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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02191332
• Other study ID #: 1100.1305
• Status: Completed
• Phase: N/A
• First received: July 15, 2014
• Last updated: July 15, 2014
• Start date: December 1999

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

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®).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 147
• Est. primary completion date: November 2001
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Infection

Intervention

Drug:
• Viramune

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in viral load (HIV-RNA)		Baseline, after 26 and 52 weeks	No
Primary	Change in CD4 cell count		Baseline, after 26 and 52 weeks	No
Primary	Change in lipid status (lipodystrophy, triglycerides, cholesterol)	verbal rating scale	Baseline, after 26 and 52 weeks	No
Primary	Change in glucose tolerance	verbal rating scale	Baseline, after 26 and 52 weeks	No
Secondary	Assessment of subjective well-being	verbal rating scale	up to 52 weeks	No
Secondary	Assessment of tolerability by physician and patient	verbal rating scale	after 26 and 52 weeks	No
Secondary	Number of patients with adverse events		up to 52 weeks	No

External Links

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