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

University of Wisconsin (UW)

Status: Completed

Conditions: HIV Infections

Treatments: Drug: Nelfinavir

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00205283

2002-212

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)