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

Completed

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

• Registration Number: NCT02191319
• 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: 2002-01
• Primary Completion: 2004-08
• 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: 55

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Change in CD4 cell count	Baseline, up to 52 weeks
Change in viral load (HIV-RNA)	Baseline, up to 52 weeks
Change in lipid parameters	Baseline, up to 52 weeks	mg/dl
Change in glucose	Baseline, up to 52 weeks	mg/dl

Secondary Outcome Measures

Name	Time	Method
Change in liver enzyme parameter	Baseline, up to 52 weeks	U/l
Assessment of subjective well-being	up to 52 weeks	verbal rating scale
Assessment of tolerability by physician and patients	after 52 weeks	verbal rating scale
Number of patients with adverse events	up to 52 weeks