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

Long-term Observational Study in Patients Under Anti-retroviral Combination Therapy Who Were Switched From Protease Inhibitors or Other NNRTI to Viramune® Plus Two Nucleoside Reverse Transcriptase Inhibitors (NRTI) for Reasons of Therapy. (Long-Term Switch)

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® tablets

• Study Type: Observational
• Enrollment (Actual): 228

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 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 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®	Drug: Viramune® tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Changes in viral load (HIV-RNA)	Baseline, up to 36 months
Changes in CD4 cell count	Baseline, up to 36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	mg/dl	Baseline, up to 36 months
Changes in glucose	mg/dl	Baseline, up to 36 months
Changes in liver enzymes	U/l	Baseline, up to 36 months
Number of patients with adverse events		up to 36 months

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: May 1, 2002
• Primary Completion (Actual): September 1, 2006

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: 1100.1402