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

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	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

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
Overall Participants Analyzed  [Units: Participants]	334
Age  [Units: Years] Mean (Standard Deviation)	41.8  (9.8)
Gender  [Units: Participants]
Female	58
Male	276

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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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