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Sponsors and Collaborators: |
The HIV Netherlands Australia Thailand Research Collaboration Hoffmann-La Roche International Antiviral Therapy Evaluation Center The National Centre in HIV Epidemiology and Clinical Research |
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Information provided by: | The HIV Netherlands Australia Thailand Research Collaboration |
ClinicalTrials.gov Identifier: | NCT00400738 |
Treatment with only protease inhibitors might benefit HIV patients. Laboratory data have shown that the combination of saquinavir with lopinavir and ritonavir may a good regimen. This study will explore this idea.
Condition | Intervention | Phase |
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HIV Infections |
Drug: Saquinavir, lopinavir, ritonavir |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Pharmacokinetics/Dynamics Study |
Official Title: | Pharmacokinetics of and Rate of HIV-1 RNA Decline in ARV-Naive HIV-1 Infected Patients Treated With Low- or Standard-Dose Saquinavir HGC (Invirase®) and Lopinavir/Ritonavir (Kaletra® |
Enrollment: | 48 |
Study Start Date: | March 2004 |
Study Completion Date: | December 2006 |
Primary Completion Date: | December 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
different dose per arm
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Drug: Saquinavir, lopinavir, ritonavir
arm 1 = LPV/RTV 400/100 mg BID + SQV 1000 mg BID arm 2 = LPV/RTV 400/100 mg BID + SQV 600 mg BID arm 3 = LPV/RTV 266/66 mg BID + SQV 1000 mg BID arm 4 = LPV/RTV 266/66 mg BID + SQV 600 mg BID
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2: Experimental
different dose per arm
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Drug: Saquinavir, lopinavir, ritonavir
arm 1 = LPV/RTV 400/100 mg BID + SQV 1000 mg BID arm 2 = LPV/RTV 400/100 mg BID + SQV 600 mg BID arm 3 = LPV/RTV 266/66 mg BID + SQV 1000 mg BID arm 4 = LPV/RTV 266/66 mg BID + SQV 600 mg BID
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3: Experimental
different dose per arm
|
Drug: Saquinavir, lopinavir, ritonavir
arm 1 = LPV/RTV 400/100 mg BID + SQV 1000 mg BID arm 2 = LPV/RTV 400/100 mg BID + SQV 600 mg BID arm 3 = LPV/RTV 266/66 mg BID + SQV 1000 mg BID arm 4 = LPV/RTV 266/66 mg BID + SQV 600 mg BID
|
4: Experimental
different dose per arm
|
Drug: Saquinavir, lopinavir, ritonavir
arm 1 = LPV/RTV 400/100 mg BID + SQV 1000 mg BID arm 2 = LPV/RTV 400/100 mg BID + SQV 600 mg BID arm 3 = LPV/RTV 266/66 mg BID + SQV 1000 mg BID arm 4 = LPV/RTV 266/66 mg BID + SQV 600 mg BID
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Treatment with only protease inhibitors might benefit HIV patients, who experience problems with the other antiretrovirals drugs classes. Another reason to only use protease inhibitors is that the remaining classes are spared. This leaves the option to use these classes in the future, for instance in cases of drug resistance. Laboratory data have shown that the combination of saquinavir with lopinavir and ritonavir may a good regimen. This study will explore this idea.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Thailand | |
The HIV Netherlands Australia Thailand Research Collaboration | |
Bangkok, Thailand, 10330 |
Principal Investigator: | Kiat Ruxrunghtam, MD, PhD | The HIV Netherlands Australia Thailand Research Collaboration |
Study Chair: | Joep Lange, MD, PhD | International Antiviral Therapy Evaluation Center (IATEC), Center for Poverty-related Communicable Diseases, Department of Internal Medicine, Academic Medical Center (AMC), University of Amsterdam (UVA) |
Study Chair: | Praphan Phanuphak, MD, PhD | The HIV Netherlands Australia Thailand Research Collaboration |
Study Chair: | David Burger, PharmD, PhD | Radboud University |
Study Chair: | David Cooper, MD, PhD | National Center in HIV Epidemiology and Clinical Research |
Responsible Party: | HIV-NAT ( Kiat Ruxrungtham ) |
Study ID Numbers: | HIV-NAT 019 |
Study First Received: | November 9, 2006 |
Last Updated: | June 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00400738 |
Health Authority: | Thailand: Food and Drug Administration |
HIV-1 infection pharmacokinetics protease inhibitor |
double boosted protease inhibitors PIs Treatment Naive |
Virus Diseases Sexually Transmitted Diseases, Viral Lopinavir Saquinavir Ritonavir |
HIV Infections Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes |
Anti-Infective Agents RNA Virus Infections HIV Protease Inhibitors Slow Virus Diseases Anti-HIV Agents Immune System Diseases Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors |
Infection Antiviral Agents Pharmacologic Actions Protease Inhibitors Anti-Retroviral Agents Therapeutic Uses Lentivirus Infections |