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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Viramune® |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Viramune® tablets | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in viral load (HIV-RNA) | Baseline, up to 36 months | |
| Changes in CD4 cell count | Baseline, up to 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in body weight | Baseline, up to 36 months | |
| Changes in general well-being assessed on a 4-point scale | Baseline, up to 36 months | |
| Changes in lipid parameters |
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Inclusion Criteria:
Exclusion Criteria:
Known sensitivity to Viramune or one of its excipients
Clinically relevant changes in lab findings (e.g. increase in aspartate aminotransferase (AST) or alanine aminotransferase (ALT) by more than five-fold of upper limit normal)
Patient is not able to abstain from treatment with ketoconazole, oral contraceptives, and other medication CYP3A metabolism
For females:
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HIV treatment centres and HIV out-patient facilities
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| ID | Term |
|---|---|
| D019829 | Nevirapine |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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mg/dl |
| Baseline, up to 36 months |
| Changes in glucose | mg/dl | Baseline, up to 36 months |
| Changes in liver enzymes | U/l | Baseline, up to 36 months |
| Number of patients with adverse events | up to 36 months |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |