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

NCT00993148 | Completed Phase 2 Results DMC

• 1 other identifier: MIDAS
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

HIV-1 Infection; HIV Infections

Keywords

Treatment naive

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Plasma HIV-1 RNA >50

  Percentage of participants with confirmed plasma HIV-1 RNA \> 50 copies/mL

  24 weeks

Secondary Outcomes (8)

• Percentage of Participants With Virologic Failure or Off Study Treatment Regimen

  24 weeks

• Percentage of Participants With Plasma HIV-1 RNA >50 Copies/mL

  48 weeks

• Signs/Symptoms or Laboratory Toxicities of Grade 3 or Higher

  96 weeks

• Drug Resistance Mutations and Co-receptor Tropism Assessed by Trofile ES

  At study entry and at the time of virologic failure

• Drug Adherence, Number of Participants With Missed Doses

  Week 24

Study Arms (1)

Maraviroc plus darunavir/ritonavir

EXPERIMENTAL

Single arm open label trial of maraviroc 150 mg plus darunavir/ritonavir 800/100 mg once daily for 96 weeks

Drug: maraviroc; Drug: darunavir; Drug: ritonavir

Interventions

maraviroc DRUG

150 mg tab by mouth once daily for 96 weeks

Also known as: Selzentry

Maraviroc plus darunavir/ritonavir

darunavir DRUG

800 mg tab by mouth once daily for 96 weeks

Also known as: Prezista

Maraviroc plus darunavir/ritonavir

ritonavir DRUG

100 mg capsule by mouth once daily for 96 weeks

Also known as: norvir

Maraviroc plus darunavir/ritonavir

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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
• Active drug or alcohol use or dependence that could interfere with adherence to study requirements

Sponsors & Collaborators

• Northwestern University: lead
• Pfizer: collaborator
• Tibotec, Inc: collaborator

Study Sites (5)

Quest Clinical Research

San Francisco, California, United States

Location

University of Miami

Miami, Florida, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

CORECenter

Chicago, Illinois, 60612, United States

Location

University of Nebraska

Omaha, Nebraska, United States

Location

Related Publications (1)

• Taiwo B, Acosta EP, Ryscavage P, Berzins B, Lu D, Lalezari J, Castro J, Adeyemi O, Kuritzkes DR, Eron JJ, Tsibris A, Swindells S. Virologic response, early HIV-1 decay, and maraviroc pharmacokinetics with the nucleos(t)ide-free regimen of maraviroc plus darunavir/ritonavir in a pilot study. J Acquir Immune Defic Syndr. 2013 Oct 1;64(2):167-73. doi: 10.1097/QAI.0b013e3182a03d95.

  PMID: 23797691 RESULT

MeSH Terms

Conditions

HIV Infections

Interventions

Maraviroc; Darunavir; 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; Sulfonamides; Amides; Carbamates; Acids, Acyclic; Carboxylic Acids; Sulfones; Sulfur Compounds; Furans; Thiazoles

Results Point of Contact

• Title: Dr. Babafemi Taiwo
• Organization: Northwestern University

b-taiwo@northwestern.edu

312-695-5085

Study Officials

• Babafemi Taiwo, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 8, 2009
• First Posted: October 12, 2009
• Study Start: May 1, 2010
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: September 5, 2014
• Results First Posted: August 19, 2014

Record last verified: 2014-08

Locations

US (5)