Trial record 13 of 56 for:    " September 09, 2009":" October 09, 2009"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

Maraviroc Plus Darunavir/Ritonavir for Treatment-Naïve Patients Infected With R5-tropic HIV-1 (MIDAS)

This study has been completed.
Sponsor:
Collaborators:
Pfizer
Tibotec, Inc
Information provided by (Responsible Party):
Babafemi Taiwo, Northwestern University
ClinicalTrials.gov Identifier:
NCT00993148
First received: October 8, 2009
Last updated: April 29, 2013
Last verified: April 2013
  Purpose

The objective of this study is to evaluate the safety and efficacy of a novel combination antiretroviral therapy regimen consisting of maraviroc plus darunavir/ritonavir in treatment-naive patients infected with R5-tropic HIV-1. The hypothesis is that in treatment-naive subjects infected with R5-tropic HIV-1, combination antiretroviral therapy with maraviroc plus darunavir/ritonavir is well tolerated and efficacious.


Condition Intervention Phase
HIV-1 Infection
HIV Infections
Drug: maraviroc
Drug: darunavir
Drug: ritonavir
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Maraviroc Plus Darunavir/Ritonavir Study for Treatment-Naïve Patients Infected With R5-tropic HIV-1 Based on Enhanced Sensitivity Trofile

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Proportion of subjects with confirmed plasma HIV-1 RNA > 50 copies/mL [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of subjects with virologic failure or off study treatment regimen (composite end point) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Dynamics of plasma HIV RNA decay measured on Days 7 and 14 in all subjects and additional sampling on days 2, 4, and 10 in a subset of 15 subjects [ Time Frame: Days 2,4,7,10,14 ] [ Designated as safety issue: No ]
  • Proportion of subjects with confirmed plasma HIV-1 RNA > 1000 copies/mL [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Proportion of subjects with confirmed plasma HIV-1 RNA level confirmed >400 copies/mL [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Proportion of subjects with confirmed plasma HIV-1 RNA level confirmed >400 copies/mL [ Time Frame: 48 and 96 weeks ] [ Designated as safety issue: No ]
  • Proportion of subjects with confirmed plasma HIV-1 RNA level >50 copies/mL [ Time Frame: 48 and 96 weeks ] [ Designated as safety issue: No ]
  • Signs/symptoms or laboratory toxicities of Grade 3 or higher, or of any grade which led to a permanent change or discontinuation of study treatment regimen [ Time Frame: Through 48 weeks ] [ Designated as safety issue: Yes ]
  • Drug resistance mutations and co-receptor tropism assessed by Trofile ES [ Time Frame: At study entry and at the time of virologic failure ] [ Designated as safety issue: No ]
  • Evolution of CXCR4 and dual/mixed HIV during the early phase of viral decay [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Drug adherence, assessed as number of missed doses over four-day recall [ Time Frame: Day 14 and weeks 4, 12, 24, and 48 ] [ Designated as safety issue: No ]
  • Trough concentrations (Cmin) of maraviroc and darunavir and associations of these PK parameters with efficacy outcome measures and adherence assessments [ Time Frame: Day 14 and weeks 4, 12, 24, and 48 and at virologic failure ] [ Designated as safety issue: No ]
  • Change in fasting lipids [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Subject-specific changes from baseline (average of pre-entry and entry) in peripheral CD4+ T-cell count [ Time Frame: 48 and 96 weeks ] [ Designated as safety issue: No ]
  • Subject-specific changes from baseline (average of pre-entry and entry) in CD4+ and CD8+ T-cell subsets [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Change in markers of inflammation, immune activation and coagulation [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Enrollment: 25
Study Start Date: May 2010
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: maraviroc
    150 mg tab by mouth once daily for 96 weeks
    Other Name: Selzentry
    Drug: darunavir
    800 mg tab by mouth once daily for 96 weeks
    Other Name: Prezista
    Drug: ritonavir
    100 mg capsule by mouth once daily for 96 weeks
    Other Name: norvir
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HIV-1 infection, as documented by any licensed HIV test kit and confirmed by Western blot, HIV-1 culture, HIV-1 antigen, plasma HIV-1 RNA, or a second antibody test by a method other than ELISA any time prior to study entry
  • Plasma HIV-1 RNA 5, 000 to 500,000 copies/mL obtained within 90 days prior to study entry
  • Exclusive R5 tropism based on enhanced sensitivity Trofile assay done within 90 days prior to entry
  • CD4 cell count > 100 cells/mm3 within 90 days prior to study entry
  • HIV genotype (for RT and protease) performed at any time before study entry (Subjects with single or combination NNRTI or NRTI RAM(s) at screening are permitted)
  • ARV drug-naïve, defined as no previous ARV treatment at any time prior to study entry
  • Negative result from a hepatitis B surface antigen test performed within 90 days prior to study entry
  • Negative result from a hepatitis C antibody test performed within 90 days prior to study entry
  • Laboratory values obtained within 30 days prior to study entry:

    • ANC >=750/mm3
    • Hemoglobin >=10 g/dL
    • Platelets >=50,000/mm3
    • AST (SGOT), ALT (SGPT), and alkaline phosphatase <=5 x ULN
    • Calculated creatinine clearance (CrCl) >=30 mL/min, as estimated by the Cockcroft-Gault equation*
  • Negative serum or urine pregnancy test within 48 hours prior to study entry for women with reproductive potential
  • If participating in sexual activity that could lead to pregnancy, the study subjects with reproductive potential must use one form of contraceptive while receiving protocol-specified medications and for 60 days after stopping the medications.
  • Men and women age >=18 years
  • Ability and willingness of subject or legal guardian/representative to provide informed consent

Exclusion Criteria:

  • Serious illness requiring systemic treatment and/or hospitalization until candidate either completes therapy or is clinically stable on therapy, in the opinion of the site investigator, for at least 7 days prior to study entry
  • Screening HIV genotype obtained any time prior to study entry with any DRV RAM (V11I, V32I, L33F, I47V, I50V, I54L, I54M, T74P, L76V, I84V, and L89V)
  • Treatment within 30 days prior to study entry with immune modulators such as systemic steroids, interleukins, interferons, granulocyte colony-stimulating factor (G-CSF), erythropoietin, or any investigational therapy. NOTE: Subjects receiving stable physiologic glucocorticoid doses (defined as prednisone ≤10 mg/day [or equivalent] as a stable or tapering dose) are permitted. Subjects receiving corticosteroids for acute therapy for PCP or asthma exacerbation, or receiving a short course (defined as ≤2 weeks of pharmacologic glucocorticoid therapy) are permitted
  • Breast-feeding
  • Requirement for any medication that is prohibited with a study medication
  • Known allergy/sensitivity to study drugs or their formulations. A history of sulfa allergy is not an exclusion
  • Active drug or alcohol use or dependence that could interfere with adherence to study requirements
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00993148

Locations
United States, California
Quest Clinical Research
San Francisco, California, United States
United States, Florida
University of Miami
Miami, Florida, United States
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
CORECenter
Chicago, Illinois, United States, 60612
United States, Nebraska
University of Nebraska
Omaha, Nebraska, United States
Sponsors and Collaborators
Northwestern University
Pfizer
Tibotec, Inc
Investigators
Principal Investigator: Babafemi Taiwo, MD Northwestern University
  More Information

No publications provided

Responsible Party: Babafemi Taiwo, Associate Professor, Northwestern University
ClinicalTrials.gov Identifier: NCT00993148     History of Changes
Other Study ID Numbers: MIDAS
Study First Received: October 8, 2009
Last Updated: April 29, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
Treatment naive

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Ritonavir
Darunavir
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014