Status:
COMPLETED
Observational Study With Antiretroviral Treated Patients Switching to Nevirapine Plus Two Nucleoside Reverse Transcriptase Inhibitor (NRTI) Regimens
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
- 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
- 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
Key Trial Info
Start Date :
January 1 2002
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT02191319
Start Date
January 1 2002
Last Update
July 16 2014
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