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Sponsored by: |
Abbott |
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Information provided by: | Abbott |
ClinicalTrials.gov Identifier: | NCT00004578 |
To assess the safety, tolerability and antiviral activity of lopinavir/ritonavir when administered orally in antiretroviral-HIV-1 infected subjects.
Condition | Intervention | Phase |
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HIV Infections |
Drug: Lopinavir/Ritonavir Drug: Lamivudine Drug: Stavudine |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Official Title: | Phase I/II Study of ABT-378/Ritonavir in Combination With Reverse Transcriptase Inhibitors in Antiretroviral Naive HIV-Infected Patients |
Enrollment: | 100 |
Study Start Date: | November 1997 |
Study Completion Date: | April 2005 |
Primary Completion Date: | April 2005 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Group 1, n=32 initiated with ABT-378 & ritonavir; after 3 wks stavudine and lamivudine was added.
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Drug: Lopinavir/Ritonavir
Lopinavir, range from 200 mg to 400 mg, every 12 hrs and Ritonavir, range from 100 mg to 200 mg, every 12 hrs
Drug: Lamivudine
150 mg, every 12 hours
Drug: Stavudine
40 mg every 12 hours
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2: Active Comparator
Group II patients (n=68) to be randomized after all Group I patients are enrolled and safety analysis is completed.
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Drug: Lopinavir/Ritonavir
Lopinavir, range from 200 mg to 400 mg, every 12 hrs and Ritonavir, range from 100 mg to 200 mg, every 12 hrs
Drug: Lamivudine
150 mg, every 12 hours
Drug: Stavudine
40 mg every 12 hours
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Exclusion Criteria
History of:
United States, California | |
Pacific Oaks Research | |
Beverly Hills, California, United States, 90211 | |
United States, Colorado | |
University of Colorado Health Sciences Center | |
Denver, Colorado, United States, 80262 | |
United States, Georgia | |
AIDS Research Consortium of Atlanta | |
Atlanta, Georgia, United States, 30308 | |
United States, Illinois | |
Northwestern University Medical School | |
Chicago, Illinois, United States, 60611 | |
Rush-Presbyterian-St. Luke's Medical Center | |
Chicago, Illinois, United States, 60612 | |
United States, Massachusetts | |
Beth Israel Deaconess Medical Center | |
Boston, Massachusetts, United States, 02215 | |
United States, New York | |
Cornell Clinical Trials Unit - Chelsea Center | |
New York, New York, United States, 10011 | |
United States, North Carolina | |
Duke University Medical Center | |
Durham, North Carolina, United States, 27710 | |
University of North Carolina at Chapel Hill | |
Chapel Hill, North Carolina, United States, 27516 | |
United States, Texas | |
Baylor College of Medicine | |
Houston, Texas, United States, 77030 |
Study Director: | George Hanna, MD | Abbott |
Responsible Party: | Abbott ( George Hanna, MD, Anti-viral Global Project Head ) |
Study ID Numbers: | 285A, M97-720 |
Study First Received: | November 2, 1999 |
Last Updated: | April 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00004578 |
Health Authority: | United States: Food and Drug Administration |
Stavudine HIV Protease Inhibitors Ritonavir Lamivudine Reverse Transcriptase Inhibitors |
Virus Diseases Sexually Transmitted Diseases, Viral Stavudine Lopinavir Ritonavir HIV Infections |
Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Lamivudine Retroviridae Infections Immunologic Deficiency Syndromes |
Antimetabolites Anti-Infective Agents HIV Protease Inhibitors RNA Virus Infections Anti-HIV Agents Slow Virus Diseases Immune System Diseases Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors |
Infection Antiviral Agents Pharmacologic Actions Protease Inhibitors Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Lentivirus Infections Nucleic Acid Synthesis Inhibitors |