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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: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 | |
| AHF Research | |
| Los Angeles, California, United States, 90015 | |
| Pacific Horizon Medical Group | |
| San Francisco, California, United States, 94115 | |
| Stephen Becker, MD | |
| San Francisco,, California, United States, 94115 | |
| Harbor UCLA, Research & Education Institute | |
| Torrance, California, United States, 90502 | |
| 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 | |
| The University of North Carolina at Chapel Hill | |
| Chapel Hill, North Carolina, United States, 27599-7215 | |
| University of North Carolina at Chapel Hill | |
| Chapel Hill,, North Carolina, United States, 27599 | |
| Duke University Medical Center | |
| Durham, North Carolina, United States, 27710 | |
| Canada | |
| University of Ottawa Health Research Institute | |
| Ottawa, Canada, K1H 8L6 | |
| University of Ottawa at the 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
| ClinicalTrials.gov Identifier: | NCT00043953 History of Changes |
| Other Study ID Numbers: | M01-384 |
| Study First Received: | August 15, 2002 |
| Last Updated: | September 26, 2007 |
| Health Authority: | United States: Food and Drug Administration |
|
treatment naive |
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Zidovudine Lamivudine Lamivudine, zidovudine drug combination Saquinavir |
Ritonavir Lopinavir Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Anti-HIV Agents HIV Protease Inhibitors Protease Inhibitors |