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

Primary Purpose

HIV Infection

Status
Withdrawn
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
maraviroc (300 mg QD) + atazanavir/ritonavir (300 and 200 mg /100 mg QD)
Sponsored by
University of Turin, Italy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infection focused on measuring maraviroc, atazanavir, ritonavir

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • University of Torino

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MVC + ATV/r

Arm 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)

Outcomes

Primary Outcome Measures

maraviroc (300 mg, QD) + atazanavir/ritonavir (200/100 mg, QD) pharmacokinetic evaluation
Number of participants with maraviroc Ctrough>50ng/ml

Secondary Outcome Measures

viral suppression evaluation
Number of participants with HIV-RNA<20 cp/ml
CD4 count evaluation
Changes in CD4+ count
bone density evaluation
Changes in bone mineral density (DEXA femur and spine)
bone metabolism markers evaluation
Changes in bone metabolism markers (bALP and vitamin D, PTH)
glomerular and tubular renal function evaluation
Changes in proteinuria, glycosuria, phosphaturia and GFR;
lipid metabolism markers evaluation
changes in total, HDL, LDL cholesterol and triglycerides
bilirubin evaluation
changes in total bilirubin levels

Full Information

First Posted
October 14, 2018
Last Updated
November 5, 2020
Sponsor
University of Turin, Italy
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1. Study Identification

Unique Protocol Identification Number
NCT03708861
Brief Title
Pharmacokinetics of Maraviroc and Boosted Atazanavir Dual Regimen in Stable HIV-infected Patients
Official Title
Pharmacokinetics of Maraviroc and Boosted Atazanavir Dual Regimen in Stable HIV-infected Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Withdrawn
Study Start Date
January 2016 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Turin, Italy

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infection
Keywords
maraviroc, atazanavir, ritonavir

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MVC + ATV/r
Arm Type
Experimental
Arm 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)
Intervention Type
Drug
Intervention Name(s)
maraviroc (300 mg QD) + atazanavir/ritonavir (300 and 200 mg /100 mg QD)
Other Intervention Name(s)
CELSENTRI, REYATAZ, NORVIR
Intervention Description
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)
Primary Outcome Measure Information:
Title
maraviroc (300 mg, QD) + atazanavir/ritonavir (200/100 mg, QD) pharmacokinetic evaluation
Description
Number of participants with maraviroc Ctrough>50ng/ml
Time Frame
within the first 16 weeks after switch
Secondary Outcome Measure Information:
Title
viral suppression evaluation
Description
Number of participants with HIV-RNA<20 cp/ml
Time Frame
week 60
Title
CD4 count evaluation
Description
Changes in CD4+ count
Time Frame
week 60
Title
bone density evaluation
Description
Changes in bone mineral density (DEXA femur and spine)
Time Frame
week 60
Title
bone metabolism markers evaluation
Description
Changes in bone metabolism markers (bALP and vitamin D, PTH)
Time Frame
week 60
Title
glomerular and tubular renal function evaluation
Description
Changes in proteinuria, glycosuria, phosphaturia and GFR;
Time Frame
week 60
Title
lipid metabolism markers evaluation
Description
changes in total, HDL, LDL cholesterol and triglycerides
Time Frame
week 60
Title
bilirubin evaluation
Description
changes in total bilirubin levels
Time Frame
week 60

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
University of Torino
City
Torino
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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