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| Sponsor: | Abbott |
|---|---|
| Information provided by: | Abbott |
| ClinicalTrials.gov Identifier: | NCT00043953 |
Purpose
The objectives of this study are to explore the metabolic toxicities associated with lopinavir/ritonavir (LPV/r) plus saquinavir mesylate (INV) versus LPV/r plus Combivir in antiretroviral naïve subjects and to assess the overall safety, tolerability and efficacy of LPV/r plus INV versus LPV/r plus Combivir in antiretroviral naïve subjects and to assess the pharmacokinetics of 400 mg INV taken twice a day (BID), 600 mg INV BID and 800 mg INV BID in combination with 400 mg lopinavir/100 mg ritonavir plus 150 mg lamivudine/300 mg zidovudine BID.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Lopinavir/ritonavir Drug: Saquinavir mesylate Drug: Lamivudine/zidovudine |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Phase II Study of Lopinavir/Ritonavir in Combination With Saquinavir Mesylate or Lamivudine/Zidovudine to Explore Metabolic Toxicities in Antiretroviral HIV-Infected Subjects |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Screening laboratory analyses show any of the following abnormal laboratory results:
Contacts and Locations| United States, California | |
| Stephen Becker, MD | |
| San Francisco,, California, United States, 94115 | |
| Harbor UCLA, Research & Education Institute | |
| Torrance, California, United States, 90502 | |
| AHF Research | |
| Los Angeles, California, United States, 90015 | |
| Pacific Horizon Medical Group | |
| San Francisco, California, United States, 94115 | |
| AHF Research | |
| Los Angeles, California, United States, 90015 | |
| United States, Massachusetts | |
| Community Research Initiative of New England | |
| Boston,, Massachusetts, United States, 02215 | |
| Community Research Initiative of New England | |
| Springfield, Massachusetts, United States, 01107 | |
| United States, North Carolina | |
| University of North Carolina at Chapel Hill | |
| Chapel Hill,, North Carolina, United States, 27599 | |
| Duke University Medical Center | |
| Durham, North Carolina, United States, 27710 | |
| The University of North Carolina at Chapel Hill | |
| Chapel Hill, North Carolina, United States, 27599-7215 | |
| Duke University Medical Center | |
| Durham, North Carolina, United States, 27710 | |
| Canada | |
| University of Ottawa at the Ottawa Health Research Institute | |
| Ottawa,, Canada, K1H 8L6 | |
| University of Ottawa Health Research Institute | |
| Ottawa, Canada, K1H 8L6 | |
| Study Director: | Barbara A da Silva, M.D. | Associate Medical Director, Antiviral Global Project Team |
More Information
| Study ID Numbers: | M01-384 |
| Study First Received: | August 15, 2002 |
| Last Updated: | September 26, 2007 |
| ClinicalTrials.gov Identifier: | NCT00043953 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
treatment naive |
|
Antimetabolites Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Saquinavir Zidovudine Lamivudine Infection 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 Enzyme Inhibitors Antiviral Agents Immunologic Deficiency Syndromes Pharmacologic Actions Protease Inhibitors Virus Diseases HIV Infections Ritonavir Sexually Transmitted Diseases Lentivirus Infections |