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Lopinavir/r or Fosamprenavir/r Switch to Atazanavir/r or Darunavir/r (LARD)
This study is currently recruiting participants.
Verified by Community Research Initiative of New England, April 2009
First Received: September 18, 2008   Last Updated: April 3, 2009   History of Changes
Sponsors and Collaborators: Community Research Initiative of New England
Tibotec Pharmaceutical Limited
Information provided by: Community Research Initiative of New England
ClinicalTrials.gov Identifier: NCT00756730
  Purpose

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.


Condition Intervention Phase
HIV Infections
Drug: atazanavir/ritonavir
Drug: darunavir/ritonavir
Phase IV

MedlinePlus related topics: AIDS
Drug Information available for: Ritonavir Lopinavir BMS 232632 Darunavir Fosamprenavir Fosamprenavir sodium Fosamprenavir calcium Atazanavir sulfate Darunavir ethanolate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Parallel Assignment
Official Title: Randomized, Open-Label Study of Switch From Lopinavir/Ritonavir (LPV/r) or Fosamprenavir/Ritonavir (FPV/r) to Either Once Daily Atazanavir/Ritonavir (ATV/r) or Once Daily Darunavir/Ritonavir (DRV/r) (Plus Background Nucleoside Reverse Transcriptase Inhibitors) in Patients Experiencing Triglyceride Elevations While Receiving LPV/r or FPV/r.

Further study details as provided by Community Research Initiative of New England:

Primary Outcome Measures:
  • The change in fasting triglyceride level from baseline to week 24

Secondary Outcome Measures:
  • The proportion of patients with fasting triglycerides <200mg/dL at week 24
  • Fasting lipid profiles (total, LDL, and HDL cholesterol and triglycerides) in the two study groups at weeks 4, 12, 24
  • Change in lipid profiles at week 4, compared to baseline
  • Proportion of patients in each arm with VL<50 copies/mL at weeks 12 and 24
  • Proportion of patients with HIV VL <200 copies/mL at week 24
  • Symptoms distress and patient quality of life self assessment at weeks 4, 12 and 24
  • Incidence of grade 2-4 adverse events possibly related to study drug
  • Proportion of subjects who discontinue study due to adverse events prior to week 24
  • Adherence as measured by the M-MASRI adherence scale at each study visit
  • CD4 cell count responses in each group at week 24

Estimated Enrollment: 88
Study Start Date: September 2008
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Active Comparator Drug: atazanavir/ritonavir
2.: Active Comparator Drug: darunavir/ritonavir

Detailed Description:

This Phase IV trial will look at lipid and virologic responses after a switch to a more lipid-friendly antiretroviral regimen. Participants will be randomized to receive either boosted atazanavir or boosted darunavir given once daily, along with background NRTIs. This 24-week study will require 4 visits after randomization for evaluation, monitoring, and lab studies.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Currently receiving an ART regimen including LPV/r or FPV/r and > or equal to 2 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 HIV viral load (<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 atazanir
  • CDC Class C Illness diagnosed within 30 days of screening
  • Patient is currently receiving the following HMGCoA reductase inhibitor medications (statins): pravastatin, lovastatin, simvastatin
  • Patient is currently receiving a bile acid sequestrant (cholestyramine, colestipol, and colesvelam)
  • Grade 3 or 4 Laboratory abnormalities as defined by a standardized grading scheme based on the DAIDS table (see Appendix B) with the following exceptions:

    1. Pre-existing diabetes mellitus with asymptomatic, nonfasting glucose grade 3 elevations
    2. Subjects with asymoptomatic 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00756730

