HIV Infection
Conditions
Keywords
maraviroc, atazanavir, ritonavir
Brief summary
The purpose of this study is to describe pharmacokinetics of maraviroc (MVC) 300 mg and atazanavir/ritonavir (ATV/r) 200/100 mg QD in HIV-infected stable patients.
Detailed description
The rational of this study is to save therapeutic options, toxicity and costs. The available literature shows that antiretroviral regimens that do not include a nucleoside backbone of tenofovir resulted in less bone and kidney toxicity. Atazanavir dosing 200/100 mg qd represents a simplification strategy correlated with virologic efficacy and a reduction of parameters toxicity associated. Maraviroc is suggested as a possible drug associated to PI/r in dual therapies. Even in this case, the available evidence supports the choice of the dosage of 300 mg/day.
Interventions
DRUGmaraviroc (300 mg QD) + atazanavir/ritonavir (300 and 200 mg /100 mg QD)
Phase 1: switch from tenofovir disoproxil fumarate/emtricitabine (200/245 mg QD)+ atazanavir/ritonavir (300 /100 mg QD) to maraviroc (300 mg QD) + atazanavir/ritonavir (300 /100 mg QD). Phase 2: switch from maraviroc (300 mg QD) + atazanavir/ritonavir (300 /100 mg QD) to maraviroc (300 mg QD) + atazanavir/ritonavir (200 /100 mg QD)
Sponsors
University of Turin, Italy
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* age\>18 years; * confirmed HIV-antibodies positivity; * signed informed consent; * HIV-RNA \<20 cp/ml for the last 24 months; * no virological failures to PI regimens; * no major PI resistance associated mutations; * genotypic tropism for CCR5 co-receptor.
Exclusion criteria
* active opportunistic infections or neoplasms; * need for drugs with known drug-drug interactions with included drugs; * liver cirrhosis; * any evidence of tropism for CXCR4 or dual infection; * pregnancy; * self-reported adherence\<90%; * HBsAg positivity; * detectable HCV RNA.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| maraviroc (300 mg, QD) + atazanavir/ritonavir (200/100 mg, QD) pharmacokinetic evaluation | within the first 16 weeks after switch | Number of participants with maraviroc Ctrough\>50ng/ml |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CD4 count evaluation | week 60 | Changes in CD4+ count |
| bone density evaluation | week 60 | Changes in bone mineral density (DEXA femur and spine) |
| bone metabolism markers evaluation | week 60 | Changes in bone metabolism markers (bALP and vitamin D, PTH) |
| viral suppression evaluation | week 60 | Number of participants with HIV-RNA\<20 cp/ml |
| lipid metabolism markers evaluation | week 60 | changes in total, HDL, LDL cholesterol and triglycerides |
| bilirubin evaluation | week 60 | changes in total bilirubin levels |
| glomerular and tubular renal function evaluation | week 60 | Changes in proteinuria, glycosuria, phosphaturia and GFR; |
Countries
Italy
Outcome results
None listed