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

NCT ID: NCT03708861

Last Updated: 2020-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2017-12-31

Brief Summary

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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

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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.

Conditions

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HIV Infection

Keywords

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maraviroc atazanavir ritonavir

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MVC + ATV/r

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)

Group Type EXPERIMENTAL

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

Intervention Type 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)

Interventions

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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)

Intervention Type DRUG

Other Intervention Names

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CELSENTRI REYATAZ NORVIR

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Turin, Italy

OTHER

Sponsor Role lead

Responsible Party

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Giovanni Di Perri

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Torino

Torino, , Italy

Site Status

Countries

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Italy

Other Identifiers

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2014-004692-22

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MARAT

Identifier Type: -

Identifier Source: org_study_id