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-beingAssessment 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
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