Nelfinavir and M8 Drug-level Monitoring in HIV-1 Infection
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ClinicalTrials.gov Identifier: NCT00205283
Verified September 2005 by University of Wisconsin, Madison. Recruitment status was: Recruiting
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 patients who have achieved virologic success while receiving a nelfinavir containing highly active antiretroviral therapy (HAART) regimen.
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
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
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