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

Boehringer Ingelheim

Status: Completed

Conditions: HIV Infections

Treatments: Drug: Viramune® tablets

Study type: Observational

Funder types: Industry

Identifiers

NCT02191293

1100.1402

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: 228 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

228 participants in 1 patient group

Viramune®

Treatment:

Drug: Viramune® tablets