Clinical Trials

MainTitle

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

This study has been withdrawn
Sponsor
University of Turin, Italy


Information provided by (Responsible Party)
Giovanni Di Perri, University of Turin, Italy

ClinicalTrials.gov Identifier
NCT03708861

First received: October 14, 2018
Last updated: October 14, 2018
Last Verified: October 2018
History of Changes
Purpose

Purpose

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.

Condition Intervention Phase
HIV Infection

Drug : maraviroc (300 mg QD) + atazanavir/ritonavir (300 and 200 mg /100 mg QD)
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pharmacokinetics of Maraviroc and Boosted Atazanavir Dual Regimen in Stable HIV-infected Patients

Further study details as provided by Giovanni Di Perri, University of Turin, Italy:

Primary Outcome Measures

  • maraviroc (300 mg, QD) + atazanavir/ritonavir (200/100 mg, QD) pharmacokinetic evaluation [ Time Frame: within the first 16 weeks after switch ]
    percentage of patients with maraviroc Ctrough>50ng/ml
Secondary Outcome Measures:
  • viral suppression evaluation [ Time Frame: week 60 ]
    percentage of patients with HIV-RNA<20 cp/ml
  • CD4 count evaluation [ Time Frame: week 60 ]
    modification in CD4 count
  • bone density evaluation [ Time Frame: week 60 ]
    modification in bone mineral density (DEXA femur and spine)
  • bone metabolism markers evaluation [ Time Frame: week 60 ]
    modification in bone metabolism markers (bALP and vitamin D, PTH)
  • glomerular and tubular renal function evaluation [ Time Frame: week 60 ]
    modification of proteinuria, glycosuria, phosphaturia and GFR;
  • lipid metabolism markers evaluation [ Time Frame: week 60 ]
    modification in total, HDL, LDL cholesterol and triglycerides
  • bilirubin evaluation [ Time Frame: week 60 ]
    changes in total bilirubin levels

Enrollment: 0
Study Start Date: January 2016
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: 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)
Drug: maraviroc (300 mg QD) + atazanavir/ritonavir (300 and 200 mg /100 mg QD)
  • Phase 1: switch from tenofovir disoproxil fumarato/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)

Other Name:
  • CELSENTRI
  • REYATAZ
  • NORVIR

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.

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

Inclusion Criteria:

  • age>18 years; confirmed HIV-antibodies positivity; signed informed consent; HIV-RNA <20 cp/ml for last 24 months, at least; 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.

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03708861

Locations

Italy
University of Torino
Torino, Italy

Sponsors and Collaborators

University of Turin, Italy
More Information

More Information


Responsible Party: Giovanni Di Perri, Professor, University of Turin, Italy  
ClinicalTrials.gov Identifier: NCT03708861   History of Changes  
Other Study ID Numbers: MARAT  
  2014-004692-22  
Study First Received: October 14, 2018  
Last Updated: October 14, 2018  
Individual Participant Data    
Plan to Share IPD: Undecided  

Keywords provided by Giovanni Di Perri, University of Turin, Italy:

maraviroc, atazanavir/ritonavir

Additional relevant MeSH terms:
HIV Infections
Ritonavir
Atazanavir Sulfate
Maraviroc

ClinicalTrials.gov processed this data on September 16, 2019
This information is provided by ClinicalTrials.gov.