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

Observational Study With Antiretroviral Treated Patients Switching Therapy Because of Therapeutic Reasons From Protease Inhibitor- or NNRTI-containing Regimens to Nevirapine Plus Two Nucleoside Reverse Transcriptase Inhibitor (NRTI) Regimens

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.

Study Overview

• Status: Completed
• Conditions: HIV Infections
• Intervention / Treatment: Drug: Viramune®

• Study Type: Observational
• Enrollment (Actual): 55

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

HIV treatment centres and HIV out-patient facilities

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Viramune®; Patients switching from protease inhibitor (PI) or nonnucleoside reverse transcriptase inhibitor (NNRTI) containing antiretroviral regimen to Viramune®	Drug: Viramune®

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: January 1, 2002
• Primary Completion (Actual): August 1, 2004

Study Registration Dates

• First Submitted: July 15, 2014
• First Submitted That Met QC Criteria: July 15, 2014
• First Posted (Estimate): July 16, 2014

Study Record Updates

• Last Update Posted (Estimate): July 16, 2014
• Last Update Submitted That Met QC Criteria: July 15, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Cytochrome P-450 Enzyme Inducers; Cytochrome P-450 CYP3A Inducers; Nevirapine
• Other Study ID Numbers: 1100.1395