Clinical, Virological and Safety Outcomes of a Lopinavir/Ritonavir-Based Regimen in HIV-1 Infected Patients in Routine Clinical Use in China

This study has been completed.

Sponsor:

Information provided by:

Abbott

ClinicalTrials.gov Identifier:

NCT01074931

First received: February 22, 2010

Last updated: July 7, 2011

Last verified: July 2011

History of Changes

Results First Received: May 20, 2011

Study Type:	Observational
Study Design:	Time Perspective: Prospective
Condition:	HIV-1 Infections
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
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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
Lopinavir/Ritonavir Group	Adult participants with HIV-1 infection taking lopinavir/ritonavir

Participant Flow: Overall Study

	Lopinavir/Ritonavir Group
STARTED	98
COMPLETED	92
NOT COMPLETED	6
Economic reasons	1
Death	5

Baseline Characteristics

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Reporting Groups

	Description
Lopinavir/Ritonavir Group	Adult participants with HIV-1 infection taking lopinavir/ritonavir

Baseline Measures

	Lopinavir/Ritonavir Group
Number of Participants [units: participants]	98
Age [units: years] Mean ± Standard Deviation	39.86 ± 10.41
Gender [units: participants]
Female	27
Male	71
Region of Enrollment [units: participants]
China	98
Age at HIV-1 Diagnosis ^[1] [units: years] Mean ± Standard Deviation	36.35 ± 10.89
Participant Classification ^[2] [units: Participants]
Treatment-experienced	90
Treatment-naive	8
WHO Clinical Staging ^[3] [units: Participants]
Stage 1 (asymptomatic)	8
Stage 2 (mild symptoms)	22
Stage 3 (advanced symptoms)	32
Stage 4 (severe symptoms)	36
Body Weight ^[4] [units: kilograms] Mean ± Standard Deviation	56.91 ± 11.14
Lipodystrophy ^[5] [units: Participants]
Lipodystrophy not present	56
Mild lipodystrophy present	30
Moderate lipodystrophy present	11
Severe lipodystrophy present	1
Antiretroviral Treatment within Previous 6 Months ^[6] [units: Particpants]
Yes	89
No	8
Not reported	1
Other Chronic Diseases Present ^[7] [units: participants]
No	67
Yes	29
Not reported	2

[1]	The mean age at which participants were diagnosed with HIV-1, based on 97 participants.
[2]	Participants were classified as either treatment-naive or treatment experienced.
[3]	Participants were staged according to the World Health Organization (WHO) clinical classification of established HIV infection: Stage 1 (asymptomatic), Stage 2 (mild symptoms), Stage 3 (advanced symptoms), and Stage 4 (severe symptoms).
[4]	Participant body weight at study entry.
[5]	The presence and severity of lipodystrophy (abnormal body fat distribution) at study entry.
[6]	Whether or not the participant had antiretroviral treatment within 6 months prior to study entry.
[7]	Whether or not the participant had a chronic disease that had developed previously or was identified at study entry.

Outcome Measures

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1. Primary:

Evolution of the HIV Viral Response [ Time Frame: Month 3, 6, 12, 18 ]

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Measure Type	Primary
Measure Title	Evolution of the HIV Viral Response
Measure Description	The protocol recommended that HIV viral load tests be performed at baseline and each study visit. Test results indicate the number of HIV-1 ribonucleic acid (RNA) copies per milliliter (mL). The number of participants who underwent testing and had detectable levels (greater than 50 copies/mL) or undetectable levels (less than 50 copies/mL) are presented by subgroup. Study visits were to occur at approximately 3, 6, 12, and 18 months after starting treatment. The exact dates of each visit depended on the physician’s judgment, so data are reported for Visits 1 through 4 rather than by month.
Time Frame	Month 3, 6, 12, 18
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 who took at least one dose of lopinavir/ritonavir and had HIV viral load testing.

Reporting Groups

	Description
Lopinavir/Ritonavir: Treatment-naive	The subgroup of participants who had not received prior antiretroviral drug therapy.
Lopinavir/Ritonavir: Treatment-experienced	The subgroup of participants who had previously received antiretroviral drug therapy.

Measured Values

	Lopinavir/Ritonavir: Treatment-naive	Lopinavir/Ritonavir: Treatment-experienced
Number of Participants Analyzed [units: participants]	1	66
Evolution of the HIV Viral Response [units: participant]
Viral load detectable at Baseline	0	51
Viral load detectable at Visit 1	0	3
Viral load detectable at Visit 2	0	12
Viral load detectable at Visit 3	0	5
Viral load detectable at Visit 4	0	5
Viral load undetectable at Baseline	1	15
Viral load undetectable at Visit 1	0	22
Viral load undetectable at Visit 2	0	39
Viral load undetectable at Visit 3	1	47
Viral load undetectable at Visit 4	0	25

No statistical analysis provided for Evolution of the HIV Viral Response

2. Primary:

Evolution of CD4 Count [ Time Frame: Month 3, 6, 12, 18 ]

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3. Primary:

Evolution of the Tolerance Issues [ Time Frame: Month 3, 6, 12, 18 ]

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4. Secondary:

Number of Participants Who Missed Doses, Interrupt or Discontinue Regimen, and Experience Changes in Dosage or of Combination Regimen [ Time Frame: Month 3, 6, 12, 18 ]

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5. Secondary:

Adverse Events Observed and Development of Lipodystrophy Lesion and Their Locations [ Time Frame: Month 3, 6, 12, 18 ]

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6. Secondary:

The Duration on Treatment Until Development of an Adverse Event Leading to Treatment Discontinuation or Until Escape From Treatment [ Time Frame: Month 3, 6, 12, 18 ]

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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
The location of lipodystrophy was not summarized as there was not a place to record the information on the case report form. Too few participants withdrew from treatment to conduct planned analyses of duration to adverse event(s)/discontinuation.

Results Point of Contact:

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

No publications provided

Responsible Party:	Yue Kang, Abbott China
ClinicalTrials.gov Identifier:	NCT01074931 History of Changes
Other Study ID Numbers:	P10-398
Study First Received:	February 22, 2010
Results First Received:	May 20, 2011
Last Updated:	July 7, 2011
Health Authority:	China: Food and Drug Administration

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