor antagonists, proton pump inhibitors, irinotecan, midazolam, triazolam, co-trimoxazole, other antiretroviral drugs. 8. Concomitant use of medications that are contraindicated for use with atazanavir, dolutegravir or lamivudine: alfuzosin, dofetilide, quetiapine, kinidine, bepridil, simvastatin, atorvastatin, lovastatin, sildenafil (as for use in pulmonary arterial hypertension), cladribine. 9. Active hepatobiliary or hepatic disease (including chronic hepatitis B or C infection). 10. Alcohol abuse.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the pharmacokinetics of the alternative maintenance QD regimen combining atazanavir, dolutegravir and lamivudine in HIV infected patients. ;Secondary Objective: To asses short term efficacy of the combination of atazanavir, dolutegravir and lamivudine as maintenance regimen in HIV infected patients. To evaluate the safety and tolerability of the combination of atazanavir, dolutegravir and lamivudine as maintenance regimen in HIV infected patients. ;Primary end point(s): Geometric Mean and the 95% classical confidence interval of AUC0-24h, Cmax and C24h for atazanavir and dolutegravir. Median (range) of tmax for atazanavir and dolutegravir. Values will be compared to historical data. Individual and mean plasma concentrations will be presented. Overlay presentations will be given to illustrate inter-subject variability. Descriptive statistics will be calculated for the plasma concentrations at each sampling time. ;Timepoint(s) of evaluation of this end point: At week 4 a pharmacokinetic (PK) curve will be recorded for atazanavir and dolutegravir at the following time points: t=0 (pre-dose), 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0 and 24.0 hours post ingestion. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): HIV-1 RNA and CD4 count will be tabulated per time point. The HIV-1 RNA < 40 copies per mL will be tabulated into a frequency table. Geometric Mean and the 95% classical confidence interval of CD4 count will be calculated and change from baseline will be presented. Adverse events and serious adverse events will be listed and the incidence (number of subjects with at least one AE) will be presented. Special attention will be given to subjects who discontinued be-cause of AEs. ;Timepoint(s) of evaluation of this end point: Screening, week 4 and week 12. Safety assessment on every study visit. | — |
Countries
Netherlands
Contacts
Public ContactDavid Burger
Radboud University Medical Center
Outcome results
None listed