Pharmacokinetics of Maraviroc and Boosted Atazanavir Dual Regimen in Stable HIV-infected Patients

University of Turin, Italy

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Conditions

HIV Infection

Interventions

maraviroc (300 mg QD) + atazanavir/ritonavir (300 and 200 mg /100 mg QD)DRUG

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)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

University of Torino

Torino, Italy

Outcomes

Primary Outcomes

maraviroc (300 mg, QD) + atazanavir/ritonavir (200/100 mg, QD) pharmacokinetic evaluation

Number of participants with maraviroc Ctrough\>50ng/ml

Time frame: within the first 16 weeks after switch

Secondary Outcomes

viral suppression evaluation

Number of participants with HIV-RNA\<20 cp/ml

Time frame: week 60

CD4 count evaluation

Changes in CD4+ count

Time frame: week 60

bone density evaluation

Changes in bone mineral density (DEXA femur and spine)

Time frame: week 60

bone metabolism markers evaluation

Changes in bone metabolism markers (bALP and vitamin D, PTH)

Time frame: week 60

glomerular and tubular renal function evaluation

Changes in proteinuria, glycosuria, phosphaturia and GFR;

Time frame: week 60

lipid metabolism markers evaluation

changes in total, HDL, LDL cholesterol and triglycerides

Time frame: week 60

bilirubin evaluation

changes in total bilirubin levels

Time frame: week 60

Data from ClinicalTrials.gov

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