maraviroc plus darunavir/ritonavir for treatment-naïve patients infected with r5-tropic hiv-1

Conditions: HIV-1 Infection; HIV Infections

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

Keywords: treatment naive