Observational Study With Antiretroviral Treated Patients Switching to Nevirapine Plus Two Nucleoside Reverse Transcriptase Inhibitor (NRTI) Regimens

Study Overview
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Brief Summary
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Collecting data on maintaining anti-retroviral activity (quantitative HIV RNA determination) and immunological activity (CD4 cells) after switching from protease inhibitor or NNRTI to Nevirapine (Viramune®) and collecting of routinely observed laboratory data on lipids, and liver enzymes.

Official Title
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Observational Study With Antiretroviral Treated Patients Switching Therapy Because of Therapeutic Reasons From Protease Inhibitor- or NNRTI-containing Regimens to Nevirapine Plus Two Nucleoside Reverse Transcriptase Inhibitor (NRTI) Regimens

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: Viramune®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients suffer from HIV type 1 infection Patient is treated with antiretroviral protease-inhibitors or non-nucleoside reverse transcriptase inhibitors Patient has shown a depression of viral load before limit of detection (< 50 HIV-RNA copies/ml) for more than 6 months prior to visit 1 Patient is male or female with age greater than or equal to 18 years Women have to be willing to use an effective barrier method of contraception for the duration of the observational study participation Exclusion Criteria: Patient has clinically relevant laboratory findings (e.g., aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > five times upper limit of normal (ULN)) Patients is hypersensitive to Viramune® or to any of its excipients Patient is not able to abstain from treatment with ketoconazole, oral contraceptives, or other drug affecting CYP3A-metabolism Patients is breast-feeding Patient is pregnant Patient is a woman and does not use effective contraception

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Viramune®<br>Patients switching from protease inhibitor (PI) or nonnucleoside reverse transcriptase inhibitor (NNRTI) containing antiretroviral regimen to Viramune® | Drug: Viramune®<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in viral load (HIV-RNA) |  | Baseline, up to 52 weeks | 
| Change in CD4 cell count |  | Baseline, up to 52 weeks | 
| Change in lipid parameters | mg/dl | Baseline, up to 52 weeks | 
| Change in glucose | mg/dl | Baseline, up to 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of subjective well-being | verbal rating scale | up to 52 weeks | 
| Assessment of tolerability by physician and patients | verbal rating scale | after 52 weeks | 
| Change in liver enzyme parameter | U/l | Baseline, up to 52 weeks | 
| Number of patients with adverse events |  | up to 52 weeks |