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

University of Turin

Status and phase: Withdrawn; Phase 3

Conditions: HIV Infection

Treatments: Drug: maraviroc (300 mg QD) + atazanavir/ritonavir (300 and 200 mg /100 mg QD)

Study type: Interventional

Funder types: Other

Identifiers

NCT03708861

2014-004692-22 (EudraCT Number)

MARAT

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

MVC + ATV/r

Experimental group

Description:

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)

Treatment:

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