Lopinavir/r or Fosamprenavir/r Switch to Atazanavir/r or Darunavir/r
Condition: HIV Infections
MeSH terms: HIV Infections
Intervention: ATV/r; DRV/r
Intervention description: Switch to ATV/r at a dose of 300mg/100mg QD for 24 weeks. Subjects will continue to maintain their background NRTI drugs throughout the screening period and during the entire study.; We designed a study to determine if switching virologically suppressed patients on a regimen containing LPV/r or FPV/r to either DRV/r or ATV/r would result in improved TGs while maintaining virological suppression. Switch to DRV/r at a dose 800mg/100mg QD for 24 weeks. Subjects will continue to maintain their background NRTI drugs throughout the screening period and during the entire study.
Intervention MeSH terms: Atazanavir Sulfate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 49.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: lopinavir; ritonavir; atazanavir; fosamprenavir; darunavir; anti-retroviral; AIDS; HIV; LARD; triglyceride; protease inhibitors; treatment Experienced

Summary:

      For participants with HIV taking either lopinavir or fosamprenavir who have elevated
      triglycerides, this trial will study the change in triglycerides after switching protease
      inhibitors.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Currently receiving Antiretroviral Therapy (ART) regimen including LPV/r or FPV/r and
             > or equal to 2 Nucleoside Reverse Transcriptase Inhibitors (NRTIs). Patient must be
             on a stable regimen containing LPV/r or FPV/r for at least 12 weeks prior to
             screening.

          -  Documentation of an undetectable Human Immunodeficiency Virus (HIV) viral load (VL<400
             copies/ml) using an FDA approved assay for a minimum of twelve weeks prior to
             screening AND undetectable HIV viral load using an FDA approved ultrasensitive assay
             at screening.

          -  No evidence of HIV protease resistance as defined by the Stanford HIV database

          -  Currently receiving first protease inhibitor unless switch to LPV/r or FPV/r was for
             non-virologic reasons

          -  Fasting triglycerides > 200 mg/dL

          -  No ongoing issues that in the opinion of the investigator would lead to decreased
             ability to comply with the study procedures

          -  If currently receiving a proton pump inhibitor, the dose is < omeprazole 20 mg or the
             equivalent dose of another proton pump inhibitor

          -  If patient is receiving another lipid lowering medication, it must be at a stable dose

        Exclusion Criteria:

          -  Currently receiving an ART regimen other than > or equal to two NRTIs and either LPV/r
             or FPV/r

          -  Prior use of darunavir or atazanavir

          -  CDC Class C Illness diagnosed within 30 days of screening

          -  Patient is currently receiving the following Hydroxamethylglutaryl-coA (HMGCoA)
             reductase inhibitor medications (statins): pravastatin, lovastatin, simvastatin

          -  Patient is currently receiving a bile acid sequestrant (cholestyramine, colestipol,
             and colesevelam)

          -  Grade 3 or 4 Laboratory abnormalities as defined by a standardized grading scheme
             based on the DAIDS table with the following exceptions:

               1. Pre-existing diabetes mellitus with asymptomatic, nonfasting glucose grade 3
                  elevations

               2. Subjects with asymptomatic grade 3 fasting triglyceride or cholesterol elevations

          -  Clinical or laboratory evidence of clinically significant liver impairment/dysfunction
             disease or cirrhosis

          -  Note: Individuals co-infected with chronic hepatitis B or C viruses will be allowed to
             enter the trial if their condition is clinically stable and they will not require
             therapy during the course of the study. Individuals diagnosed with acute viral
             hepatitis at screening will not be allowed to enroll during acute phase

          -  Active substance abuse or significant psychiatric illness that in the opinion of the
             investigator might interfere with study compliance

          -  Use of any investigational agents 30 days prior to screening

          -  Life expectancy < 6 months in the opinion of the investigator

          -  Pregnancy or breast feeding

          -  Female subject of childbearing potential (i.e., heterosexually active, and not
             surgically sterile or at least two years post-menopausal) not using effective
             non-hormonal birth control methods or not willing to continue practicing these birth
             control methods from screening until the last trial related activity