Non-interventional Observational Study With Viramune (Nevirapine) and Various Drug Combinations in the Antiretroviral Combination Treatment of HIV-infected Patients Who Have Already Been Treated for Approx. 10 Years With Viramune

This study has been completed.

Sponsor:

Information provided by:

Boehringer Ingelheim

ClinicalTrials.gov Identifier:

NCT00979420

First received: September 16, 2009

Last updated: June 27, 2014

Last verified: June 2014

History of Changes

Results First Received: May 30, 2012

Study Type:	Observational
Study Design:	Time Perspective: Retrospective
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
Treatment-naive Patients	Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
Pre-treated Patients With Baseline HIV RNA <50 Copies/ml	HIV RNA denotes Human immunodeficiency virus (HIV) Ribonucleic acid (RNA). Baseline reflects the last available documentation before start of treatment with Viramune
Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml	Baseline reflects the last available documentation before start of treatment with Viramune
Pre-treated Patients With Baseline HIV RNA Not Documented	Baseline reflects the last available documentation before start of treatment with Viramune

Participant Flow: Overall Study

	Treatment-naive Patients	Pre-treated Patients With Baseline HIV RNA <50 Copies/ml	Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml	Pre-treated Patients With Baseline HIV RNA Not Documented
STARTED	178	57	60	61
COMPLETED	171	57	59	59
NOT COMPLETED	7	0	1	2
Adverse Event	1	0	0	0
Lack of Efficacy	3	0	1	1
Other reasons not related to Viramune	3	0	0	1

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.
Treated set - all patients receiving at least one dose of study medication

Reporting Groups

	Description
Treatment-naive Patients	Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
Pre-treated Patients With Baseline HIV RNA<50 Copies/ml	Baseline reflects the last available documentation before start of treatment with Viramune
Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml	Baseline reflects the last available documentation before start of treatment with Viramune
Pre-treated Patients With Baseline HIV RNA Not Documented	Baseline reflects the last available documentation before start of treatment with Viramune
Total	Total of all reporting groups

Baseline Measures

	Treatment-naive Patients	Pre-treated Patients With Baseline HIV RNA<50 Copies/ml	Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml	Pre-treated Patients With Baseline HIV RNA Not Documented	Total
Number of Participants [units: participants]	178	57	60	61	356
Age [units: Years] Mean ± Standard Deviation	50.85 ± 10.54	54.21 ± 10.42	51.02 ± 7.66	53.69 ± 11.05	51.91 ± 10.24
Gender, Customized [units: Participants]
Male	142	44	41	51	278
Female	36	13	19	9	77
Missing	0	0	0	1	1

Outcome Measures

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1. Primary:

Change in log10 Viral Load From Baseline to Last Visit [ Time Frame: Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months. ]

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2. Primary:

Number of Participants With Viral Load <50 Copies/ml and >=50 Copies/ml at Last Visit [ Time Frame: Last available visit. Duration of intake of Viramune ranges from 14 to 185 months. ]

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3. Primary:

Change in Absolute CD4 Lymphocytes (CD4+) Cells From Baseline to Last Visit [ Time Frame: Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months. ]

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4. Primary:

Change in log10 Viral Load From Baseline to Last Visit [ Time Frame: Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months. ]

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5. Primary:

Number of Participants With Viral Load <50 Copies/ml and >=50 Copies/ml at Last Visit [ Time Frame: Last available visit. Duration of intake of Viramune ranges from 14 to 185 months. ]

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6. Primary:

Change in Absolute CD4 Lymphocytes (CD4+ Cells) From Baseline to Last Visit [ Time Frame: Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months. ]

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7. Secondary:

Number of Patients With Laboratory Abnormalities for Cholesterol During Study (Worst Grade) by Division of AIDS (DAIDS) Grade [ Time Frame: Up to 185 months ]

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8. Secondary:

Number of Patients With Laboratory Abnormalities for Low-density Lipoprotein (LDL) Cholesterol During Study (Worst Grade) by DAIDS Grade [ Time Frame: Up to 185 months ]

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9. Secondary:

Number of Patients With Laboratory Abnormalities for Triglycerides During Study (Worst Grade) by DAIDS Grade [ Time Frame: Up to 185 months ]

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10. Secondary:

Number of Patients With Laboratory Abnormalities for Blood Glucose During Study (Worst Grade) by DAIDS Grade [ Time Frame: Up to 185 months ]

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11. Secondary:

Number of Patients With Laboratory Abnormalities for Alanine Aminotransferase (ALT) During Study (Worst Grade) by DAIDS Grade [ Time Frame: Up to 185 months ]

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12. Secondary:

Number of Patients With Laboratory Abnormalities for Aspartate Aminotransferase (AST) During Study (Worst Grade) by DAIDS Grade [ Time Frame: Up to 185 months ]

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13. Secondary:

Number of Patients With Laboratory Abnormalities for Creatinine During Study (Worst Grade) by DAIDS Grade [ Time Frame: Up to 185 months ]

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14. Secondary:

Number of Patients With Laboratory Abnormalities for Hemoglobin During Study (Worst Grade) by DAIDS Grade [ Time Frame: Up to 185 months ]

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15. Secondary:

Duration of Intake of Viramune [ Time Frame: End of treatment, up to 185 months ]

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16. Secondary:

History of Therapy With Antiretroviral Medication [ Time Frame: Baseline ]

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17. Secondary:

Course of Absolute CD4+ Cell Count [ Time Frame: Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months ]

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18. Secondary:

Number of Participants With Drug Related Adverse Events [ Time Frame: Up to 185 months ]

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Measure Type	Secondary
Measure Title	Number of Participants With Drug Related Adverse Events
Measure Description	Number of participants with drug related Adverse Events (AEs)
Time Frame	Up to 185 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.
Treated set

Reporting Groups

	Description
Treatment-naive Patients	Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
Pre-treated Patients With Baseline HIV RNA <50 Copies/ml	Baseline reflects the last available documentation before start of treatment with Viramune
Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml	Baseline reflects the last available documentation before start of treatment with Viramune
Pre-treated Patients With Baseline HIV RNA Not Documented	Baseline reflects the last available documentation before start of treatment with Viramune

Measured Values

	Treatment-naive Patients	Pre-treated Patients With Baseline HIV RNA <50 Copies/ml	Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml	Pre-treated Patients With Baseline HIV RNA Not Documented
Number of Participants Analyzed [units: participants]	178	57	60	61
Number of Participants With Drug Related Adverse Events [units: participants]	0	0	1	0

No statistical analysis provided for Number of Participants With Drug Related Adverse Events

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: 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.

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:	NCT00979420 History of Changes
Other Study ID Numbers:	1100.1535
Study First Received:	September 16, 2009
Results First Received:	May 30, 2012
Last Updated:	June 27, 2014
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

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