Evaluation of Kaletra Therapy Over the Long-term

This study has been completed.

Sponsor:

Information provided by:

Abbott

ClinicalTrials.gov Identifier:

NCT01083810

First received: February 26, 2010

Last updated: August 9, 2011

Last verified: August 2011

History of Changes

Results First Received: June 30, 2011

Study Type:	Observational
Study Design:	Observational Model: Case-Only; Time Perspective: Prospective
Condition:	Human Immunodeficiency Virus
Intervention:	Drug: Lopinavir/Ritonavir (Kaletra)

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
These three groups of participants with HIV-1 infection were at first registered as three different studies: KAL1RO (this study, NCT01083810, n=137), KAL2RO /KAL5RO (NCT01083836, n=92), and KAL6RO (NCT01081470, n=55) but were now reconciled under KAL1RO (NCT01083810) as a single study with three reporting groups.

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
Therapy-naive	Participants who had not received prior antiretroviral drug therapy.
Pre-treated	Participants that had previously received antiretroviral therapy, but were protease inhibitor naive.
Non-B	Participants infected with non-B subtypes of HIV-1.

Participant Flow: Overall Study

	Therapy-naive	Pre-treated	Non-B
STARTED	137	92	55
COMPLETED	72	47	35
NOT COMPLETED	65	45	20
Lost to Follow-up	23	11	4
Adverse Event	15	11	4
Withdrawal by Subject	7	2	4
Reason not reported	6	1	1
Non-compliance	4	7	2
Simplification	4	1	0
Death	2	2	3
Co-morbidities	1	0	0
Participation in study	1	0	0
Therapy break	1	2	2
Virologic failure	1	8	0

Baseline Characteristics

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Reporting Groups

	Description
Therapy-naive	Participants who had not received prior antiretroviral drug therapy.
Pre-treated	Participants that had previously received antiretroviral therapy, but were protease inhibitor naive.
Non-B	Participants infected with non-B subtypes of HIV-1.
Total	Total of all reporting groups

Baseline Measures

	Therapy-naive	Pre-treated	Non-B	Total
Number of Participants [units: participants]	137	92	55	284
Age, Customized [units: Participants]
>= 18 years of age (exact age not reported)	137	92	55	284
Gender, Customized [units: Participants]
Female	17	11	20	48
Male	119	81	35	235
Gender not reported	1	0	0	1
Region of Enrollment [units: participants]
Germany	137	92	55	284

Outcome Measures

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1. Primary:

Number of Patients With Virus That Develop Mutations Conferring Resistance to Lopinavir/Ritonavir, NRTIs or NNRTIs [ Time Frame: Baseline and at any timepoint where testing is possible ]

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2. Secondary:

Percentage of Patients With HIV-1 RNA <50 Copies/ml [ Time Frame: Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks ]

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3. Secondary:

Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml [ Time Frame: Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks ]

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Measure Type	Secondary
Measure Title	Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml
Measure Description	All 3 protocols recommended that HIV viral load tests be performed at Baseline and each study visit. Study visits were to occur at approximately Weeks 4, 12, and 24, followed by 12-week intervals up to Week 144 in therapy-naive participants and up to Week 240 in the pre-treated and non-B subtype groups. The percentage of participants with HIV-1 RNA levels of 50 to less than 200 copies/mL at each time point is presented by subgroup.
Time Frame	Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks
Safety Issue	No

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.
All participants with HIV-1 RNA measurements at Baseline and any subsequent time point are presented, including those who discontinued due to virologic failure.

Reporting Groups

	Description
Therapy-naive	Participants who had not received prior antiretroviral drug therapy.
Pre-treated	Participants that had previously received antiretroviral therapy, but were protease inhibitor naive.
Non-B	Participants infected with non-B subtypes of HIV-1.

Measured Values

	Therapy-naive	Pre-treated	Non-B
Number of Participants Analyzed [units: participants]	137	92	55
Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml [units: Percentage of participants]
Baseline	1	5	0
Week 4	17	15	14
Week 12	32	15	25
Week 24	22	20	18
Week 36	18	9	10
Week 48	10	12	5
Week 60	13	10	6
Week 72	5	17	3
Week 84	9	13	6
Week 96	6	9	10
Week 108	14	8	4
Week 120	5	3	4
Week 132	3	13	0
Week 144	0	0	0
Week 156	NA ^[1]	0	0
Week 168	NA ^[1]	0	0
Week 180	NA ^[1]	5	8
Week 192	NA ^[1]	5	0
Week 204	NA ^[1]	6	0
Week 216	NA ^[1]	10	0
Week 228	NA ^[1]	0	25
Week 240	NA ^[1]	0	0

[1]	Values not available (NA) as data were collected out to Week 144 in the subgroup of therapy-naive participants.

No statistical analysis provided for Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml

4. Secondary:

Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml [ Time Frame: Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks ]

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5. Secondary:

Percentage of Patients With HIV-1 RNA >500 Copies/ml [ Time Frame: Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks ]

Show Outcome Measure 5

6. Secondary:

Change in Absolute CD4 Cell Count [CD4+ Cells/µL] [ Time Frame: Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks ]

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Serious Adverse Events

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Other Adverse Events

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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: Abbott requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. Abbott requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if Abbott needs to secure patent or proprietary protection.

Limitations and Caveats

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
No text entered.

Results Point of Contact:

Name/Title: Global Medical Services
Organization: Abbott
phone: 1-800-633-9110

No publications provided

Responsible Party:	Dr. Stefan Simianer, Medical Director, Medical Department, Abbott Germany (Wiesbaden)
ClinicalTrials.gov Identifier:	NCT01083810 History of Changes
Obsolete Identifiers:	NCT01081470, NCT01083836
Other Study ID Numbers:	KAL 1 RO
Study First Received:	February 26, 2010
Results First Received:	June 30, 2011
Last Updated:	August 9, 2011
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

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