Maraviroc Plus Darunavir/Ritonavir for Treatment-Naïve Patients Infected With R5-tropic HIV-1
Condition: HIV-1 Infection; HIV Infections
MeSH terms: Infections; Communicable Diseases
Intervention: maraviroc; darunavir; ritonavir
Intervention description: 150 mg tab by mouth once daily for 96 weeks; 800 mg tab by mouth once daily for 96 weeks; 100 mg capsule by mouth once daily for 96 weeks
Intervention MeSH terms: Ritonavir; Darunavir; Maraviroc
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Treatment naive

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.
    

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