Study of Lopinavir/Ritonavir Tablets Comparing Once-Daily Versus Twice-Daily Administration When Coadministered With Nucleoside/Nucleotide Reverse Transcriptase Inhibitors in Antiretroviral-Experienced Human Immunodeficiency Virus Type 1 Infected Subjects

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition:	Human Immunodeficiency Virus Infections
Intervention:	Drug: lopinavir/ritonavir (LPV/r) tablet with nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs)

  Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
LPV/r 800/200 mg QD Tablet	lopinavir/ritonavir 800/200 milligram (mg) once daily (QD) tablet
LPV/r 400/100 mg BID Tablet	lopinavir/ritonavir 400/100 milligram (mg) twice daily (BID) tablet

Participant Flow:   Overall Study

	LPV/r 800/200 mg QD Tablet	LPV/r 400/100 mg BID Tablet
STARTED	300	299
COMPLETED	234	230
NOT COMPLETED	66	69
Adverse Event	14	21
Withdrawal by Subject	5	7
Lost to Follow-up	20	17
Noncompliance	12	11
Death	2	3
Virologic failure	11	8
Unable to Continue Participation	2	2

  Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

	Description
LPV/r 800/200 mg QD Tablet	lopinavir/ritonavir 800/200 mg once daily (QD) tablet
LPV/r 400/100 mg BID Tablet	lopinavir/ritonavir 400/100 mg twice daily (BID) tablet
Total	Total of all reporting groups

Baseline Measures

	LPV/r 800/200 mg QD Tablet	LPV/r 400/100 mg BID Tablet	Total
Overall Participants Analyzed; [Units: Participants]	300	299	599
Age; [Units: Years]; Mean (Standard Deviation)	40.4 (9.22)	40.8 (8.63)	40.6 (8.92)
Gender; [Units: Participants]
Female	103	103	206
Male	197	196	393
Received Prior Nonnucleoside Reverse Transcriptase Inhibitor (NNRTI); [Units: Participants]
Received Prior NNRTI	264	241	505
Did Not Receive Prior NNRTI	36	58	94
Received Prior Nucleoside/nucleotide Reverse Transcriptase Inhibitor (NRTI); [Units: Participants]
Received Prior NRTI	299	297	596
Did Not Receive Prior NRTI	1	2	3
Received Prior Protease Inhibitor (PI); [Units: Participants]
Received Prior PI	140	136	276
Did Not Receive Prior PI	160	163	323
Cluster of Differentiation 4 Single-Positive Thymocyte (CD4+ T) Cell Count; [Units: Cells/microliter]; Mean (Standard Deviation)	239.3 (158.39)	268.3 (183.55)	253.9 (171.98)
Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Level; [Units: Log10 copies/milliliter (mL)]; Mean (Standard Deviation)	4.26 (0.826)	4.26 (0.809)	4.26 (0.817)

  Outcome Measures

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1. Primary:

Percentage of Participants Responding at Week 48 Based on the Food and Drug Administration (FDA) Time to Loss of Virologic Response (TLOVR) Algorithm [ Time Frame: Week 48 (End of Study) ]

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2. Secondary:

Percentage of Participants With Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 50 Copies/Milliliter (mL) at Week 48 [ Time Frame: Week 48 (End of Study) ]

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3. Secondary:

Mean Change From Baseline to Week 48 in Cluster of Differentiation 4 Single-Positive Thymocyte (CD4+ T) Cell Counts [ Time Frame: Week 48 (End of Study) ]

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4. Secondary:

Virologic Response (HIV-1 RNA <50 Copies/mL) at Week 48 for Participants With 0-2 Protease Inhibitor Substitutions at Baseline Associated With Reduced Response to Lopinavir/Ritonavir [ Time Frame: Week 48 (End of Study) ]

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5. Secondary:

Percentage of Participants With New Primary Protease Mutations at Week 48 [ Time Frame: Week 48 (End of Study) ]

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  Serious Adverse Events

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  Other Adverse Events

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  Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

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Certain Agreements:  

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is: The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo. The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo. Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.; Restriction Description: This study has varying agreements that have been negotiated individually; however, it appears that the most restrictive of the agreements states that following the first publication/presentation of the study by Abbott (or twelve [12] months after the completion of the study at all sites, whichever occurs first), the Principal Investigator (PI) shall, during a period of twelve (12) months, have the right to publish/present the results of the site.

Results Point of Contact:  

Name/Title: Medical Information Specialist
Organization: Abbott
phone: 800-633-9110

Responsible Party:	Barry Bernstein, MD, Project Director, Abbott
ClinicalTrials.gov Identifier:	NCT00358917 History of Changes
Other Study ID Numbers:	M06-802
First Submitted:	July 28, 2006
First Posted:	August 1, 2006
Results First Submitted:	November 12, 2009
Results First Posted:	February 1, 2010
Last Update Posted:	April 11, 2011