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

ClinicalTrials.gov Identifier:

NCT00543803

First received: October 8, 2007

Last updated: May 13, 2014

Last verified: May 2014

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

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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	Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, 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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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.
FAS - All patients were considered for the full analysis set.

Reporting Groups

	Description
Patients Treated With Viramune in Combination With Truvada	Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, 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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Measure Type	Primary
Measure Title	Summary of Change From Baseline in Low-density Lipoprotein (LDL) Cholesterol to Last Value on Treatment
Measure Description	The change in Low-density lipoprotein (LDL) cholesterol from baseline to the last value in treatment
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.
FAS- All patients were considered for the full analysis set.

Reporting Groups

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

Measured Values

	Patients Treated With Viramune in Combination With Truvada
Number of Participants Analyzed [units: participants]	208
Summary of Change From Baseline in Low-density Lipoprotein (LDL) Cholesterol to Last Value on Treatment [units: mg/dl] Median ( Inter-Quartile Range )	5.0 ( -15.0 to 27.5 )

No statistical analysis provided for Summary of Change From Baseline in Low-density Lipoprotein (LDL) Cholesterol to Last Value on Treatment

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 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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12. Secondary:

Number of Patients With Non-serious Drug-related AEs as Judged by the Investigator [ Time Frame: from baseline to last value on treatment in between 36 months ]

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13. Secondary:

Investigator's Global Clinical Assessment of Patient General Health Status [ Time Frame: from baseline to last value on treatment in between 36 months ]

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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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