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

Boehringer Ingelheim

Status: Completed

Conditions: HIV Infections

Treatments: Drug: Viramune®

Study type: Observational

Funder types: Industry

Identifiers

NCT02191319

1100.1395

Details and patient eligibility

About

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.

Enrollment: 55 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

55 participants in 1 patient group

Viramune®

Description:

Patients switching from protease inhibitor (PI) or nonnucleoside reverse transcriptase inhibitor (NNRTI) containing antiretroviral regimen to Viramune®

Treatment:

Drug: Viramune®