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

HIV Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03708861
• Other study ID #: MARAT
• Secondary ID: 2014-004692-22
• Status: Withdrawn
• Phase: Phase 3
• Start date: January 2016
• Est. completion date: December 2017

Study information

• Verified date: April 2019
• Source: University of Turin, Italy
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• HIV Infection
• HIV Infections

Intervention

Drug:
• maraviroc (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)

Locations

Country	Name	City	State
Italy	University of Torino	Torino

Sponsors (1)

Lead Sponsor	Collaborator
University of Turin, Italy

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	maraviroc (300 mg, QD) + atazanavir/ritonavir (200/100 mg, QD) pharmacokinetic evaluation	Number of participants with maraviroc Ctrough>50ng/ml	within the first 16 weeks after switch
Secondary	viral suppression evaluation	Number of participants with HIV-RNA<20 cp/ml	week 60
Secondary	CD4 count evaluation	Changes in CD4+ count	week 60
Secondary	bone density evaluation	Changes in bone mineral density (DEXA femur and spine)	week 60
Secondary	bone metabolism markers evaluation	Changes in bone metabolism markers (bALP and vitamin D, PTH)	week 60
Secondary	glomerular and tubular renal function evaluation	Changes in proteinuria, glycosuria, phosphaturia and GFR;	week 60
Secondary	lipid metabolism markers evaluation	changes in total, HDL, LDL cholesterol and triglycerides	week 60
Secondary	bilirubin evaluation	changes in total bilirubin levels	week 60