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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: HIV Protease Inhibitors; Nevirapine; Protease Inhibitors; Reverse Transcriptase Inhibitors

Criteria

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