Status:
COMPLETED
Maraviroc Plus Darunavir/Ritonavir for Treatment-Naïve Patients Infected With R5-tropic HIV-1
Lead Sponsor:
Northwestern University
Collaborating Sponsors:
Pfizer
Tibotec, Inc
Conditions:
HIV-1 Infection
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 in...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00993148
Start Date
May 1 2010
End Date
April 1 2013
Last Update
September 5 2014
Active Locations (5)
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1
Quest Clinical Research
San Francisco, California, United States
2
University of Miami
Miami, Florida, United States
3
Northwestern University
Chicago, Illinois, United States, 60611
4
CORECenter
Chicago, Illinois, United States, 60612