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

NCT ID: NCT00993148

Last Updated: 2014-09-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2013-04-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Maraviroc plus darunavir/ritonavir

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

Group Type: EXPERIMENTAL

maraviroc

Intervention Type: DRUG

150 mg tab by mouth once daily for 96 weeks

darunavir

Intervention Type: DRUG

800 mg tab by mouth once daily for 96 weeks

ritonavir

Intervention Type: DRUG

100 mg capsule by mouth once daily for 96 weeks

Interventions

maraviroc

150 mg tab by mouth once daily for 96 weeks

Intervention Type: DRUG

darunavir

800 mg tab by mouth once daily for 96 weeks

Intervention Type: DRUG

ritonavir

100 mg capsule by mouth once daily for 96 weeks

Intervention Type: DRUG

Other Intervention Names

Selzentry; Prezista; norvir

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: collaborator

Tibotec, Inc

INDUSTRY

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Babafemi Taiwo

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Babafemi Taiwo, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

Quest Clinical Research

San Francisco, California, United States

University of Miami

Miami, Florida, United States

Northwestern University

Chicago, Illinois, United States

CORECenter

Chicago, Illinois, United States

University of Nebraska

Omaha, Nebraska, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 23797691 (View on PubMed)

Other Identifiers

MIDAS

Identifier Type: -

Identifier Source: org_study_id