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

• Status: Completed
• Trial end date: 2005-08-01
• Target enrollment: 0
• Participant gender: All

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 patients who have achieved virologic success while receiving a nelfinavir containing highly active antiretroviral therapy (HAART) regimen.

• Phase: N/A

Details

• Lead Sponsor: University of Wisconsin, Madison
• Collaborator: Agouron Pharmaceuticals
• Treatments: Nelfinavir

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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