Changes in Triglyceride and Other Lipids (Levels of Fats Found in Blood) When Taking Darunavir Compared to Atazanavir in HIV-infected Patients That Have Never Received Treatment
Condition: HIV
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this research study is to compare changes in triglyceride and other lipids
      (levels of fats found in the blood) from Baseline (Day 1) to Week 12 for darunavir/ritonavir
      800/100 mg once daily versus atazanavir/ritonavir 300/100 mg once daily in combination with a
      fixed-dose background regimen consisting of emtricitabine [FTC]/tenofovir [TDF] 200/300 mg
      once daily). This study will also evaluate the safety (adverse events), effectiveness, and
      tolerability of darunavir/ritonavir and atazanivir/ritonavir over 48 weeks.
    

Detailed description: 
      The purpose of this study is to expand our understanding of the metabolic effects of
      darunavir/ritonavir (DRV/r) in HIV-infected patients. This is a phase 4, multicenter,
      open-label, randomized (study drug assigned by chance), comparative study designed to compare
      changes in lipid, glucose, and insulin parameters in HIV-infected, anti-retroviral (ARV)
      naive patients treated with DRV/r 800/100 mg once daily (QD) versus atazanavir/ritonavir
      (ATV/r) 300/100 mg QD in combination with a common background of emtricitabine (FTC)/
      tenofovir (TDF) 200/300 mg QD. In addition, changes in inflammatory markers will be measured.
      A substudy of the parent study TMC114HIV4023 will evaluate insulin sensitivity and
      endothelial function in a subset of patients. The study will be conducted at approximately 16
      study sites in the United States. Approximately 60 HIV-1 infected, treatment-naive adult
      patients will be enrolled in the study. Screening will take place during a 4-week period. At
      the baseline visit, eligible patients will be randomized in a 1:1 ratio to receive DRV/r
      800/100 mg QD or ATV/r 300/100 mg QD administered in combination with a fixed-dose background
      regimen consisting of emtricitabine (FTC)/tenofovir (TDF) 200/300 mg once daily. The
      treatment period is 48 weeks. Study assessments will be performed at clinic visits at the end
      of weeks 4, 8, 12, 24, 36, and 48. The primary endpoint will be assessed at week 12. All
      patients will return for follow up visits 1 week and 4 weeks after the completion of study
      treatment. During the treatment period, the patient will be seen at regular visits during
      which the investigator will assess the patient's medical condition, any Adverse Events and
      study drug compliance. Laboratory evaluations for efficacy and safety will be done at regular
      visits as well as blood pressure monitoring. Up to twenty patients (evenly randomized to
      receive DRV/r or ATV/r) who meet additional entry criteria will be enrolled in the substudy.
      The study hypothesis is the change in triglycerides and other lipids from baseline to week 12
      will be similar in the DRV/r arm versus the ATV/r arm. The substudy hypothesis is that DRV/r
      will not adversely affect insulin sensitivity or endothelial function during 12 weeks of
      therapy, and the change from baseline in insulin sensitivity and endothelial function will be
      similar in the DRV/r arm versus the ATV/r arm. During the treatment period, the patient will
      be seen at regular visits during which the investigator will assess the patient's medical
      condition, any Adverse Events and study drug compliance. Laboratory evaluations for efficacy
      and safety will be done at regular visits as well as blood pressure monitoring. Patients will
      be randomized in a 1:1 ratio to receive darunavir/ritonavir 800/100 mg once daily (QD) plus
      emtricitabine (FTC)/tenofovir (TDF) 200/300 mg QD or atazanavir/ritonavir 300/100 mg QD plus
      emtricitabine (FTC)/tenofovir (TDF) for 48 weeks.
    

Intervention name(s): ritonavir; ritonavir; darunavir; emtricitabine [FTC]/tenofovir [TDF]; emtricitabine [FTC]/tenofovir [TDF]; atazanavir
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 100 mg capsule or tablet once daily for 48 weeks; 100 mg capsule or tablet once daily for 48 weeks; 800 mg tablet once daily for 48 weeks; 200/300 mg tablet once daily for 48 weeks; 200/300 mg once daily for 48 weeks; 300 mg capsule once daily for 48 weeks
Intervention MeSH terms: Ritonavir; Atazanavir Sulfate; Darunavir; Tenofovir; Emtricitabine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HIV; AIDS; Immunodeficiency Virus, Human; PREZISTA; darunavir; TMC114; Protease Inhibitor; Truvada; Atazanavir; REYATAZ; HIV Infections; Treatment Naïve