Maraviroc Plus Darunavir/Ritonavir for Treatment-Naïve Patients Infected With R5-tropic HIV-1
- Conditions
- HIV-1 InfectionHIV Infections
- Interventions
- Registration Number
- NCT00993148
- Lead Sponsor
- Northwestern University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
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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
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Plasma HIV-1 RNA 5, 000 to 500,000 copies/mL obtained within 90 days prior to study entry
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Exclusive R5 tropism based on enhanced sensitivity Trofile assay done within 90 days prior to entry
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CD4 cell count > 100 cells/mm3 within 90 days prior to study entry
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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)
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ARV drug-naïve, defined as no previous ARV treatment at any time prior to study entry
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Negative result from a hepatitis B surface antigen test performed within 90 days prior to study entry
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Negative result from a hepatitis C antibody test performed within 90 days prior to study entry
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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*
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Negative serum or urine pregnancy test within 48 hours prior to study entry for women with reproductive potential
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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.
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Men and women age >=18 years
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Ability and willingness of subject or legal guardian/representative to provide informed consent
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Maraviroc plus darunavir/ritonavir darunavir Single arm open label trial of maraviroc 150 mg plus darunavir/ritonavir 800/100 mg once daily for 96 weeks Maraviroc plus darunavir/ritonavir maraviroc Single arm open label trial of maraviroc 150 mg plus darunavir/ritonavir 800/100 mg once daily for 96 weeks Maraviroc plus darunavir/ritonavir ritonavir Single arm open label trial of maraviroc 150 mg plus darunavir/ritonavir 800/100 mg once daily for 96 weeks
- Primary Outcome Measures
Name Time Method Percentage of Participants With Plasma HIV-1 RNA >50 24 weeks Percentage of participants with confirmed plasma HIV-1 RNA \> 50 copies/mL
- Secondary Outcome Measures
Name Time Method Percentage of Participants With Virologic Failure or Off Study Treatment Regimen 24 weeks Percentage of participants with virologic failure (confirmed plasma HIV-1 RNA \> 50 copies/mL) or off study treatment regimen (composite end point)
Percentage of Participants With Plasma HIV-1 RNA >50 Copies/mL 48 weeks Percentage of participants with confirmed plasma HIV-1 RNA level \>50 copies/mL
Signs/Symptoms or Laboratory Toxicities of Grade 3 or Higher 96 weeks 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
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 Drug adherence, assessed as number of participants with missed doses over four-day recall
Trough Concentrations (Ctrough) of Maraviroc 24 hours Average trough concentration (Ctrough) of maraviroc
Median CD4 Count Change From Baseline 96 weeks Median changes from baseline in peripheral CD4+ T-cell count
Proportion of Participants With Plasma HIV-1 RNA >50 Copies/mL 96 weeks Proportion of participants with confirmed plasma HIV-1 RNA level \>50 copies/mL
Trial Locations
- Locations (5)
University of Miami
🇺🇸Miami, Florida, United States
Quest Clinical Research
🇺🇸San Francisco, California, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
CORECenter
🇺🇸Chicago, Illinois, United States
University of Nebraska
🇺🇸Omaha, Nebraska, United States