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

Phase 3

Withdrawn

• Conditions: HIV Infection
• Interventions: Drug: maraviroc (300 mg QD) + atazanavir/ritonavir (300 and 200 mg /100 mg QD)

• Registration Number: NCT03708861
• Lead Sponsor: University of Turin, Italy

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.

Study Timeline

• Study Start: 2016-01
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Study First Submitted: 2018-10-14
• Study First Submitted QC: 2018-10-14
• Study First Posted: 2018-10-17
• Status Verified: 2019-04
• Last Update Submitted: 2020-11-05
• Last Update Posted: 2020-11-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MVC + ATV/r	maraviroc (300 mg QD) + atazanavir/ritonavir (300 and 200 mg /100 mg QD)	maraviroc (300 mg tablet, 300 mg per day every 24 hours) + atazanavir/ritonavir (300 and 200 mg capsule, 300 and 200 mg per day every 24 hours / 100 mg capsule, 100 mg per day every 24 hours)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
viral suppression evaluation	week 60	Number of participants with HIV-RNA\<20 cp/ml
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)
glomerular and tubular renal function evaluation	week 60	Changes in proteinuria, glycosuria, phosphaturia and GFR;
lipid metabolism markers evaluation	week 60	changes in total, HDL, LDL cholesterol and triglycerides
bilirubin evaluation	week 60	changes in total bilirubin levels

Trial Locations

Locations (1)

University of Torino; 🇮🇹 Torino, Italy