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.
Name: maraviroc
Description: 150 mg tab by mouth once daily for 96 weeksType: DrugMaraviroc plus darunavir/ritonavir
Name: darunavir
Description: 800 mg tab by mouth once daily for 96 weeksType: DrugMaraviroc plus darunavir/ritonavir
Name: ritonavir
Description: 100 mg capsule by mouth once daily for 96 weeksType: DrugMaraviroc plus darunavir/ritonavir
Description: Percentage of participants with confirmed plasma HIV-1 RNA > 50 copies/mL
Measure: Percentage of Participants With Plasma HIV-1 RNA >50 Time: 24 weeksDescription: Percentage of participants with virologic failure (confirmed plasma HIV-1 RNA > 50 copies/mL) or off study treatment regimen (composite end point)
Measure: Percentage of Participants With Virologic Failure or Off Study Treatment Regimen Time: 24 weeksDescription: Percentage of participants with confirmed plasma HIV-1 RNA level >50 copies/mL
Measure: Percentage of Participants With Plasma HIV-1 RNA >50 Copies/mL Time: 48 weeksDescription: 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
Measure: Signs/Symptoms or Laboratory Toxicities of Grade 3 or Higher Time: 96 weeksDescription: Drug adherence, assessed as number of participants with missed doses over four-day recall
Measure: Drug Adherence, Number of Participants With Missed Doses Time: Week 24Description: Average trough concentration (Ctrough) of maraviroc
Measure: Trough Concentrations (Ctrough) of Maraviroc Time: 24 hoursDescription: Median changes from baseline in peripheral CD4+ T-cell count
Measure: Median CD4 Count Change From Baseline Time: 96 weeksDescription: Proportion of participants with confirmed plasma HIV-1 RNA level >50 copies/mL
Measure: Proportion of Participants With Plasma HIV-1 RNA >50 Copies/mL Time: 96 weeksSingle Group Assignment
There are 11 SNPs
- 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. --- V11I --- --- V32I --- --- L33F --- --- I47V ---
- 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. --- V11I --- --- V32I --- --- L33F --- --- I47V --- --- I50V ---
- 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. --- V11I --- --- V32I --- --- L33F --- --- I47V --- --- I50V --- --- I54L ---
- 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. --- V11I --- --- V32I --- --- L33F --- --- I47V --- --- I50V --- --- I54L --- --- I54M ---
- 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. --- V11I --- --- V32I --- --- L33F --- --- I47V --- --- I50V --- --- I54L --- --- I54M --- --- T74P --- --- L76V --- --- I84V ---
- 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. --- V11I --- --- V32I --- --- L33F ---
- 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. --- V11I --- --- V32I --- --- L33F --- --- I47V --- --- I50V --- --- I54L --- --- I54M --- --- T74P --- --- L76V ---
- 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. --- V11I --- --- V32I --- --- L33F --- --- I47V --- --- I50V --- --- I54L --- --- I54M --- --- T74P --- --- L76V --- --- I84V --- --- L89V ---
- 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. --- V11I --- --- V32I --- --- L33F --- --- I47V --- --- I50V --- --- I54L --- --- I54M --- --- T74P ---
- 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. --- V11I ---
- 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. --- V11I --- --- V32I ---