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

HIV Infections Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02191293
• Other study ID #: 1100.1402
• Status: Completed
• Phase: N/A
• First received: July 15, 2014
• Last updated: July 15, 2014
• Start date: May 2002

Study information

• Verified date: July 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 228
• Est. primary completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Viramune® tablets

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in viral load (HIV-RNA)		Baseline, up to 36 months	No
Primary	Changes in CD4 cell count		Baseline, up to 36 months	No
Secondary	Changes in body weight		Baseline, up to 36 months	No
Secondary	Changes in general well-being assessed on a 4-point scale		Baseline, up to 36 months	No
Secondary	Changes in lipid parameters	mg/dl	Baseline, up to 36 months	No
Secondary	Changes in glucose	mg/dl	Baseline, up to 36 months	No
Secondary	Changes in liver enzymes	U/l	Baseline, up to 36 months	No
Secondary	Number of patients with adverse events		up to 36 months	No

External Links

•   Link