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

Information source: Boehringer Ingelheim
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV Infections

Intervention: Viramune (Drug)

Phase: N/A

Status: Completed

Sponsored by: Boehringer Ingelheim

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®).

Clinical Details

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

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome:

Change in viral load (HIV-RNA)

Change in CD4 cell count

Change in lipid status (lipodystrophy, triglycerides, cholesterol)

Change in glucose tolerance

Secondary outcome:

Assessment of subjective well-being

Assessment of tolerability by physician and patient

Number of patients with adverse events

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Additional Information

Starting date: December 1999
Last updated: July 15, 2014

Page last updated: August 23, 2015

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