Contacts
Contact: Anne Habel, BS 617-502-1712 ahabel@crine.org

Locations
United States, Arizona
Spectrum Medical Group Recruiting
Phoenix, Arizona, United States, 85012
Contact: Thanes Vanig, MD     602-604-9500     thanesvanig@spectrummedgroup.com    
Principal Investigator: Thanes Vanig, MD            
United States, California
AIDS Healthcare Foundation Recruiting
Los Angeles, California, United States, 02319
Contact: Cordova Robert, RN     323-913-1033     robert.cordova@aidshealth.org    
Principal Investigator: Homayoon Khanlou, MD            
United States, District of Columbia
Whitman-Walker Clinic Recruiting
Washington D.C., District of Columbia, United States, 20009
Contact: Desire'e Dickerson     202-745-6111     ddickerson@wwc.org    
Principal Investigator: Richard Elion, MD            
United States, Florida
Orlando Immunology Center Recruiting
Orlando, Florida, United States, 32803
Contact: Millie Lopez     407-647-3960 ext 2105     mlopez@oicorlando.com    
Principal Investigator: Edwin DeJesus, MD            
United States, Massachusetts
Community Research Initiative Recruiting
Boston, Massachusetts, United States, 02215
Contact: Karen McLaughlin, BN     617-502-1725     kmclaughlin@crine.org    
Principal Investigator: Hannah Olivet, MD            
Community Research Initiative - West Recruiting
Springfield, Massachusetts, United States, 01107
Contact: Betzy Arroyo     413-723-2264     barroyo@crine.org    
Principal Investigator: Daniel Skiest, MD            
United States, Minnesota
Abbott Northwestern Infectious Disease and Travel Clinic Recruiting
Minneapolis, Minnesota, United States, 55404
Contact: Deb Woods     612-863-7046     deborah.wood@allina.com    
Principal Investigator: Frank Rhame, MD            
United States, New York
AIDS Community Health Center Recruiting
Rochester, New York, United States, 14804
Contact: Donna Carlson     585-244-9000     dcarlson@achcrochester.org    
Principal Investigator: Roberto Corales, DO            
United States, Pennsylvania
Philadelphia Fight Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Angela Kapalko     215-985-4448 ext 126     akapalko@fight.org    
Principal Investigator: Karam Mounzer, MD            
United States, Texas
David M. Lee, M.D., P.A., a/b/a Uptown Physicians Group Recruiting
Dallas, Texas, United States, 75204
Contact: M Scott Batson     214-303-1033     scottb@uptownphysiciansgroup.com    
Principal Investigator: Mark Tribble, MD            
Nicholaos C. Bellos, MD, PA Recruiting
Dallas, Texas, United States, 75204
Contact: L. Peter Krzykowski     214- 828-4702 ext 107     pkryzkowski@drbellos.com    
Principal Investigator: Nicholaos C. Bellos, MD, PA            
Sponsors and Collaborators
Community Research Initiative of New England
Tibotec Pharmaceutical Limited
Investigators
Principal Investigator: Daniel J Skiest, MD Community Research Initiative
  More Information

No publications provided

Study ID Numbers: 08-09
Study First Received: September 18, 2008
Last Updated: April 3, 2009
ClinicalTrials.gov Identifier: NCT00756730     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Community Research Initiative of New England:
lopinavir
ritonavir
atazanavir
fosamprenavir
darunavir
anti-retroviral
AIDS
HIV
LARD
triglyceride
protease inhibitors
treatment Experienced

Study placed in the following topic categories:
HIV Protease Inhibitors
Sexually Transmitted Diseases, Viral
Anti-HIV Agents
Acquired Immunodeficiency Syndrome
Atazanavir
Antiviral Agents
Immunologic Deficiency Syndromes
Darunavir
Protease Inhibitors
Reverse Transcriptase Inhibitors
Virus Diseases
Anti-Retroviral Agents
Lopinavir
Fosamprenavir
HIV Infections
Ritonavir
Sexually Transmitted Diseases
Retroviridae Infections

Additional relevant MeSH terms:
Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Infection
Darunavir
Reverse Transcriptase Inhibitors
Lopinavir
Anti-Retroviral Agents
Therapeutic Uses
Retroviridae Infections
Nucleic Acid Synthesis Inhibitors
HIV Protease Inhibitors
RNA Virus Infections
Anti-HIV Agents
Immune System Diseases
Acquired Immunodeficiency Syndrome
Atazanavir
Enzyme Inhibitors
Antiviral Agents
Immunologic Deficiency Syndromes
Pharmacologic Actions
Protease Inhibitors
Virus Diseases
Fosamprenavir
HIV Infections
Ritonavir
Sexually Transmitted Diseases
Lentivirus Infections

ClinicalTrials.gov processed this record on May 07, 2009