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

Collecting Data in Patients With HIV Infection Type 1 After Switching From a Protease Inhibitor-containing Therapy Regimen and a Viral Load Below Detection Level to a Viramune®-Containing Therapy Regimen

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®).

Study Overview

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

• Study Type: Observational
• Enrollment (Actual): 147

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:

• 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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Viramune	Drug: Viramune

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 lipid status (lipodystrophy, triglycerides, cholesterol)	verbal rating scale	Baseline, after 26 and 52 weeks
Change in glucose tolerance	verbal rating scale	Baseline, after 26 and 52 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: December 1, 1999
• Primary Completion (Actual): November 1, 2001

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: Pathologic Processes; RNA Virus Infections; Virus Diseases; Blood-Borne Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Disease Attributes; Slow Virus Diseases; HIV Infections; Infections; Communicable Diseases; Acquired Immunodeficiency Syndrome; 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: 1100.1305