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

NCT03708861 | Withdrawn Phase 3

• 2 other identifiers: MARAT2014-004692-22
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infection

Keywords

maraviroc; atazanavir; ritonavir

Outcome Measures

Primary Outcomes (1)

• maraviroc (300 mg, QD) + atazanavir/ritonavir (200/100 mg, QD) pharmacokinetic evaluation

  Number of participants with maraviroc Ctrough\>50ng/ml

  within the first 16 weeks after switch

Secondary Outcomes (7)

• viral suppression evaluation

  week 60

• CD4 count evaluation

  week 60

• bone density evaluation

  week 60

• bone metabolism markers evaluation

  week 60

• glomerular and tubular renal function evaluation

  week 60

Study Arms (1)

MVC + ATV/r

EXPERIMENTAL

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)

Interventions

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

Also known as: CELSENTRI, REYATAZ, NORVIR

MVC + ATV/r

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Turin, Italy: lead

Study Sites (1)

University of Torino

Torino, Italy

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Maraviroc; Atazanavir Sulfate; Ritonavir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyridines; Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins; Thiazoles; Sulfur Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 14, 2018
• First Posted: October 17, 2018
• Study Start: January 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: November 6, 2020

Record last verified: 2019-04

Locations

IT (1)