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Sponsors and Collaborators: |
California Collaborative Treatment Group Abbott |
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Information provided by: | California Collaborative Treatment Group |
ClinicalTrials.gov Identifier: | NCT00281606 |
Guidelines have continued to list lopinavir/ritonavir as a preferred protease inhibitor-containing regimen for HIV-infected individuals. There has recently been increasing interest in once daily therapy. While lopinavir/ritonavir has recently been approved as a once daily therapy it was associated with considerable diarrhea in those treated with soft gel capsules. It is the hope that alternative formulations of lopinavir/ritonavir may provide similar pharmacokinetics with improved tolerability. This includes the possibility of using liquid or newly released tablets. This study will treat people tolerating their current regimen with up to four weeks of each formulation with several assessments of pharmacokinetics and tolerability for each.
Condition | Intervention | Phase |
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HIV Infection |
Drug: Different formulations of once-daily lopinavir/ritonavir |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | A Phase IV, Randomized, Open-Label Study of the Tolerability of Once Daily Lopinavir/Ritonavir (LPV/r) Liquid Versus Capsules |
Estimated Enrollment: | 64 |
Estimated Study Completion Date: | August 2007 |
This study is designed to assess the tolerability of different forms (liquid, capsules or tablets) of lopinavir/ritonavir given once-daily as part of combination therapy for HIV infection. Study subjects will be those tolerating a stable regimen of HIV medications with undetectable levels of HIV in their blood. They will be assigned by chance to receive once daily liquid or soft gel capsules of lopinavir/ritonavir for up to four weeks. At that time they will receive the alternative formulation for up to four weeks. They will then be given once daily lopinavir/ritonavir in the recently released tablet formulation. After up to four weeks of each of these formulations several assessments will be made of the overall tolerability of the drug. After four weeks of tablets they will be allowed to take whatever regimen they want and will be followed for an additional 36 weeks for a total duration of study of up to 48 weeks. The pharmacokinetics of each formulation of lopinavir/ritonavir given once daily will also be assessed in a subset of study subjects.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Laboratory values:
-Hemoglobin >7.0 g/dL.
Exclusion Criteria:
United States, California | |
UCSD | |
San Diego, California, United States, 92103 | |
UCI | |
Irvine, California, United States, 92668 | |
Harbor-UCLA Medical Center | |
Torrance, California, United States, 90502 | |
USC | |
Los Angeles, California, United States, 90033 | |
Santa Clara Valley Medical Center | |
San Jose, California, United States, 95128 |
Principal Investigator: | Eric Daar, MD | University of California, Los Angeles |
Study ID Numbers: | CCTG 585 |
Study First Received: | January 23, 2006 |
Last Updated: | March 17, 2006 |
ClinicalTrials.gov Identifier: | NCT00281606 |
Health Authority: | United States: Food and Drug Administration (IND Exempted) |
Lopinavir antiretroviral therapy cross-over tolerability |
Virus Diseases Sexually Transmitted Diseases, Viral Lopinavir 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 |