Observational Study in Patients With HIV Infection Type 1 After Switching to a Viramune®-Containing Therapy Regimen

Completed

• Conditions: HIV Infections
• Interventions: Drug: Viramune

• Registration Number: NCT02191332
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

Observational study to collect data on maintaining anti-retroviral activity (quantitative HIV RNA determination) and immunological activity (CD4 cells) despite switching from protease inhibitor to nonnucleoside reverse transcriptase inhibitor (NNRTI) (Viramune®).

Detailed Description

Not available

Study Timeline

• Study Start: 1999-12
• Primary Completion: 2001-11
• 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: 147

Inclusion Criteria

• Adult male or female patients with HIV type 1 infection

Exclusion Criteria

• Counter-indications according to summary of product characteristics (SPC) for Viramune tablets
• No persons under 18
• Pregnancy and breast-feeding
• Use of oral contraceptives
• Use of drugs affecting CYP450 3A metabolism

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Viramune	Viramune	-

Primary Outcome Measures

Name	Time	Method
Change in viral load (HIV-RNA)	Baseline, after 26 and 52 weeks
Change in CD4 cell count	Baseline, after 26 and 52 weeks
Change in glucose tolerance	Baseline, after 26 and 52 weeks	verbal rating scale
Change in lipid status (lipodystrophy, triglycerides, cholesterol)	Baseline, after 26 and 52 weeks	verbal rating scale

Secondary Outcome Measures

Name	Time	Method
Assessment of tolerability by physician and patient	after 26 and 52 weeks	verbal rating scale
Number of patients with adverse events	up to 52 weeks
Assessment of subjective well-being	up to 52 weeks	verbal rating scale