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| Sponsor: | California Collaborative Treatment Group |
|---|---|
| Collaborator: |
Abbott |
| Information provided by: | California Collaborative Treatment Group |
| ClinicalTrials.gov Identifier: | NCT00281606 |
Purpose
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 |
|---|---|---|
|
HIV Infection |
Drug: Different formulations of once-daily lopinavir/ritonavir |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| 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.
Eligibility| 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:
Contacts and Locations| United States, California | |
| UCI | Not yet recruiting |
| Irvine, California, United States, 92668 | |
| Principal Investigator: Jerimiah Tilles, MD | |
| USC | Not yet recruiting |
| Los Angeles, California, United States, 90033 | |
| Principal Investigator: Robert Larsen, MD | |
| UCSD | Not yet recruiting |
| San Diego, California, United States, 92103 | |
| Contact: Edward Seefried | |
| Principal Investigator: Richard Haubrich, MD | |
| Santa Clara Valley Medical Center | Not yet recruiting |
| San Jose, California, United States, 95128 | |
| Principal Investigator: Carol Kemper, CA | |
| Harbor-UCLA Medical Center | Not yet recruiting |
| Torrance, California, United States, 90502 | |
| Contact: Mario Guerrero, MD | |
| Principal Investigator: Eric Daar, MD | |
| Principal Investigator: | Eric Daar, MD | University of California, Los Angeles |
More Information
| ClinicalTrials.gov Identifier: | NCT00281606 History of Changes |
| Other Study ID Numbers: | CCTG 585 |
| Study First Received: | January 23, 2006 |
| Last Updated: | March 17, 2006 |
| Health Authority: | United States: Food and Drug Administration (IND Exempted) |
|
Lopinavir antiretroviral therapy cross-over tolerability |
|
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 Ritonavir |
Lopinavir HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses |