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Sponsors and Collaborators: |
Community Research Initiative of New England Tibotec Pharmaceutical Limited |
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Information provided by: | Community Research Initiative of New England |
ClinicalTrials.gov Identifier: | NCT00756730 |
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 |
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. |
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 |
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1: Active Comparator | Drug: atazanavir/ritonavir |
2.: Active Comparator | Drug: darunavir/ritonavir |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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:
Individuals diagnosed with acute viral hepatitis at screening will not be allowed to enroll during acute phase
Contact: Jodi Jensen, RN | 617.502.1716 | jjensen@crine.org |
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, 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: Denise Hayes 214-828-4702 dhayes@drbellos.com | |
Principal Investigator: Nicholaos C. Bellos, MD, PA | |
United States, Wisconsin | |
Medical College of Wisconsin | Recruiting |
Milwaukee, Wisconsin, United States, 53226 | |
Contact: Mandy Kastner 414-805-0737 mkastner@mcw.edu | |
Principal Investigator: Andrew Petroll, MD |
Principal Investigator: | Daniel J Skiest, MD | Community Research Initiative |
Study ID Numbers: | 08-09 |
Study First Received: | September 18, 2008 |
Last Updated: | June 23, 2009 |
ClinicalTrials.gov Identifier: | NCT00756730 History of Changes |
Health Authority: | United States: Food and Drug Administration |
lopinavir ritonavir atazanavir fosamprenavir darunavir anti-retroviral |
AIDS HIV LARD triglyceride protease inhibitors treatment Experienced |
Anti-Infective Agents 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 |
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 |