Long-term Study in Patients Under Anti-retroviral Combination Therapy Switching to Viramune®

• 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: Nevirapine; Reverse Transcriptase Inhibitors

Criteria

Inclusion Criteria:

• Adult male and female out-patients with HIV type 1 infection who have achieved a viral load below detection limit (50 copies/ml) for more than 6 months under a previous combination therapy with protease-inhibitors (PI) or non-nucleoside reverse transcriptase inhibitors (NNRTI)

• Women can only be included, if a test has excluded pregnancy

• Only women can be included, who use a reliable means of contraception during the observational study

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:

• Pregnancy

• Breast-feeding

• Insufficient or unreliable contraception