A Study to Compare Brachial Artery Reactivity and Cardiovascular Risk of a Treatment Simplification by Darunavir/Ritonavir (DRV/r) 800/100 mg Versus a Triple Combination Therapy Containing DRV/r in HIV-1 Infected Patients
Condition: Human Immunodeficiency Virus 1
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections; Immunologic Deficiency Syndromes
Intervention: Darunavir(DRV); Ritonavir; 2 nucleoside reverse transcriptase inhibitors (NRTIs)
Intervention description: Oral administration of tablet DRV 800 mg (2 tablets of 400 mg) once daily at the same time, within 30 minutes after food for 48 weeks; Oral administration of tablet ritonavir 100 mg once daily at the same time, within 30 minutes after food for 48 weeks; 2 NRTIs will be administered as per the package inserts.
Intervention MeSH terms: Ritonavir; Darunavir; Reverse Transcriptase Inhibitors
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Human immunodeficiency virus 1; Acquired immunodeficiency syndrome; Immunologic deficiency syndrome; Darunavir/ritonavir; Darunavir; Ritonavir; Nucleoside reverse transcriptase inhibitors (NRTIs); Prezista

Summary:

      The purpose of this study is to compare change of brachial artery flow mediated
      vasodilatation using Darunavir/Ritonavir (DRV/r) 800/100 mg once daily as a monotherapy (use
      of a single medication) versus a triple combination therapy containing 2 nucleoside reverse
      transcriptase inhibitors (NRTIs) and DRV/r in Human immunodeficiency virus-1 (HIV-1) infected
      participants.
    

Eligibility criteria:

        Inclusion Criteria: - Human immunodeficiency virus-1 (HIV-1) infected participants on their
        first-line treatment with highly active antiretroviral therapy (HAART) (combination of 2 or
        3 nucleoside reverse transcriptase inhibitors [NRTIs] with at least 1 additional
        antiretroviral [ARV] from the non-nucleoside reverse transcriptase inhibitor [NNRTI] and/or
        protease inhibitors [PI] class) for at least 24 weeks, provided the same ARV combination
        for at least 8 weeks before screening

          -  Participants' preference for a more convenient regimen and/or any current or history
             of toxicity on actual regimen

          -  Plasma HIV-1 ribonucleic acid (RNA) less than 50 cp/ml for at least 24 weeks before
             screening, where single viral blips of more than 50 copies/mL are allowed

          -  Cluster of differentiation 4 (CD4) count more than 100/mm3 at the start of HAART and
             more than 200/mm3 at screening

          -  Healthy on the basis of physical examination, medical history, vital signs, clinical
             laboratory tests, and 12-lead electrocardiogram performed at screening

          -  Agrees to protocol-defined use of effective contraception

          -  Postmenopausal, surgically sterile, or abstinent female participants

        Exclusion Criteria:

          -  History of coronary heart disease, uncontrolled hypertension, peripheral vascular
             disease and or cerebrovascular disease

          -  History of virological failure on highly active antiretroviral therapy, plasma HIV-1
             ribonucleic acid more than 500 copies/mL after initial full virological suppression
             while on ARV therapy and any PI mutations

          -  Participants with significantly hepatic and liver insufficiency or diagnosed with
             acute viral hepatitis or have active clinically significant diseases and acquired
             immune deficiency syndrome (AIDS) defining illness at screening

          -  Current significant tobacco use, active drug or alcohol use or dependence

          -  Use of lipid-lowering drugs within 4 weeks prior to study entry and use of
             testosterone, anabolic steroids, oral contraceptives or hormonal replacement within 12
             weeks prior to study entry or previous or current use of darunavir

          -  Use of systemic glucocorticoids, long-acting inhaled steroids (inhaled via mouth or
             nose), or other immunomodulators within 30 days prior to study entry