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

Completed

• Conditions: HIV Infections
• Interventions: Drug: Viramune® tablets

• Registration Number: NCT02191293
• Lead Sponsor: Boehringer Ingelheim

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 (Viramune®) and collecting of routinely observed laboratory data on lipids, and liver enzymes.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-05
• Primary Completion: 2006-09
• Status Verified: 2014-07
• Study First Submitted: 2014-07-15
• Study First Submitted QC: 2014-07-15
• Last Update Submitted: 2014-07-15
• Study First Posted: 2014-07-16
• Last Update Posted: 2014-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 228

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Viramune®	Viramune® tablets	-

Primary Outcome Measures

Name	Time	Method
Changes in viral load (HIV-RNA)	Baseline, up to 36 months
Changes in CD4 cell count	Baseline, up to 36 months

Secondary Outcome Measures

Name	Time	Method
Changes in body weight	Baseline, up to 36 months
Changes in general well-being assessed on a 4-point scale	Baseline, up to 36 months
Changes in lipid parameters	Baseline, up to 36 months	mg/dl
Changes in glucose	Baseline, up to 36 months	mg/dl
Changes in liver enzymes	Baseline, up to 36 months	U/l
Number of patients with adverse events	up to 36 months