Status:
COMPLETED
Nelfinavir and M8 Drug-level Monitoring in HIV-1 Infection
Lead Sponsor:
University of Wisconsin, Madison
Collaborating Sponsors:
Agouron Pharmaceuticals
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to assess the impact of prospective drug level monitoring and dose-adjustment of nelfinavir (NFV) on the clinical and virologic outcomes in a group of HIV-infected patient...
Eligibility Criteria
Inclusion
- Antiretroviral naive or currently taking a nelfinavir containing HAART regimen where nelfinavir is the first protease inhibitor
- Patients willing to comply with the protocol
- Age greater than or equal to 18 years
- Virologically successful if already on an established regimen
Exclusion
- Prior use of a protease inhibitor exclusive of nelfinavir
- Required use or concomitant use of drugs that may interact with or are contraindicated with nelfinavir
- Use of immunomodulators or vaccines for HIV disease
- Intercurrent illness at the time of enrollment that, in the clinician's judgement, could influence the HIV RNA concentration
- Baseline ALT levels greater than five times the upper limit of normal
Key Trial Info
Start Date :
August 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2005
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00205283
Start Date
August 1 2003
End Date
August 1 2005
Last Update
March 22 2019
Active Locations (1)
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1
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792