Observational Non-interventional Study With Viramune® in Combination With Truvada® in HIV-infected Patients

This study has been completed.

Sponsor:

Information provided by:

Boehringer Ingelheim Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT00543803

First received: October 8, 2007

Last updated: May 18, 2012

Last verified: May 2012

History of Changes

Results First Received: December 17, 2010

Study Type:	Observational
Study Design:	Observational Model: Cohort; Time Perspective: Prospective
Condition:	HIV Infections

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
Patients Treated With Viramune in Combination With Truvada	200mg bid for two weeks, then 200mg qd, Truvada one tablet qd

Participant Flow: Overall Study

	Patients Treated With Viramune in Combination With Truvada
STARTED	334
COMPLETED	192
NOT COMPLETED	142
Adverse Event	14
Lack of Efficacy	22
Lost to Follow-up	20
not specified	86

Baseline Characteristics

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Reporting Groups

	Description
Patients Treated With Viramune in Combination With Truvada	200mg bid for two weeks, then 200mg qd, Truvada one tablet qd

Baseline Measures

	Patients Treated With Viramune in Combination With Truvada
Number of Participants [units: participants]	334
Age [units: Years] Mean ± Standard Deviation	41.8 ± 9.8
Gender [units: Participants]
Female	58
Male	276

Outcome Measures

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1. Primary:

Summary of Change From Baseline in Alanine Aminotransferase (ALT) to Last Value on Treatment [ Time Frame: from baseline to last value on treatment in between 36 months ]

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2. Primary:

Summary of Change From Baseline in Asparate Aminotransferase (AST) to Last Value on Treatment [ Time Frame: from baseline to last value on treatment in between 36 months ]

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3. Primary:

Summary of Change From Baseline in Gamma-glutamyl Transferase (Gamma-GT) to Last Value on Treatment [ Time Frame: from baseline to last value on treatment in between 36 months ]

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4. Primary:

Summary of Change From Baseline in Creatinine to Last Value on Treatment [ Time Frame: from baseline to last value on treatment in between 36 months ]

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5. Primary:

Summary of Change From Baseline in Total Cholesterol to Last Value on Treatment [ Time Frame: from baseline to last value on treatment in between 36 months ]

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6. Primary:

Summary of Change From Baseline in High-density Lipoprotein (HDL) Cholesterol to Last Value on Treatment [ Time Frame: from baseline to last value on treatment in between 36 months ]

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7. Primary:

Summary of Change From Baseline in Low-density Lipoprotein (LDL) Cholesterol to Last Value on Treatment [ Time Frame: from baseline to last value on treatment in between 36 months ]

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8. Primary:

Summary of Change From Baseline in Triglycerides to Last Value on Treatment [ Time Frame: from baseline to last value on treatment in between 36 months ]

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9. Primary:

Summary of Change From Baseline in Glucose to Last Value on Treatment [ Time Frame: from baseline to last value on treatment in between 36 months ]

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10. Secondary:

Summary of Log10 Change From Baseline in Viral Load to Last Value on Treatment [ Time Frame: from baseline to last value on treatment in between 36 months ]

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11. Secondary:

Summary of Log10 Change From Baseline in CD4+ Count to Last Value on Treatment [ Time Frame: from baseline to last value on treatment in between 36 months ]

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Measure Type	Secondary
Measure Title	Summary of Log10 Change From Baseline in CD4+ Count to Last Value on Treatment
Measure Description	No text entered.
Time Frame	from baseline to last value on treatment in between 36 months
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.
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Reporting Groups

	Description
Patients Treated With Viramune in Combination With Truvada	200mg bid for two weeks, then 200mg qd, Truvada one tablet qd

Measured Values

	Patients Treated With Viramune in Combination With Truvada
Number of Participants Analyzed [units: participants]	334
Summary of Log10 Change From Baseline in CD4+ Count to Last Value on Treatment [units: (log10 cells) / mm^3] Median ( Inter-Quartile Range )	141 ( 30.5 to 276.5 )

No statistical analysis provided for Summary of Log10 Change From Baseline in CD4+ Count to Last Value on Treatment

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: Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.

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
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Results Point of Contact:

Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
phone: 1-800-243-0127
e-mail: clintriage.rdg@boehringer-ingelheim.com

No publications provided

Responsible Party:	Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier:	NCT00543803 History of Changes
Other Study ID Numbers:	1100.1492
Study First Received:	October 8, 2007
Results First Received:	December 17, 2010
Last Updated:	May 18, 2012
Health Authority:	Germany: BfArM-Bundesinstitut fuer Arzneimittel und Medizinprodukte (Federal Authoriteis for Drugs and Medica

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