Nelfinavir and M8 Drug-level Monitoring in HIV-1 Infection

Completed · Not applicable

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00205283

Run by

University of Wisconsin, Madison

People needed

20

Starts

2003-08-01

Expected to finish

2005-08-01

Last updated by the study team

2019-03-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Wisconsin Hospital and Clinics — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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