Status:
COMPLETED
Long-term Study in Patients Under Anti-retroviral Combination Therapy Switching to Viramune®
Lead Sponsor:
Boehringer Ingelheim
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Brief 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 (Vira...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2002
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
228 Patients enrolled
Trial Details
Trial ID
NCT02191293
Start Date
May 1 2002
Last Update
July 16 2014
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