A Study of Lopinavir/Ritonavir Tablets Comparing Once-Daily Versus Twice-Daily Dosing in Antiretroviral-Experienced, HIV-1 Infected Subjects - Full Text View

Sponsored by:	Abbott
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00358917

Purpose

The purpose of this study is to determine whether once-daily dosing of the lopinavir/ritonavir tablet in combination with investigator-selected nucleoside/nucleotide reverse transcriptase inhibitors will reduce viral load to very low levels in patients who have detectable viral loads with their current antiretroviral therapy.

Condition	Intervention	Phase
HIV Infection	Drug: lopinavir/ritonavir	Phase III

MedlinePlus related topics: AIDS

Drug Information available for: Ritonavir Lopinavir

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment
Official Title:	A Phase 3, Randomized, Open-Label Study of Lopinavir/Ritonavir Tablets 800/200 mg Once-Daily Versus 400/100 mg Twice-Daily When Coadministered With Nucleoside/Nucleotide Reverse Transcriptase Inhibitors in Antiretroviral-Experienced, HIV-1 Infected Subjects

Further study details as provided by Abbott:

Primary Outcome Measures:

The proportion of subjects responding (i.e., not demonstrating virologic failure) based on the FDA Time to Loss of Virologic Response Algorithm [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
The frequency and percentage of treatment-emergent adverse events [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
The frequency and percentage of very low and very high laboratory values will be compared between treatment groups [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
The change from baseline to each visit for laboratory values will be summarized by treatment group [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

The relationship between baseline genotypic resistance and virologic response [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
The frequency and percentage of the emergence of mutations at virologic rebound that were not present at baseline [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Enrollment:	600
Study Start Date:	September 2006
Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
BID: Active Comparator	Drug: lopinavir/ritonavir tablet (400/100 mg BID)
QD: Experimental	Drug: lopinavir/ritonavir tablet (800/200 mg QD)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subject has provided written informed consent
Subject is currently receiving an antiretroviral regimen which has not changed for at least 12 weeks
Subject has never received lopinavir/ritonavir
Subject is currently failing his/her antiretroviral regimen with the most recent two consecutive pre-study plasma HIV-1 RNA levels > 400 copies/mL with the most recent being > 1000 copies/mL, and in the investigator's opinion, should change therapy
Screening plasma HIV-1 RNA > 1000 copies/mL
No CD4+ T-cell count restriction
No significant history of cardiac, renal, neurological, psychiatric, oncologic, metabolic or hepatic disease that would adversely affect his/her participating in the study
Based on HIV-1 drug resistance genotypic test results at the Screening Visit and prior treatment history, the investigator considers lopinavir/ritonavir plus at least two NRTIs to be an appropriate treatment for the subject
Subject does not require and agrees not to take any antiretroviral medication except lopinavir/ritonavir and NRTIs

Exclusion Criteria:

-

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00358917

Locations

United States, Illinois
Global Medical Information - Abbott (1-800-633-9110)
Abbott Park, Illinois, United States, 60064

Sponsors and Collaborators

Abbott

Investigators

Study Director:

Thomas J Podsadecki, MD

Abbott

More Information

Responsible Party:	Abbott ( Thomas J. Podsadecki, MD/Study Director )
Study ID Numbers:	M06-802
Study First Received:	July 28, 2006
Last Updated:	December 3, 2008
ClinicalTrials.gov Identifier:	NCT00358917
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
Lopinavir
Ritonavir
HIV Infections

Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on January 16, 2009